The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index; 12 of the 17 sources its claims cite were checked for support.
Immunogenicity and safety of a booster dose of a self-amplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, non-inferiority trial
Open accessAbstract
Background Licensed mRNA COVID-19 vaccines require booster doses to sustain SARS-CoV-2-specific responses, creating the need for novel, broadly immunogenic vaccines. We aimed to compare the immunogenicity, safety, and tolerability of ARCT-154-a self-amplifying mRNA vaccine against SARS-CoV-2 D614G variant-with the BNT162b2 (Comirnaty; Pfizer-BioNTech) mRNA vaccine when administered as a fourth-dose booster. Methods This double-blind, multicentre, randomised, controlled, phase 3, non-inferiority trial, conducted at 11 outpatient clinical sites in Japan, enrolled healthy adults aged at least 18 years who had previously been immunised with two doses of an mRNA COVID-19 vaccine (BNT162b2 or mRNA-1273 [Spikevax; Moderna]) followed by a third dose of BNT162b2 at least 3 months before enrolment. Participants were randomly assigned, in a 1:1 ratio using an Interactive Response Technology system with a block size of four, and with stratification by age (18-64 years or ≥65 years) and by interval since last COVID-19 vaccination (<5 months or ≥5 months), to receive either ARCT-154 or BNT162b2 as a fourth-dose booster via deltoid intramuscular injection. Participants and investigators assessing outcomes were masked to group assignment. The primary objective, measured in per-protocol set 1 (consisting of participants with no evidence of previous SARS-CoV-2 infection who received their intended injection according to protocol), was to show that the immune response 28 days after the ARCT-154 vaccine was non-inferior to that of the BNT162b2 vaccine, measured in terms of both pseudovirus neutralising antibody geometric mean titre (GMT) ratios and seroresponse rates against the wild-type Wuhan-Hu-1 strain of SARS-CoV-2. Non-inferiority was declared when the lower limit of the 95% CI of the ARCT-154 to BNT162b2 GMT ratio exceeded 0·67, and when the lower limit for the difference in seroresponse rates exceeded -10%. Key secondary endpoints included the immune response against the omicron BA.4/5 subvariant, which was assessed for non-inferiority and superiority in per-protocol set 1. Safety was assessed in the full analysis set. This study was registered on the Japan Registry for Clinical Trials, jRCT 2071220080, and is ongoing. Findings Between Dec 13, 2022, and Feb 25, 2023, we enrolled and randomly assigned 828 participants to receive ARCT-154 (n=420) or BNT162b2 (n=408) vaccines as a fourth-dose booster. In per-protocol set 1, the GMTs of surrogate neutralising antibodies induced against the Wuhan-Hu-1 SARS-CoV-2 strain in the ARCT-154 group (5641 [95% CI 4321-7363]) were non-inferior to those in the BNT162b2 group (3934 [2993-5169]) when measured at 28 days after boosting, with a GMT ratio of 1·43 (95% CI 1·26-1·63). Seroresponse rates were 65·2% (95% CI 60·2-69·9) in the ARCT-154 group versus 51·6% (46·4-56·8) in the BNT162b2 group, a difference of 13·6% (95% CI 6·8-20·5). GMTs against the omicron BA.4/5 variant on day 29 were 2551 (1687-3859) in the ARCT-154 group and 1958 (1281-2993) in the BNT162b2 group-a GMT ratio of 1·30 (1·07-1·58)-with seroresponse rates of 69·9% (65·0-74·4) and 58·0% (52·8-63·1). Both boosters were equally well tolerated. No treatment-related deaths were reported, nor were there severe or serious adverse events considered to be causally associated related to study vaccination. One serious adverse event, a foot deformity reported in a participant in the BNT162b2 group, was observed but determined not to have a causal relationship to the study vaccination. One severe adverse event, a case of abnormal hepatic function in the ARCT-154 group, was considered to be related to study vaccine. Adverse events of special interest for detection of myocarditis and pericarditis included chest pain (one case in the ARCT-154 group and three cases in the BNT162b2 group) and shortness of breath (two cases in the BNT162b2 group), all of which were considered to have a reasonable possibility of being related to vaccination. Local reactions were reported by 398 (95%) of 420 participants receiving the ARCT-154 vaccine and 395 (97%) of 408 participants receiving the BNT162b2 vaccine, and solicited systemic adverse events by 276 (66%) of those receiving the ARCT-154 vaccine and 255 (63%) of those receiving the BNT162b2 vaccine. Adverse events were mainly mild in severity, occurring and resolving within 3-4 days after vaccination. Interpretation In adults who had previously received three doses of an mRNA COVID-19 vaccine, immune responses 28 days after an ARCT-154 booster dose were non-inferior to those observed after a BNT162b2 booster dose for the Wuhan-Hu-1 strain of SARS-CoV-2 and superior for the Omicron BA.4/5 variant. Increased immune responses at 28 days might provide increased likelihood of protection against these strains during this period and could also result in longer duration of protection. Further studies will assess the immunogenicity induced against more recent SARS-CoV-2 variants. Funding Japanese Ministry of Health, Labour, and Welfare. Translation For the Japanese translation of the abstract see Supplementary Materials section.
