Safety and immunogenicity of a prefusion non-stabilized spike protein mRNA COVID-19 vaccine: a phase I trial

May combine two claims.

ChulaCov19 is a wild-type non-stabilized spike-protein-encoded mRNA vaccine encapsulated with a different LNP that is thermostable at 2-8 °C for at least 3 months.

“Unlike currently approved mRNA vaccines, such as Pfizer/BNT and Moderna 4 , ChulaCov19 is a wild-type non-stabilized spike-protein-encoded mRNA vaccine encapsulated with a different LNP that is thermostable at 2-8 °C for at least 3 months.”

• cites [4] Chaudhary, N., Weissman, D. & Whitehead, K. A. mRNA vaccines for infectious diseases: principles, delivery and clinical translation. Nat. Rev. Drug Discov. 20, 817–838 (2021). sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Among approved vaccines, mRNA vaccines have the highest efficacy.

“Among approved vaccines, mRNA vaccines have the highest efficacy 2 .”

• cites [2] Khoury, D. S. et al. Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection. Nat. Med. 27, 1205–1211 (2021). sourcePartly supported

  The Results (p. 2) compare reported phase 3 efficacy across seven vaccines, including the mRNA vaccines mRNA-1273 and BNT162b2. Our copy does not state that mRNA vaccines rank highest, or establish that the comparison covers all approved vaccines. (LLM, conf=0.78)

  Experimental — accuracy not yet measured

May combine two claims.

Two doses of the ChulaCov19 vaccine may not be effective against the Omicron variant and a third dose is required.

“In terms of the Omicron variant, as reported in approved Covid-19 mRNA vaccines, two doses of the ChulaCov19 vaccine may not be effective and a third dose is required 5 .”

• cites [5] Thompson, M. G. et al. Effectiveness of a third dose of mRNA vaccines against COVID-19-associated emergency department and urgent care encounters and hospitalizations among adults during periods of delta and omicron variant predominance - VISION Network, 10 States, August 2021-January 2022. MMWR Morb. Mortal. Wkly Rep. 71, 139–145 (2022). sourcePartly supported

  The Discussion recommends a third mRNA vaccine dose during Omicron predominance because two-dose effectiveness was reduced. However, the study examined Moderna and Pfizer-BioNTech vaccines, not ChulaCov19, and it found that two doses still provided some protection against COVID-19–associated emergency or urgent care encounters and hospitalizations. It therefore does not establish that two ChulaCov19 doses may be ineffective or that a third ChulaCov19 dose is required. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

May combine two claims.

Due to escape of the Omicron variant from current approved vaccines, the efficacy of all current vaccines is reduced and a new variant-specific analysis is required.

“However, due to escape of the Omicron variant from current approved vaccines, the efficacy of all current vaccines is reduced and a new variant-specific analysis is therefore required [13][14][15] .”

• cites [13] Cele, S. et al. Omicron extensively but incompletely escapes Pfizer BNT162b2 neutralization. Nature 602, 654–656 (2022). sourcePartly supported

  The Abstract (page not indicated) reports a 22-fold reduction in Omicron neutralization after Pfizer BNT162b2 vaccination and predicts reduced protection against symptomatic infection. The study examines that vaccine, not all approved vaccines, so it does not support the claim that efficacy is reduced for every current vaccine. The call for a new variant-specific analysis is the citing authors’ conclusion. (LLM, conf=0.88)

  Experimental — accuracy not yet measured
• cites [14] Schmidt, F. et al. Plasma neutralization of the SARS-CoV-2 omicron variant. N. Engl. J. Med. 386, 599–601 (2021). sourcePartly supported

  The Results (vaccine-recipient plasma section; page unavailable) show substantially reduced neutralization of Omicron after two mRNA vaccine doses, and the Discussion reports low Omicron-neutralizing titers in some Ad26 recipients. The study measured plasma neutralization, not the clinical efficacy of all approved vaccines. Its Discussion calls for broadly based vaccination strategies, but does not state that a new variant-specific analysis is required. (LLM, conf=0.86)

