Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults

Summary

This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: * As 2 doses, separated by 21 days * At a single dose level * In adults 20 to 85 years of age

Timeline

Start

2020-10-21

Primary completion

2021-11-25

Completion

2021-11-25

Publications

• Haranaka M, Baber J, Ogama Y, Yamaji M, Aizawa M, Kogawara O, Scully I, Lagkadinou E, Tureci Ӧ, Sahin U, Dormitzer PR, Gruber WC, Lockhart S. A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults. Nat Commun. 2021 Dec 14;12(1):7105. doi: 10.1038/s41467-021-27316-2.

Drugs

Indications