Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults

August 12, 2020

Mulligan M, Lyke K, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Vanessa Raabe, Bailey R, Swanson K, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi P, Türeci Ö, Tompkins K, Walsh E, Frenck R, Falsey A, Dormitzer P, Gruber W, Sahin U & Jansen K

Nature

BNT162b1 is a nucleoside-modified mRNA vaccine formulated with lipid nanoparticles that encode the trimerized receptor-binding domain (RBD) of the SARS-CoV-2 peak glycoprotein. This article reports the safety, tolerability, and immunogenicity data obtained from an ongoing placebo-control, dose-escalation, and observer-blind study that included 45 healthy adults (18-55 years), randomized to receive 2 doses, separated by 21 days, 10 µg, 30 µg or 100 µg of BNT162b1. Local reactions and systemic events to the vaccine were found to be dose-dependent, mostly mild or moderate, and transient. A second 100 μg dose was not administered due to increased reactogenicity and lack of significant increase in immunogenicity compared to the first 30 μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in serum increased with the first and second doses. The geometric mean of neutralizing titers was 1.9 to 4.6 times higher than a panel of COVID-19 convalescent human sera, obtained 14 days after a positive PCR for SARS-CoV-2. These results support further evaluation of this mRNA vaccine candidate. However, the limitations of this study include the lack of time to follow-up the participants (it will continue for at least 6 months), in addition to the lack of inclusion of a population at high risk for severe disease due to COVID-19.

Mulligan M, Lyke K, Kitchin N, Absalon J, Gurtman A, Lockhart S, Neuzil K, Vanessa Raabe, Bailey R, Swanson K, Li P, Koury K, Kalina W, Cooper D, Fontes-Garfias C, Shi P, Türeci Ö, Tompkins K, Walsh E, Frenck R, Falsey A, Dormitzer P, Gruber W, Sahin U & Jansen K. Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. Doi: 10.1038/s41586-020-2639-4

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