  Experimental — accuracy not yet measured
• cites [15] Sievers, B. L. et al. Antibodies elicited by SARS-CoV-2 infection or mRNA vaccines have reduced neutralizing activity against Beta and Omicron pseudoviruses. Sci. Transl. Med. 14, eabn7842 (2022). sourcePartly supported

  The Results report reduced neutralizing antibody responses against Omicron after mRNA vaccination, and the Discussion says mRNA vaccines will likely have somewhat reduced effectiveness against variants as antigenically drifted as Omicron. The paper does not establish reduced clinical efficacy for all current vaccines; it studies neutralization after mRNA vaccination. Its Introduction motivates variant-specific assessment, but does not say that a new analysis is required. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

Administering a third dose of COVID-19 mRNA vaccine as a booster has enabled a substantial increase in GMT against WT, Delta and Omicron variants.

“Administering a third dose of COVID-19 mRNA vaccine as a booster has enabled a substantial increase in GMT against WT, Delta and Omicron variants 16 .”

• cites [16] Barda, N. et al. Effectiveness of a third dose of the BNT162b2 mRNA COVID-19 vaccine for preventing severe outcomes in Israel: an observational study. Lancet 398, 2093–2100 (2021). sourcePartly supported

  The Introduction (page not available) reports a pronounced humoral response after a third BNT162b2 dose. It does not report geometric mean titres (GMT) or an increase measured against WT, Delta, and Omicron; the study evaluates severe clinical outcomes instead. (LLM, conf=0.82)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Due to greater vaccine escape of Omicron variants, the cross-neutralizing titre against the Omicron variant is several folds lower than against WT, therefore the decline rate is much faster.

“In addition, due to a greater vaccine escape of Omicron variants, the cross-neutralizing titre against the Omicron variant is several folds lower than against WT, therefore the decline rate is much faster 15 .”

• cites [15] Sievers, B. L. et al. Antibodies elicited by SARS-CoV-2 infection or mRNA vaccines have reduced neutralizing activity against Beta and Omicron pseudoviruses. Sci. Transl. Med. 14, eabn7842 (2022). sourcePartly supported

  The Results section reports reduced Omicron neutralizing titers relative to D614 and describes fold reductions after vaccination (Fig. 2C). It also reports that titers against all variants waned by day 210 after two vaccine doses, but does not establish that Omicron titers declined faster than WT titers or that a lower starting titer caused a faster decline. (LLM, conf=0.87)

  Experimental — accuracy not yet measured

May combine two claims.

Our data support the idea that the spike does not need to be prefusion stabilized to induce a potent and protective response, unlike respiratory syncytial virus.

“Our data support the idea that the spike does not need to be prefusion stabilized to induce a potent and protective response, unlike respiratory syncytial virus 8 .”

• cites [8] McLellan, J. S. et al. Structure-based design of a fusion glycoprotein vaccine for respiratory syncytial virus. Science 342, 592–598 (2013). sourcePartly supported

  The Immunogenicity section reports that prefusion-stabilized RSV F elicited neutralizing titers about 4–8 times higher than postfusion F, supporting the contrast the citing sentence draws. But postfusion F also elicited titers above the stated protective threshold, so the paper does not establish that prefusion stabilization is necessary for an RSV-protective response. Page numbers were not available in our copy. (LLM, conf=0.86)

  Experimental — accuracy not yet measured

The quote only partly states this claim.

Two doses of ChulaCov19 at 50 μg elicited a substantial decline in GMT against the Omicron variant compared with WT.

“PsVNT-50 test results for a new variant, Omicron, showed that two doses of ChulaCov19 at 50 mg elicited a substantial decline in GMT against the Omicron variant compared with WT (Supplementary Fig. 2).”

May combine two claims.

In the adult cohort, PsVNT-50 GMTs against WT at day 50 for 10, 25 and 50 μg and for the HCS panel were 885.3, 902.9, 1,273.1 and 471.2, respectively.

“In the adult cohort, PsVNT-50 GMTs (95% CI) of ChulaCov19 against WT at day 50 for 10, 25 and 50 μg and for the HCS panel were 885.3 (95%CI, 438.2-1,788.7),902.9 (445.5-1,829.7),1,273.1 (874.2-1,854) and 471.2 (290.5-764.5),respectively (Fig. 2d).”

