Interim Results of a Phase 1-2a Trial of Ad26.COV2.S Covid-19 Vaccine
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View abstract on PubMed
Summary
This summary is machine-generated.The Ad26.COV2.S vaccine candidate demonstrated favorable safety and immunogenicity in adults. Neutralizing antibody titers were high after one dose, with further increases after a second dose, supporting its development for coronavirus disease 2019.
Area Of Science
- Vaccinology
- Immunology
- Infectious Diseases
Background
- Urgent need for effective vaccines against coronavirus disease 2019 (Covid-19) caused by SARS-CoV-2.
- Ad26.COV2.S is a candidate vaccine using a replication-incompetent adenovirus serotype 26 vector encoding the SARS-CoV-2 spike protein.
Purpose Of The Study
- To evaluate the safety and immunogenicity of the Ad26.COV2.S vaccine in healthy adults.
- To compare different doses and schedules (single vs. two-dose) of the Ad26.COV2.S vaccine.
Main Methods
- Phase 1-2a multicenter, placebo-controlled trial involving healthy adults aged 18-55 and ≥65 years.
- Participants received Ad26.COV2.S vaccine (low or high dose) or placebo in a single- or two-dose schedule.
- Primary endpoints included safety, reactogenicity, and immunogenicity (neutralizing and binding antibody titers, T-cell responses).
Main Results
- Common adverse events included fatigue, headache, myalgia, and injection-site pain; fever was the most frequent systemic event.
- High neutralizing antibody titers (≥90%) detected by day 29 after the first dose, with further increases after a second dose.
- Robust T-cell responses (CD4+ and CD8+) were observed, with a skew towards type 1 helper T cells.
Conclusions
- The Ad26.COV2.S vaccine exhibited promising safety and immunogenicity profiles.
- These findings support the further clinical development of Ad26.COV2.S as a Covid-19 vaccine candidate.
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