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Written from the paper’s full text.
TL;DR
In adults who had previously received three mRNA COVID-19 vaccine doses, a fourth-dose ARCT-154 self-amplifying RNA booster was non-inferior to BNT162b2 for Wuhan-Hu-1 neutralising antibody GMT and seroresponse at day 29, and superior for the omicron BA.4/5 subvariant. Safety through day 29 showed no treatment-related deaths and mainly mild adverse events.
Key findings
- Against Wuhan-Hu-1 in per-protocol set 1, day-29 GMTs were 5641 (95% CI 4321–7363) after ARCT-154 versus 3934 (2993–5169) after BNT162b2, with a GMT ratio of 1.43 (95% CI 1.26–1.63); seroresponse rates were 65.2% (60.2–69.9) versus 51.6% (46.4–56.8), a difference of 13.6% (6.8–20.5).
- Against omicron BA.4/5, day-29 GMTs were 2551 (1687–3859) after ARCT-154 versus 1958 (1281–2993) after BNT162b2, with a GMT ratio of 1.30 (1.07–1.58); seroresponse rates were 69.9% (65.0–74.4) versus 58.0% (52.8–63.1), a difference of 11.6% (4.9–18.3), meeting superiority criteria.
- Solicited local reactions were reported by 398 (95%) of 420 ARCT-154 recipients and 395 (97%) of 408 BNT162b2 recipients; solicited systemic adverse events by 276 (66%) and 255 (63%), respectively. Adverse events were mainly mild and resolved within 3–4 days.
- No treatment-related deaths occurred. One severe adverse event, abnormal hepatic function in the ARCT-154 group, was considered related to study vaccine; one serious adverse event, foot deformity in the BNT162b2 group, was judged unrelated. No myocarditis or pericarditis was detected among participants reporting chest pain or shortness of breath.
Methods
- Double-blind, multicentre, randomised, controlled, phase 3, non-inferiority trial at 11 outpatient clinical sites in Japan; 828 adults aged ≥18 years who had received three documented mRNA COVID-19 vaccine doses, with the third dose being BNT162b2 at least 3 months before enrolment, were randomly assigned 1:1 to ARCT-154 (n=420) or BNT162b2 (n=408) as a fourth-dose booster.
- Randomisation used an Interactive Response Technology system with block size four, stratified by age (18–64 or ≥65 years) and interval since last COVID-19 vaccination (<5 or ≥5 months); participants and outcome assessors were masked.
- Primary immunogenicity analysis was in per-protocol set 1 (385 ARCT-154, 374 BNT162b2), requiring no evidence of previous SARS-CoV-2 infection and receipt of intended injection per protocol; non-inferiority required the lower 95% CI of the ARCT-154 to BNT162b2 GMT ratio to exceed 0.67 and the lower 95% CI for seroresponse-rate difference to exceed −10%. GMTs were analysed by ANCOVA and seroresponse differences by the Miettinen-Nurminen method; safety was assessed in the full analysis set.
Limitations
- The paper states low numbers of older participants limited analysis of responses in older people; only 19 participants were aged ≥65 years, and small subgroup numbers prevented statistical demonstration of non-inferiority in some groups.
- The paper states immunogenicity and safety were monitored only up to day 29; durability at 3, 6, and 12 months and cellular immunity are still being assessed, and protective responses against currently dominant variants such as omicron XBB subvariants EG.5.1 and BA.2.86 and future variants still need evaluation.
- The paper notes observed seroconversion rates were low (65% ARCT-154, 52% BNT162b2), probably because high baseline immunity made a four-fold increase harder to achieve; the text also makes evident that no independent data monitoring committee was used.
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Claims the paper makes
49 Own result · 13 Own method · 11 Own interpretation · 5 Partly supported · 2 Supported · 2 Sources not found · 1 Supported so far · 1 Mixed support · 1 Couldn’t confirm · 1 No basis given · accuracy not yet measured
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“These vaccines are effective, but the immune response wanes in the months immediately following administration.8,9”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Implications of all the available evidence
What the sources say
- Partly supportedcites [8] Andrews, 2022, Covid-19 vaccine effectiveness against the omicron (B.1.1.529) variant, N Engl J Med sourceExperimental — accuracy not yet measured
The Discussion says antibodies wane with time since vaccination, which supports waning in one component of the immune response. But it also says cellular immunity probably continues to limit severe disease; the Results measure declining vaccine effectiveness, not a decline in the immune response as a whole. (LLM, conf=0.85)
- Partly supportedcites [9] Andrejko, 2023, Waning of 2-dose BNT162b2 and mRNA-1273 vaccine effectiveness against symptomatic SARS-CoV-2 infection accounting for depletion-of-susceptibles bias, Am J Epidemiol sourceExperimental — accuracy not yet measured
The Discussion (page not available in our copy) reports waning protection against symptomatic SARS-CoV-2 infection over the months after two doses of BNT162b2 or mRNA-1273. That supports declining vaccine effectiveness, but the study does not measure immune responses directly, so it does not establish that those responses themselves wane. (LLM, conf=0.84)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“As mRNA COVID-19 vaccines have been associated with cases of myocarditis in young adults, 19 we monitored for chest pain and shortness of breath in the 7 days after vaccination as indicators of myocarditis and pericarditis.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
What the sources say
- Supportedcites [19] Alami, 2023, Risk of myocarditis and pericarditis in mRNA COVID-19-vaccinated and unvaccinated populations: a systematic review and meta-analysis, BMJ Open source
The Introduction (page not available) reports myocarditis following mRNA COVID-19 vaccination, and the Discussion says rates in young males were higher than expected. This supports the cited association in young adults; the citing authors’ decision to monitor symptoms is their own. (LLM, conf=0.91)
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Supported
The cited sources that could be checked couldn’t confirm or dispute this claim.