May combine two claims.

GMT of responses against wild-type virus were both dose- and age-dependent, and markedly increased from day 29 to day 50 for the 10, 25 and 50 μg doses.

“GMT of the responses against wild-type (WT) virus were both dose-and age-dependent, and markedly increased from day 29 to day 50 for the 10, 25 and 50 μg doses (Fig. 2c).”

May combine two claims.

In the elderly cohort, anti-RBD GMTs were dose-dependent but lower than in the adult cohort.

“In the elderly cohort, anti-RBD GMTs were also dose-dependent but lower than observed in the adult cohort (Fig. 2a and Supplementary Table 6).”

May combine two claims.

ChulaCov19 at 50 μg elicited higher neutralizing antibodies than human convalescent sera, with strong T-cell responses.

“ChulaCov19 at 50 μg is well tolerated and elicited higher neutralizing antibodies than human convalescent sera, with strong T-cell responses.”

May combine two claims.

There was a small increase in particle size when vaccine was stored at 2-8 °C at 6 months, but all remained within the acceptance criteria of 50-120 nm.

“However, there was a small increase in particle size (72, 76 vs 78 nm, respectively; nevertheless, all remained within the acceptance criteria of 50-120 nm) when vaccine was stored at 2-8 °C at 6 months.”

May combine two claims.

There were no remarkable changes in any parameter after 3 months storage at 2-8 °C and small changes after 6 months, but all results remained within specification.

“There were no remarkable changes in any parameter after 3 months storage at 2-8 °C and small changes after 6 months, but all the results remained within specification”

May combine two claims.

In a phase 1 trial, three dosages of ChulaCov19 vaccine were well tolerated, with no serious adverse effects observed in either age-group.

“In a phase 1 trial, three dosages of ChulaCov19 vaccine were well tolerated, with no serious adverse effects observed in either age-group.”

May combine two claims. The quote only partly states this claim.

In the adult cohort 4 weeks after the second vaccination, anti-RBD antibody GMT was significantly higher than for human convalescent sera, with GMRs of 3.78, 3.23 and 7.74 at 10, 25 and 50 μg doses, respectively.

“of anti-RBD antibody was significantly higher than for human convalescent sera 4 weeks after COVID-19 diagnosis (Fig. 2a), with geometric mean ratios (GMR) of 3.78 (95%CI 1.64-8.68),3.23 (1.41-7.42)and 7.74 (3.37-17.77),respectively (P ≺ 0.01) (Supplementary Table 10).”

May combine two claims.

All parameters remained in line with the vaccine specification at 6 months for all storage conditions and there were no substantial changes for any parameter tested at -75 °C and -20 °C.

“Thus, all parameters remained in line with the vaccine specification at 6 months for all storage conditions and there were no substantial changes for any parameter tested at -75 °C and -20 °C.”

May combine two claims.

The phase I data show that ChulaCov19 elicited robust humoral and T-cell responses, which were often greater than those of the BioNTech/Pfizer vaccine that contains the di-proline modification.

“The phase I data presented here show that Chula-Cov19 elicited robust humoral and T-cell responses, which were often greater than those of the BioNTech/Pfizer vaccine that contains the di-proline modification.”

May combine two claims.

Injection site pain was the most common adverse effect, while fever, chills, headache and myalgia were reported to be dose-dependent and more frequent after the second dose.

“Injection site pain was the most common adverse effect, while fever, chills, headache and myalgia were reported to be dose-dependent and more frequent after the second dose.”

May combine two claims.

In our study, administration of 2 doses of ChulaCov19 vaccine induced neutralizing antibodies with less potency for the Omicron variant, although only mild-to-moderate reductions in efficacy against other variants of concern were observed.

“In our study, administration of 2 doses of ChulaCov19 vaccine induced neutralizing antibodies with less potency for the Omicron variant, although only mild-to-moderate reductions in efficacy against other variants of concern (VOCs) were observed (Fig. 3).”

May combine two claims.

Adverse effects were both less frequent and milder among the elderly participants.

