Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial
Open accessAbstract
Background A vaccine to protect against COVID-19 is urgently needed. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 (Ad5) vectored COVID-19 vaccine expressing the spike glycoprotein of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strain.Methods We did a dose-escalation, single-centre, open-label, non-randomised, phase 1 trial of an Ad5 vectored COVID-19 vaccine in Wuhan, China. Healthy adults aged between 18 and 60 years were sequentially enrolled and allocated to one of three dose groups (5 × 10 10, 1 × 10 11, and 1·5 × 10 11 viral particles) to receive an intramuscular injection of vaccine. The primary outcome was adverse events in the 7 days post-vaccination. Safety was assessed over 28 days post-vaccination. Specific antibodies were measured with ELISA, and the neutralising antibody responses induced by vaccination were detected with SARS-CoV-2 virus neutralisation and pseudovirus neutralisation tests. T-cell responses were assessed by enzyme-linked immunospot and flow-cytometry assays. This study is registered with ClinicalTrials.gov, NCT04313127.Findings Between March 16 and March 27, 2020, we screened 195 individuals for eligibility. Of them, 108 participants (51% male, 49% female; mean age 36·3 years) were recruited and received the low dose (n=36), middle dose (n=36), or high dose (n=36) of the vaccine. All enrolled participants were included in the analysis. At least one adverse reaction within the first 7 days after the vaccination was reported in 30 (83%) participants in the low dose group, 30 (83%) participants in the middle dose group, and 27 (75%) participants in the high dose group. The most common injection site adverse reaction was pain, which was reported in 58 (54%) vaccine recipients, and the most commonly reported systematic adverse reactions were fever (50 [46%]), fatigue (47 [44%]), headache (42 [39%]), and muscle pain (18 [17%]. Most adverse reactions that were reported in all dose groups were mild or moderate in severity. No serious adverse event was noted within 28 days post-vaccination. ELISA antibodies and neutralising antibodies increased significantly at day 14, and peaked 28 days post-vaccination. Specific T-cell response peaked at day 14 post-vaccination.Interpretation The Ad5 vectored COVID-19 vaccine is tolerable and immunogenic at 28 days post-vaccination. Humoral responses against SARS-CoV-2 peaked at day 28 post-vaccination in healthy adults, and rapid specific T-cell responses were noted from day 14 post-vaccination. Our findings suggest that the Ad5 vectored COVID-19 vaccine warrants further investigation.Funding National Key R&D Program of China, National Science and Technology Major Project, and CanSino Biologics.
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In phase 1 trials, mRNA-based vaccines (ARCoV, BNT162b1) and adenovirus-vector vaccines (ChAdOx1, Ad5 vectored COVID-19 vaccine) induced a strong T-helper-1-cell response in most participants.
“In phase 1 trials, mRNA-based vaccines (ARCoV, BNT162b1)16 and adenovirus-vector vaccines (ChAdOx1,25 Ad5 vectored COVID-19 vaccine)26 induced a strong T-helper-1-cell response in most participants.”
From Safety and immunogenicity of the SARS-CoV-2 ARCoV mRNA vaccine in Chinese adults: a randomised, double-blind, placebo-controlled, phase 1 trial (2022) · cites this paper as [26]
The Results report positive T-cell responses in 83–97% of participants across Ad5 vaccine dose groups and detect IFNγ, TNFα, and IL-2 from CD4+ T cells. The paper does not establish that a strong T-helper-1-specific response occurred in most participants; its responder percentages are for T-cell responses more generally. Citation 26 applies to the Ad5 vaccine, not the other vaccines listed in the sentence. (LLM, conf=0.84)
Experimental — accuracy not yet measuredThe S glycoprotein is the primary vaccine target for many candidate SARS-CoV-2 vaccines.