In the paper
“This finding is consistent with data from the major phase 1/2/3/3b study of ARCT-154 (NCT05012943), which showed a vaccine safety profile similar to that of the saline placebo.18”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
What the sources say
- Could not verifycites [18] Nguyen, 2023, Safety and immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine, Res Sq sourceExperimental — accuracy not yet measured
The Introduction identifies a pooled phase 1/2/3a/3b study of ARCT-154, but reports its immunogenicity and efficacy, not its safety relative to placebo. A search for saline placebo, safety profile, and adverse events found no passage in our copy stating the claimed comparison. (LLM, conf=0.74)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Could not verify
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“One severe adverse event, a case of abnormal hepatic function in the ARCT-154 group, was considered to be related to study vaccine.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plaindirectSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The first primary immunogenicity endpoint, the ratio of surrogate neutralising antibody GMTs at day 29 after ARCT-154 and after BNT162b2, was 1•43 (95% CI 1•26-1•63).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Solicited systemic adverse events were reported by 276 (66%) of 420 participants who received the ARCT-154 vaccine and 255 (63%) of 408 participants who received the BNT162b2 vaccine (table 2).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plainn = 420- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Solicited local reactions were reported by 398 (95%) of 420 participants who received the ARCT-154 vaccine and 395 (97%) of 408 participants who received the BNT162b2 vaccine (table 2).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plainn = 420- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“solicited systemic adverse events by 276 (66%) of those receiving the ARCT-154 vaccine and 255 (63%) of those receiving the BNT162b2 vaccine.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“and from 866 (755-993) to 3934 (2993-5169) after BNT162b2, a geometric mean fold rise of 4•4 (4•0-4•8).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Relatively few participants-56 (7%) of 825were seropositive for the SARS-CoV-2 nucleocapsid protein, an indicator of recent infection within the previous 9-11 months.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plainn = 825- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- It may state two separate claims as one. 48
- Probably not a substantial claim. 16
- The quote only partly states this claim. 1
Some cited sources support this claim and some don’t — read each source’s verdict below.
In the paper
“For some COVID-19 vaccines, heterologous boosting has been shown to improve both the magnitude and the breadth of the immune response when compared with homologous boosters; 7,21,22 however, this has not been the case for mRNA vaccines, for which the response to a homologous mRNA booster is usually superior to the response to a heterologous non-mRNA booster.[10][11][12]”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
What the sources say
- Disputedcites [7] Au, 2022, Effectiveness of heterologous and homologous COVID-19 vaccine regimens: living systematic review with network meta-analysis, BMJ sourceExperimental — accuracy not yet measured
Split into 2 atoms — 0 confirmed, 1 partially supported, 1 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Checked by a reasoning model — may be wrong.
- Partly supportedcites [21] Munro, 2022, Lancet Infect Dis sourceExperimental — accuracy not yet measured
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
- Not checked — no full text of the sourcecites [22] Naito, 2022, Reactogenicity and immunogenicity of BNT162b2 or mRNA-1273 COVID-19 booster vaccinations after two doses of BNT162b2 among healthcare workers in Japan: a prospective observational study, Expert Rev Vaccines source
- Not matchedcites [10][11][12]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Disputed
Every source the paper cites for this claim was checked and supports it.
