TY - JOUR T1 - Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults. AU - Mulligan,Mark J, AU - Lyke,Kirsten E, AU - Kitchin,Nicholas, AU - Absalon,Judith, AU - Gurtman,Alejandra, AU - Lockhart,Stephen, AU - Neuzil,Kathleen, AU - Raabe,Vanessa, AU - Bailey,Ruth, AU - Swanson,Kena A, AU - Li,Ping, AU - Koury,Kenneth, AU - Kalina,Warren, AU - Cooper,David, AU - Fontes-Garfias,Camila, AU - Shi,Pei-Yong, AU - Türeci,Özlem, AU - Tompkins,Kristin R, AU - Walsh,Edward E, AU - Frenck,Robert, AU - Falsey,Ann R, AU - Dormitzer,Philip R, AU - Gruber,William C, AU - Şahin,Uğur, AU - Jansen,Kathrin U, Y1 - 2020/08/12/ PY - 2020/06/29/received PY - 2020/08/04/accepted PY - 2020/8/14/entrez JF - Nature JO - Nature N2 - In March 2020, the World Health Organization (WHO) declared a pandemic of coronavirus disease 2019 (COVID-19), due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1. With rapidly accumulating cases and deaths reported globally2, a vaccine is urgently needed. We report the available safety, tolerability, and immunogenicity data from an ongoing placebo-controlled, observer-blinded dose escalation study among 45 healthy adults, 18 to 55 years of age, randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, a lipid nanoparticle-formulated, nucleoside-modified mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD). Local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A second vaccination with 100 µg was not administered due to increased reactogenicity and a lack of meaningfully increased immunogenicity after a single dose compared to the 30 μg dose. RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titers in sera increased with dose level and after a second dose. Geometric mean neutralizing titers reached 1.9- to 4.6-fold that of a panel of COVID-19 convalescent human sera at least 14 days after a positive SARS-CoV-2 PCR. These results support further evaluation of this mRNA vaccine candidate. (ClinicalTrials.gov identifier: NCT04368728). SN - 1476-4687 UR - https://www.unboundmedicine.com/medline/citation/32785213/full_citation L2 - https://doi.org/10.1038/s41586-020-2639-4 DB - PRIME DP - Unbound Medicine ER -