“The S glycoprotein mediates host cell attachment and is required for viral entry3; it is the primary vaccine target for many candidate SARS-CoV-2 vaccines.4-7”
From An mRNA Vaccine against SARS-CoV-2 — Preliminary Report (2020) · cites this paper as [5]
In animal models of other coronaviruses and prior inactivated RSV or measles vaccines, VAERD is usually linked to Th2-biased CD4+ responses with elevated IL-4, IL-5, or IL-13.
“In animal models of infections with other coronaviruses and for previous whole-cell inactivated vaccines developed for respiratory syncytial virus and measles virus, VAERD has usually been associated with the development of T helper 2 cell (TH2 cell)-biased CD4+ T cell responses, with significantly increased levels of interleukin-4 (IL-4), IL-5 and/or IL-13 (refs12,126,165–174).”
From Immunological mechanisms of vaccine-induced protection against COVID-19 in humans (2021) · cites this paper as [12]
Gam-COVID-Vac uses different adenovirus vectors for each dose, which circumvents anti-vector immunity that could inhibit anti-S responses, as seen with Ad5-nCoV and non-COVID-19 adenovirus-based vaccines.
“This may be, in part, due to the fact that Gam-COVID-Vac uses different adenovirus vectors for each dose (adenovirus 26 for dose one and adenovirus 5 for dose two), thus circumventing the potential problem of anti-vector immunity that could inhibit anti-S responses, as has been identified for Ad5-nCoV (refs12,91) (Table 1) and non-COVID-19 adenovirus-based vaccines92.”
From Immunological mechanisms of vaccine-induced protection against COVID-19 in humans (2021) · cites this paper as [12]
Long-term homologous prime-boost with identical viral-vectored vaccines may be limited by anti-vector immunity.
“In the long term, a strategy involving homologous prime–boost with identical viral-vectored vaccines may be limited by anti-vector immunity12,91,92.”
From Immunological mechanisms of vaccine-induced protection against COVID-19 in humans (2021) · cites this paper as [12]
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- Authors
- Zhu, F.-C., Li, Y.-H., Guan, X.-H., Hou, L.-H., Wang, W.-J., Li, J.-X., Wu, S.-P., Wang, B.-S., Wang, Z., Wang, L., Jia, S.-Y., Jiang, H.-D., Wang, L., Jiang, T., Hu, Y., Gou, J.-B., Xu, S.-B., Xu, J.-J., Wang, X.-W., Wang, W., & Chen, W.
- Affiliations
- National Institutes for Food and Drug Control (CN)
- Hubei Provincial Center for Disease Control and Prevention (CN)
- Jiangsu Provincial Center for Disease Control and Prevention (CN)
- Beijing Institute of Microbiology and Epidemiology (CN)
- CanSino (China) (CN)
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2020-06
- Volume
- 395
- Issue
- 10240
- Pages
- 1845-1854
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC7255193
- OpenAlex
- W3027138240
- Cited by
- 1,382
- References
- 34
- Citations by year
- 2026: 16 · 2025: 66 · 2024: 94 · 2023: 138 · 2022: 261 · 2021: 447 · 2020: 358 · 2019: 1
- FWCI
- 39.44
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The Lancet (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Tongji University
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Virus-based gene therapy research
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Keywords
- SARS-CoV-2 spike protein, COVID-19 vaccines, vaccine safety, vaccine tolerability, immunogenicity, dose escalation, neutralizing antibodies, T cell response, adverse events, intramuscular injection
- MeSH terms
- Betacoronavirus, COVID-19, SARS-CoV-2, COVID-19 Vaccines, Adenoviridae, Adolescent, Adult, Antibodies, Viral, China, Enzyme-Linked Immunosorbent Assay, Female, Humans, Immunity, Cellular, Injections, Intramuscular, Male, Middle Aged, Pneumonia, Viral, T-Lymphocytes, Vaccines, Synthetic, Viral Vaccines, Coronavirus Infections, Young Adult, Immunity, Humoral, Antibodies, Neutralizing, Pandemics
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.
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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