In the paper
“This study follows the primary phase 1/2/3a/3b study (NCT05012943), which demonstrated the safety of ARCT-154 compared with placebo and from which absolute efficacies were calculated as 56•6% (95% CI 48•7-63•3) against any COVID-19 and 95•3% (80•5-98•9) against severe COVID-19 when used as a primary vaccination regimen in Vietnamese adults.18”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Implications of all the available evidence
What the sources say
- Supportedcites [18] Nguyen, 2023, Safety and immunogenicity and efficacy of the self-amplifying mRNA ARCT-154 COVID-19 vaccine, Res Sq source
The Introduction (page not provided) identifies a pooled phase 1/2/3a/3b study of ARCT-154 as a primary series in Vietnam. It reports efficacy estimates of 56.6% against any COVID-19 and 95.3% against severe COVID-19, with the same confidence intervals as the citing sentence. (LLM, conf=0.93)
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“One such formulation, ARCT-154, encodes the spike protein of the B.1 lineage with the D614G (Asp614Gly) mutation, one of the earliest detected variants of SARS-CoV-2.17”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Implications of all the available evidence
What the sources say
- Partly supportedcites [17] Korber, 2020, Tracking changes in SARS-CoV-2 spike: evidence that D614G increases infectivity of the COVID-19 virus, Cell sourceExperimental — accuracy not yet measured
The Results section (“The D614G Variant”; page unavailable) documents D614G in early SARS-CoV-2 sequences, supporting its description as an early variant. Our copy does not identify the B.1 lineage or discuss ARCT-154, so it cannot support the claim about that vaccine’s formulation or encoded spike. (LLM, conf=0.88)
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The waning of neutralising antibodies induced by mRNA vaccines has been associated with increased susceptibility to infection with the omicron (B.1.1.529)variant of SARS-CoV-2.23”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
What the sources say
- Partly supportedcites [23] Gilboa, 2022, Durability of immune response after COVID-19 booster vaccination and association with COVID-19 omicron infection, JAMA Netw Open sourceExperimental — accuracy not yet measured
The Results (Association Between IgG Antibody Levels and Susceptibility to Omicron Infection) report faster neutralizing-antibody decline among infected than uninfected participants aged 65 or older. The Discussion likewise limits the observed association between waning and Omicron transmission to at least that age group. The citing sentence leaves out this population qualifier and presents the association more generally. (LLM, conf=0.87)
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“A systematic meta-analysis found that the effectiveness of mRNA vaccines against the omicron variant wanes to less than 20% within 6 months of primary immunisation and to less than 30% within 9 months of a booster dose.24”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
What the sources say
- Partly supportedcites [24] Menegale, 2023, Evaluation of waning SARS-CoV-2 vaccine-induced immunity: a systematic review and meta-analysis, JAMA Netw Open sourceExperimental — accuracy not yet measured
The Abstract Findings (page not available) report effectiveness below 20% at six months after a primary course and below 30% at nine months after a booster. However, the Results describe these as pooled estimates across different vaccine products, not estimates specifically for mRNA vaccines. (LLM, conf=0.86)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“However, in a small phase 1 trial reported in 2023, another saRNA vaccine elicited neutralising antibodies and T-cell responses against SARS-CoV-2 D614G strain and beta, delta, and omicron variants in older adults (aged ≥60 years) who had previously been immunised with the adenovirus-vectored ChAdOx1 nCoV-19 vaccine.25 Furthermore, this boost in immunity was shown to persist for at least 6 months.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
What the sources say
- Partly supportedcites [25] Palmer, 2023, GRT-R910: a self-amplifying mRNA SARS-CoV-2 vaccine boosts immunity for ≥6 months in previously-vaccinated older adults, Nat Commun sourceExperimental — accuracy not yet measured
Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Partly supported
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“Both ARCT-154 and BNT162b2 were well tolerated with mainly mild-tomoderate solicited adverse events, similar to those reported in previous studies of mRNA vaccine boosters.21,22”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
What the sources say
- Supportedcites [21] Munro, 2022, Lancet Infect Dis source
The Results report that solicited injection-site pain after fourth-dose BNT162b2 or mRNA-1273 was mostly mild or moderate, with severe solicited events in a small minority of participants. The Discussion describes these fourth-dose mRNA boosters as well tolerated. This paper supports the citation as an example of the prior booster studies used for comparison, not as a study of ARCT-154. (LLM, conf=0.88)
- Not checked — no full text of the sourcecites [22] Naito, 2022, Reactogenicity and immunogenicity of BNT162b2 or mRNA-1273 COVID-19 booster vaccinations after two doses of BNT162b2 among healthcare workers in Japan: a prospective observational study, Expert Rev Vaccines source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Supported
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“No reports of solicited local reactions or of systemic adverse events described as grade 4 or lifethreatening were received.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Adverse events of special interest for detection of myocarditis and pericarditis included chest pain (one case in the ARCT-154 group and three cases in the BNT162b2 group) and shortness of breath (two cases in the BNT162b2 group), all of which were considered to have a reasonable possibility of being related to vaccination.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plainconditionaln = 154- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Background immunity against the Wuhan-Hu-1 strain of SARS-CoV-2 was evident in both the ARCT-154 and the BNT162b2 groups, with similar baseline GMTs in both groups in per-protocol set 1 (figure 2).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Seroresponse rates were 65•2% (95% CI 60•2-69•9) in the ARCT-154 group versus 51•6% (46•4-56•8) in the BNT162b2 group, a difference of 13•6% (95% CI 6•8-20•5).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one. The quote only partly states this claim.