“Adverse effects were both less frequent and milder among the elderly participants.”

May combine two claims.

All doses of ChulaCov19 generated strong T-cell responses and the higher doses (25 and 50 μg) elicited higher % of spike-specific IL2+CD4+ T cells and % of IFNγ+CD4+ T cells than the 10 μg dose (P < 0.01 and P < 0.05, respectively).

“All doses of ChulaCov19 generated strong T-cell responses and the higher doses (25 and 50 μg) elicited higher % of spike-specific IL2+CD4+ T cells and % of IFNγ+CD4+ T cells than the 10 μg dose (P < 0.01 and P < 0.05, respectively).”

May combine two claims.

At 4 weeks after dose 2, there was a further rise in all tested antibodies and all 3 doses elicited microVNT-50 GMTs higher than those of HCS, with a GMT ratio that is 4-8-fold (P < 0.01).

“At 4 weeks after dose 2, there was a further rise in all tested antibodies and all 3 doses elicited microVNT-50 GMTs higher than those of HCS, with a GMT ratio that is 4-8-fold (P < 0.01).”

May combine two claims.

ChulaCov19 mRNA vaccine is well tolerated, elicited strong SARS-CoV-2-specific B- and T-cell immunogenicity, and is currently under phase 2 and later clinical development.

“ChulaCov19 mRNA vaccine is well tolerated, elicited strong SARS-CoV-2-specific B-and T-cell immunogenicity, and is currently under phase 2 and later clinical development.”

May combine two claims.

Most reactions were mild to moderate and transient, with mean duration of 1.97 ± 1.2 d in adults and 1.39 ± 0.5 d in the elderly after Dose 2.

“Most reactions were mild to moderate and transient, with mean duration of 1.97 ± 1.2 d in adults and 1.39 ± 0.5 d in the elderly after Dose 2 (Fig. 1).”

May combine two claims.

Its incidence was dose-dependent, more common in adults than the elderly, and after Dose 2.

“Its incidence was dose-dependent, more common in adults than the elderly, and after Dose 2.”

May combine two claims.

In the adult cohort, at 1 week after dose 2, the 50 μg dose elicited psVNT-50 GMTs against Alpha, Beta and Gamma variants at ratios that were 4.5, 11.9 and 4.2, respectively, which are higher than those of the Pfizer/BNT vaccine (P < 0.01).

“In the adult cohort, at 1 week after dose 2, the 50 μg dose elicited psVNT-50 GMTs against Alpha, Beta and Gamma variants at ratios that were 4.5, 11.9 and 4.2, respectively, which are higher than those of the Pfizer/BNT vaccine (P < 0.01).”

May combine two claims.

All local reactions were mild in the elderly; some moderate events occurred in adults.

“All local reactions were mild in the elderly; some moderate events occurred in adults.”

May combine two claims.

ChulaCov19 at 50 μg dose induced high SARS-CoV-2 binding and neutralizing antibodies 1 week after dose 2 (P < 0.01), with a microVNT-50 GMT 6-fold higher than those of HCS.

“ChulaCov19 at 50 μg dose induced high SARS-CoV-2binding and neutralizing antibodies 1 week after dose 2 (P < 0.01), with a microVNT-50 GMT 6-fold higher than those of HCS.”

May combine two claims.

Systemic reactions were more common at the 25 μg and 50 μg doses, after Dose 2, and in adults.

“Systemic reactions were more common at the 25 μg and 50 μg doses, after Dose 2, and in adults.”

May combine two claims.

The mRNA vaccine expressing a prefusion non-stabilized spike protein is safe and highly immunogenic.

“We conclude that the mRNA vaccine expressing a prefusion non-stabilized spike protein is safe and highly immunogenic.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The changes after 6 months at 2-8 °C were minimal and would not be expected to have any impact on the functionality of the LNP (although this was not tested).

“where specifications are not set, the changes were minimal and would not be expected to have any impact on the functionality of the LNP (although note that this was not tested).”

• AssumptionThe authors state this as an assumption: The changes in LNP parameters after 6 months at 2-8 °C would not impact the functionality of the LNP.