- Rests on an assumption: The pre-specified non-inferiority margins (GMT ratio 0.67 and seroresponse rate difference -10%) are clinically acceptable.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Up to day 29, the interim cut-off presented in this analysis, no deaths, adverse events of special interest, or medically significant adverse events were reported (table 2).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Seroresponse rates against the Wuhan-Hu-1 strain of SARS-CoV-2 on day 29 were 65•2% (95% CI 60•2-69•9) in the ARCT-154 group and 51•6% (46•4-56•8) in the BNT162b2 group, a difference of 13•6% (95% CI 6•8-20•5).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Two recipients of the ARCT-154 vaccine reported chest pain (table 2): one within 1 day of vaccination, which the respective investigator considered to be related to the vaccine, and the other 6 days after vaccination, which was considered unrelated.Four recipients of the BNT162b2 vaccine reported five symptoms of interest: three cases of chest pain occurring within 1-3 days of vaccination and two”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In per-protocol set 1, the GMTs of surrogate neutralising antibodies induced against the Wuhan-Hu-1 SARS-CoV-2 strain in the ARCT-154 group (5641 [95% CI 4321-7363]) were non-inferior to those in the BNT162b2 group (3934 [2993-5169]) when measured at 28 days after boosting, with a GMT ratio of 1•43 (95% CI 1•26-1•63).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The pre-specified non-inferiority margins (GMT ratio 0.67 and seroresponse rate difference -10%) are clinically acceptable.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The majority of the reported unsolicited adverse events were mild or moderate, but seven were described as severe (grade 3): one in the ARCT-154 group (a case of abnormal hepatic function, assessed as related to the investigative vaccine by the investigators) and six in the BNT162b2 group (three cases of nasopharyngitis and one case each of pyrexia, ankle fracture, and foot deformity, none of”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plaindirectn = 3- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“759 individuals were included in per-protocol set 1”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plainn = 759- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“after three doses of BNT162b2, the GMTs against omicron BA.4/5 were 2088 (95% CI 1271-3429; n=306) after ARCT-154 and 1479 (884-2473; n=298) after a fourth dose of BNT162b2, a GMT ratio of 1•41 (1•13-1•77).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plainn = 306- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“At day 29, both groups displayed marked increases in surrogate neutralising antibody GMTs, from 813 (95% CI 716-924) to 5641 (4321-7363) after ARCT-154, a geometric mean fold rise of 6•7 (95% CI 6•0-7•5)”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Non-inferiority of the responses against Wuhan-Hu-1 and omicron BA.4/5 after ARCT-154, compared with the responses after BNT162b2, were also indicated when the groups were further separated according to age category (<65 years vs ≥65 years), gender (male vs female), or interval since the last COVID-19 booster vaccine before the study vaccine was administered (<5 months vs ≥5 months; appendix 2 pp”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“GMTs against the omicron BA.4/5 variant on day 29 were 2551 (1687-3859) in the ARCT-154 group and 1958 (1281-2993) in the BNT162b2 group-a GMT ratio of 1•30 (1•07-1•58)-with seroresponse rates of 69•9% (65•0-74•4) and 58•0% (52•8-63•1).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“No treatment-related deaths were reported, nor were there severe or serious adverse events considered to be causally associated related to study vaccination.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The GMT ratio was 1•30 (95% CI 1•07-1•58), in which the lower limit of the 95% CI exceeded the non-inferiority criterion of 0•67”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“In those previously immunised with two doses of mRNA-1273 and one dose of BNT162b2, GMTs were 4012 (1933-8329; n=78) after ARCT-154 and 3836 (1884-7809; n=298) after BNT162b as fourth doses, a GMT ratio of 1•05 (0•713-1•54).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plainn = 78- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The mean age of participants in the full analysis set was 45•7 years (SD 11•8, range 18-77), of whom 485 (59%) were female and 340 (41%) were male.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“One serious adverse event, a foot deformity reported in a participant in the BNT162b2 group, was observed but determined not to have a causal relationship to the study vaccination.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“As with the local reactions, solicited systemic adverse events were mainly mild and transient, starting and resolving within 1-3 days after vaccination (figure 3; appendix 2 p 12).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Adverse events were mainly mild in severity, occurring and resolving within 3-4 days after vaccination.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Most participants (658 [80%] of 825) had received the BNT162b2 vaccine exclusively for all three doses; 166 (20%) had received two doses of mRNA-1273 before receiving a third-dose booster of BNT162b2, and one (<1%) received one dose of mRNA-1273 before two doses of BNT162b2.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plainn = 825- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“GMTs against the omicron BA.4/5 variant on day 29 were 2551 (1687-3859) in the ARCT-154 group and 1958 (1281-2993) in the BNT162b2 group-a GMT ratio of 1•30 (1•07-1•58)-with seroresponse rates of 69•9% (65•0-74•4) and 58•0% (52•8-63•1).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“817 (99%) of 825 still had neutralising antibodies against the Wuhan-Hu-1 strain of SARS-CoV-2 before they received the study vaccine, while 654 (79%) had neutralising antibodies against the omicron BA.4/5 subvariant.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plainn = 825- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Most reported local reactions were transient, starting within 1 day or 2 days of vaccination and resolving by day 4 (appendix 2 p 11), and were described as mild or moderate in severity.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“GMTs increased from 275 (95% CI 227-335) on day 1 to 2551 (1687-3859) on day 29 in the ARCT-154 group (geometric mean fold rise of 8•0 [95% CI 7•0-9•1]), and from 292 (236-360) on day 1 to 1958 (1281-2993) on day 29 in the BNT162b2 group (5•7 [5•0-6•4]).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“One serious adverse event, reported in a participant in the BNT162b2 group, was described as a foot deformity, and the investigators did not consider it to have any causal relationship to the study vaccination.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plainSingle case- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Similar immune responses were observed across subgroups, including in men and women and in older individuals (≥65 years), although the low numbers of participants in some groups (eg, only 19 participants were aged ≥65 years) mean that caution should be exercised in the interpretation of these data (appendix 2 pp 5-7).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
hedgedn = 19- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Six participants, two who received the ARCT-154 vaccine and four who received the BNT162b2 vaccine, reported one or both symptoms.Although one case in the ARCT-154 group and all four cases in the BNT162b2 group were considered to be related to the study vaccines, myocarditis and pericarditis were excluded after evaluation by the investigators or a cardiologist.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
plaindirectn = 6- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“This double-blind, multicentre, randomised, controlled, phase 3, non-inferiority trial was conducted at 11 out patient clinical sites in Japan (appendix 2 p 2).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Study design
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
In the paper
“Preclinical studies suggest that saRNA vaccines, which are not restricted to COVID-19, require lower doses to enhance antigen expression than conventional mRNA-based vaccines and could improve the efficacy and duration of protection.[14][15][16]”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Implications of all the available evidence
What the sources say
- Not matchedcites [14][15][16]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Not matched
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“At enrolment, participants were randomly assigned (1:1) using an Interactive Response Technology system with a block size of four, stratified by age (18-64 years or ≥65 years) and the interval since last COVID-19 vaccination (<5 months or ≥5 months), to receive either the ARCT-154 or the BNT162b2 vaccine.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Randomisation and masking
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
In the paper
“Administering a booster dose of the same vaccine type, known as homologous boosting, extends the duration of response but does not broaden it against the antigenic drift that occurs as new variants emerge.[10][11][12]”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Implications of all the available evidence
What the sources say
- Not matchedcites [10][11][12]
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Not matched
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Randomisation lists were generated by external unmasked statisticians who had no further role in endpoint analyses.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Randomisation and masking
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“This study was registered on the Japan Registry for Clinical Trials, jRCT 2071220080, and is ongoing.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“For the immunogenicity evaluations, the ratio of the neutralising antibody GMTs against the Wuhan-Hu-1 SARS-CoV-2 strain measured 28 days after booster vaccination between the two groups was assumed to be 1•0 with a standard deviation of 0•40, and the seroresponse rate of each group was assumed to be 85%.To obtain a statistical power of 90% to detect the non-inferiority of ARCT-154 compared with B”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Statistical analysis
plainn = 780- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“There was no independent data monitoring committee.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Statistical analyses were done using SAS, version 9.4.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Furthermore, both the ARCT-154 and BNT162b2 vaccines were reasonably well tolerated in this population, with no reports of deaths, serious adverse events, or medically significant adverse events that were causally associated with vaccination.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Participants and investigators assessing outcomes were masked to group assignment.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Because the lower limit of the 95% CI exceeded the predefined margin of -10%, the primary objective-the non-inferiority of the immune response to ARCT-154 compared with the response to BNT162b2was also met, both in terms of GMTs and seroresponse rates.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Only data up to day 29 are reported here; safety monitoring up to 12 months is ongoing.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Procedures
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The study protocol (appendix 2) was approved by the institutional review boards of all participating sites.The study was conducted according to the ethical principles of the Declaration of Helsinki and Good Clinical Practice.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Study design
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“The funder of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the report.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Role of the funding source
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Occurrences of the symptoms of interest, chest pain and shortness of breath, between days 1 and 7 were specifically monitored as indicators of potential myocarditis and pericarditis.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“We show that a 5 μg booster dose of ARCT-154 is safe, is well tolerated, and induces a robust immune response to the Wuhan-Hu-1 strain of SARS-CoV-2 that is non-inferior to the response induced by a homologous 30 μg booster dose of the BNT162b2 mRNA vaccine.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Added value of this study
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Rests on an assumption: The pre-specified non-inferiority margins (GMT ratio 0.67 and seroresponse rate difference -10%) are clinically acceptable.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Vaccines were prepared in opacified syringes and administered by study staff who were unmasked to the randomisation code supplied by the study sponsor and who had no further role in the study.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Randomisation and masking
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Notably, as the lower limit of the 95% CI for the GMT ratio was greater than 1•0, and the same lower limit for the difference in seroresponse rate was greater than 0%, the criteria for superiority of the ARCT-154 response over the BNT162b2 response were met.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Our study has some limitations, notably the low numbers of older participants, which limits analysis of the response in older people and a further assessment will be required in this population.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Although antibody titres were high after boosting in this study, the observed seroconversion rates were low: 65% for ARCT-154 and 52% for BNT162b2.These seroconversion rates were probably due to the high level of immunity at baseline following previous immunisations, making a four-fold increase more difficult to achieve.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Nevertheless, this saRNA platform appears to induce non-inferior, and for the omicron BA.4/5 subvariant, superior, heterologous responses compared with homologous boosting with an mRNA vaccine-a characteristic that is highly desirable in a period of continued viral evolution.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Discussion
hedgedconditional- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The paper relies on this without support.