Probably not a substantial claim: may not pass S3 (load-bearing).

All participants meeting eligibility criteria were randomized sequentially in a 1:1:1 allocation ratio into each dose schedule.

“All participants meeting eligibility criteria were randomized sequentially in a 1:1:1 allocation ratio into each dose schedule.”

• Also stated in: § Additional information · plain

  “All participants meeting eligibility criteria were randomized sequentially in a 1:1:1 allocation ratio into each dose schedule.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The recruitment and screening processes did not lead to enrollment biases, although participants who did not know about the study may have had less opportunity to participate.

“These processes therefore did not led themselves to enrollment biases however participants who did not know about the study may have had less of an opportunity to participate.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Eligible participants were randomized to vaccine dose level in a blinded manner.

“Eligible participants were then randomized to vaccine dose level in a blinded manner.”

May combine two claims.

The exploratory comparative immunogenicity analyses with convalescent sera or Pfizer/BNT vaccinees' sera are not head-to-head comparisons and are not free from bias.

“The exploratory comparative immunogenicity analyses with convalescent sera or Pfizer/BNT vaccinees' sera are not head-to-head comparisons and are not free from bias.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

Convalescent sera were collected during the Delta wave in Thailand, and it is possible that human convalescent sera antibody responses are stronger against Delta than against WT.

“Convalescent sera were collected during the Delta wave in Thailand, and it is possible that human convalescent sera antibody responses are stronger against Delta than against WT.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In the adult and elderly cohorts, body mass index was 23 (2.8) and 23.3 (3.3), respectively.

“Mean age (SD) in the adult and elderly cohorts was 35.8(9.1) and 65.1(5.4)years, respectively; body mass index was 23(2.8) and 23.3(3.3);and proportion of females was 67% and 53%.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Sample size for phase I was based on practical and medical considerations rather than power for statistical hypothesis testing or precision of parameter estimation.

“Sample size for phase I was based on practical and medical considerations rather than power for statistical hypothesis testing or precision of parameter estimation.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

This participant was excluded from the per protocol immunogenicity analysis, as were two others: one participant from the adult 10 μg group who was diagnosed with asymptomatic COVID-19 on the sixth day after the second vaccination and one participant from the adult 50 μg group who had confirmed positive baseline anti-RBD binding antibody test but was negative for SARS-CoV-2 molecular testing,indic

“This participant was excluded from the per protocol immunogenicity analysis, as were two others: one participant from the adult 10 μg group who was diagnosed with asymptomatic COVID-19 on the sixth day after the second vaccination and one participant from the adult 50 μg group who had confirmed positive baseline anti-receptor binding domain (RBD) binding antibody test but was negative for SARS-CoV”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In the adult and elderly cohorts, the proportion of females was 67% and 53%, respectively.

“Mean age (SD) in the adult and elderly cohorts was 35.8(9.1) and 65.1(5.4)years, respectively; body mass index was 23(2.8) and 23.3(3.3);and proportion of females was 67% and 53%.”

Probably not a substantial claim: may not pass S2 (checkable).

It is likely that dual vaccinations with ChulaCov19 vaccine may need a third booster dose, ideally with a second-generation vaccine.

“It is therefore likely that dual vaccinations with ChulaCov19 vaccine may need a third booster dose, ideally with a second-generation vaccine.”

Probably not a substantial claim: may not pass S3 (load-bearing).

All participants provided written informed consent.

“All participants provided written informed consent.”

May combine two claims.

We provide presumably the first evidence in humans that an mRNA vaccine expressing a prefusion non-stabilized spike protein is safe and highly immunogenic, similar to an approved mRNA vaccine, Pfizer/BNT, expressing a prefusion spike protein stabilized by the addition of a di-proline mutation.

“In summary, we provide presumably the first evidence in humans that an mRNA vaccine expressing a prefusion non-stabilized spike protein is safe and highly immunogenic, similar to an approved mRNA vaccine, Pfizer/BNT, expressing a prefusion spike protein stabilized by the addition of a di-proline mutation.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

This was an open label study, no blinding.

“This was an open label study, no blinding.”

Probably not a substantial claim: may not pass S3 (load-bearing).