The pre-specified non-inferiority margins (GMT ratio 0.67 and seroresponse rate difference -10%) are clinically acceptable.
“Non-inferiority was declared when the lower limit of the 95% CI of the ARCT-154 to BNT162b2 GMT ratio exceeded 0•67, and when the lower limit for the difference in seroresponse rates exceeded -10%.”
The paper relies on this without support.
Neutralising antibody titres and seroresponse rates are valid correlates of protection against SARS-CoV-2 infection and disease.
“Increased immune responses at 28 days might provide increased likelihood of protection against these strains during this period and could also result in longer duration of protection.”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Rated major: it would touch a result — a value a result rests on, reported and recomputed p-values on opposite sides of the significance level, two passages that conflict with no sign which is right, or a cited work retracted before this paper was published.
In the paper
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
“No treatment-related deaths were reported, nor were there severe or serious adverse events considered to be causally associated related to study vaccination.”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Abstract
“One severe adverse event, a case of abnormal hepatic function in the ARCT-154 group, was considered to be related to study vaccine.”
Rated minor: it would not touch a result — a value no result rests on, a p-value that stays on the same side of the significance level, or a conflict that is clerical, resolved elsewhere in the paper, or outside its own findings.
In the paper
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
“In those previously immunised with two doses of mRNA-1273 and one dose of BNT162b2, GMTs were 4012 (1933-8329; n=78) after ARCT-154 and 3836 (1884-7809; n=298) after BNT162b as fourth doses, a GMT ratio of 1•05 (0•713-1•54).”
§ Immunogenicity and safety of a booster dose of a selfamplifying RNA COVID-19 vaccine (ARCT-154) versus BNT162b2 mRNA COVID-19 vaccine: a double-blind, multicentre, randomised, controlled, phase 3, noninferiority trial > Results
“mRNA-1273 + mRNA-1273 + BNT162b2 87 (21%) 79 (19%) 166 (20%)”
Citations
Cites
Korber, B., Fischer, W. M., Gnanakaran, S., Yoon, H., Theiler, J., Abfalterer, W., Hengartner, N., Giorgi, E. E., Bhattacharya, T., Foley, B., et al. (2020) · Cell · doi:10.1016/j.cell.2020.06.043 · Cited by 4,281
Effectiveness of COVID-19 vaccines against the Omicron (B.1.1.529) variant of concern
Andrews, N., Stowe, J., Kirsebom, F., Toffa, S., Rickeard, T., Gallagher, E., Gower, C., Kall, M., Groves, N., O’Connell, A.-M., et al. (2021) · doi:10.1101/2021.12.14.21267615 · Cited by 2,420
Araf, Y., Akter, F., Tang, Y., Fatemi, R., Parvez, M. S. A., Zheng, C., & Hossain, M. G. (2022) · Journal of Medical Virology · doi:10.1002/jmv.27588 · Cited by 862
Homologous and Heterologous Covid-19 Booster Vaccinations
Atmar, R. L., Lyke, K. E., Deming, M. E., Jackson, L. A., Branche, A. R., Sahly, H. M. E., Rostad, C. A., Martin, J. M., Johnston, C., Rupp, R. E., et al. (2022) · New England Journal of Medicine · doi:10.1056/nejmoa2116414 · Cited by 646
Vogel, A. B., Lambert, L., Kinnear, E., Busse, D., Erbar, S., Reuter, K. C., Wicke, L., Perkovic, M., Beissert, T., Haas, H., et al. (2018) · Molecular Therapy · doi:10.1016/j.ymthe.2017.11.017 · Cited by 501
Self-amplifying RNA vaccines for infectious diseases
Bloom, K., van den Berg, F., & Arbuthnot, P. (2021) · Gene Therapy · doi:10.1038/s41434-020-00204-y · Cited by 487
Ai, J., Zhang, H., Zhang, Y., Lin, K., Zhang, Y., Wu, J., Wan, Y., Huang, Y., Song, J., Fu, Z., et al. (2022) · Emerging Microbes & Infections · doi:10.1080/22221751.2021.2022440 · Cited by 339
Self-citationEvaluation of Waning of SARS-CoV-2 Vaccine–Induced Immunity: A Systematic Review and Meta-analysis
Menegale, F., Manica, M., Zardini, A., Guzzetta, G., Marziano, V., d'Andrea, V., Trentini, F., Ajelli, M., Poletti, P., & Merler, S. (2023) · JAMA Network Open · doi:10.1001/jamanetworkopen.2023.10650 · Cited by 280
Neutralization against BA.2.75.2, BQ.1.1, and XBB from mRNA Bivalent Booster
Davis-Gardner, M. E., Lai, L., Wali, B., Samaha, H., Solis, D., Lee, M., Morrison-Porter, A., Hentenaar, I., Yamamoto, F. F., Godbole, S., et al. (2022) · New England Journal of Medicine · doi:10.1056/nejmc2214293 · Cited by 254
Omicron: What Makes the Latest SARS-CoV-2 Variant of Concern So Concerning?