To minimize bias, the convalescent and Pfizer/BNT vaccinees' serum samples were tested at the same laboratories together with the ChulaCov19 vaccinated samples.

“To minimize bias, the convalescent and Pfizer/ BNT vaccinees' serum samples were tested at the same laboratories together with the ChulaCov19 vaccinated samples.”

May combine two claims.

ChulaCov19 induced strong binding and neutralizing antibody responses 4 weeks after the second dose, and the ratio of neutralizing antibody GMT in ChulaCov19 vaccinees vs convalescent sera of 4 weeks after diagnosis of approximately 4-8-fold suggests that this vaccine candidate has a potentially significant vaccine efficacy.

“Chu-laCov19 induced strong binding and neutralizing antibody responses 4 weeks after the second dose, and the ratio of neutralizing antibody GMT in ChulaCov19 vaccinees vs convalescent sera of 4 weeks after diagnosis of approximately 4-8-fold suggests that this vaccine candidate has a potentially significant vaccine efficacy.”

Probably not a substantial claim: may not pass S3 (load-bearing).

All participants in the elderly cohort received two doses of the ChulaCov19 vaccine.

“All the participants received two doses of the ChulaCov19 vaccine.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Study participants were recruited at one site.

“Study participants were recruited at the one site.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The limitations of this study include the small sample size and dose-finding design.

“The limitations of this study include the small sample size and dose-finding design.”

Probably not a substantial claim: may not pass S3 (load-bearing).

All participants contributed to the safety analysis.

“All participants contributed to the safety analysis.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The trial and the Investigational New Drug application were approved by the ethics committee of the Faculty of Medicine, Chulalongkorn University, Bangkok, and Thailand's Food and Drug Administration.

“The trial and the Investigational New Drug application were approved by the ethics committee of the Faculty of Medicine, Chulalongkorn University, Bangkok, and Thailand's Food and Drug Administration, respectively”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

The trial and the Investigational New Drug application were approved by the ethics committee of the Faculty of Medicine, Chulalongkorn University, Bangkok, and Thailand's Food and Drug Administration, respectively.

“The trial and the Investigational New Drug application were approved by the ethics committee of the Faculty of Medicine, Chulalongkorn University, Bangkok, and Thailand's Food and Drug Administration, respectively.”

Probably not a substantial claim: may not pass S3 (load-bearing).

There was no attempt at replication of study findings.

“There was no attempt at replication of study findings.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

In the adult and elderly cohorts, mean age (SD) was 35.8 (9.1) and 65.1 (5.4) years, respectively.

“Mean age (SD) in the adult and elderly cohorts was 35.8(9.1) and 65.1(5.4)years, respectively; body mass index was 23(2.8) and 23.3(3.3);and proportion of females was 67% and 53%.”

Probably not a substantial claim: may not pass S3 (load-bearing).

All participants received two doses of the ChulaCov19 vaccine, except one participant assigned to 25 μg who received one dose.

“All the participants received two doses of the ChulaCov19 vaccine, except for one participant who was assigned to receive 25 μg of ChulaCov19, who received one dose.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Immunogenicity was analysed per protocol.

“Immunogenicity was analysed per protocol.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Sentinel dosing was performed in each dose-escalation cohort.

“Sentinel dosing was performed in each dose-escalation cohort.”

Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.

This spike protein consists of an extracellular domain with no transmembrane and cytoplasmic domains; therefore, it will be a secreted spike protein.

“This spike protein consists of an extracellular domain with no transmembrane and cytoplasmic domains; therefore, it will be a secreted spike protein.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Participant sera and PBMCs were tested as single measurement.

“Participant sera and PBMCs were tested as single measurement.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Mean ages in the adult and elderly cohorts were 35.8 and 65.1 years, respectively; body mass indices were 23 and 23.3, and proportions of females were 67% and 53%, respectively.

“Mean ages(s.d.) in the adult and elderly cohorts were 35.8 (9.1) and 65.1 (5.4) yr, respectively; body mass indices were 23 (2.8) and 23.3 (3.3), and proportions of females were 67% and 53%, respectively.”