Jung, C., Kmieć, D., Koepke, L., Zech, F., Jacob, T., Sparrer, K. M. J., & Kirchhoff, F. (2022) · Journal of Virology · doi:10.1128/jvi.02077-21 · Cited by 207
Cited by
Sorted by citations
mRNA vaccines for infectious diseases — advances, challenges and opportunities
Pardi, N., & Krammer, F. (2024) · Nature Reviews Drug Discovery · doi:10.1038/s41573-024-01042-y · Cited by 252
“…a recent clinical study reported non-inferiority of the ARCT-154 (Arcturus) COVID-19 saRNA-LNP vaccine compared to the BNT162b2 nucleoside-modified mRNA formulation, used as a booster dose in individuals previously vaccinated three times with any of the two approved COVID-19 mRNA vaccines 51 .”
The advent of clinical self-amplifying RNA vaccines
Casmil, I. C., Jin, J., Won, E.-J., Huang, C., Liao, S., Cha‐Molstad, H., & Blakney, A. K. (2025) · Molecular Therapy · doi:10.1016/j.ymthe.2025.03.060 · Cited by 111
Hồ, N. T., Hughes, S. G., Ta, V. T., Lan, P. T., Đỗ, Q., Nguyễn, T. V., Phạm, A. T. V., Đặng, M. T. N., Nguyễn, L. V., Trịnh, Q. V., et al. (2024) · Nature Communications · doi:10.1038/s41467-024-47905-1 · Cited by 93
“…might alsobe associated with cultural differences inthe reporting of subjective adverse events when used a booster dose in mRNA-primed adults ARCT-154 had an almost identical reactogenicity pro fi le as the mRNA vaccine, BNT162b2, when observed in a head-to-head comparison in Japan adults 25 .”
InfluentialSelf-citationRNA chemistry and therapeutics
Wang, S., Weissman, D., & Dong, Y. (2025) · Nature Reviews Drug Discovery · doi:10.1038/s41573-025-01237-x · Cited by 109
Frameworks for transformational breakthroughs in RNA-based medicines
Androsavich, J. R. (2024) · Nature Reviews Drug Discovery · doi:10.1038/s41573-024-00943-2 · Cited by 100
“Immune responses for ARCT-154 at 5 µg were determined to be non-inferior or superior to homologous conventional boosters at 30 µg, depending on the SARS-CoV-2 strain considered, and with a comparable side effect profile 111 .”
Metadata
- Authors
- Oda, Y., Kumagai, Y., Kanai, M., Iwama, Y., Okura, I., Minamida, T., Yagi, Y., Kurosawa, T., Greener, B., Zhang, Y., & Walson, J. L.
- Affiliations
- Meiji Seika Pharma Co., Ltd. (Japan) (JP)
- Kitasato Institute Hospital (JP)
- Arcturus Therapeutics (United States) (US)
- Corresponding author
- Walson, Judd L
- Venue
- The Lancet Infectious Diseases
- Publisher
- Elsevier BV
- Published
- 2024-04
- Volume
- 24
- Issue
- 4
- Pages
- 351-360
- ISSN
- 1473-3099 (ISSN-L)
- OpenAlex
- W4389990639
- Cited by
- 123
- References
- 27
- Citations by year
- 2026: 32 · 2025: 58 · 2024: 31
- FWCI
- 23.33
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet Infectious Diseases (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Japan Labour Health and Welfare Organization
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Keywords
- self-amplifying RNA vaccine, COVID-19 booster vaccination, BNT162b2, mRNA vaccines, SARS-CoV-2, immunogenicity, vaccine safety, neutralizing antibodies, non-inferiority, mRNA-1273
- MeSH terms
- Immunogenicity, Vaccine, COVID-19, SARS-CoV-2, COVID-19 Vaccines, mRNA Vaccines, BNT162 Vaccine, Adolescent, Adult, Aged, Antibodies, Viral, Double-Blind Method, Humans, Middle Aged, RNA, Young Adult
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
A language model drew the claims from the paper on 2026-10-11, under version 3 of the claim definition (model deepseek-v4.1-flash, prompt extract-v3).
A second model labelled each claim on 2026-10-11 (model jev-1.13-20260917, definition revision gold-guideline-v0.2).
Cited sources are checked with a language model’s help (gpt-6-sol).
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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