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

摘要: In March 2020, the World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), which is caused by severe acute respiratory syndrome 2 (SARS-CoV-2)1, a pandemic. With rapidly accumulating numbers of cases and deaths reported globally2, vaccine urgently needed. Here we report available safety, tolerability immunogenicity data from an ongoing placebo-controlled, observer-blinded dose-escalation study (ClinicalTrials.gov identifier NCT04368728) among 45 healthy adults (18–55 years age), who were randomized to receive doses—separated 21 days—of 10 μg, 30 μg or 100 μg BNT162b1. BNT162b1 lipid-nanoparticle-formulated, nucleoside-modified mRNA that encodes trimerized receptor-binding domain (RBD) spike glycoprotein SARS-CoV-2. Local reactions systemic events dose-dependent, generally mild moderate, transient. A second vaccination with was not administered because increased reactogenicity lack meaningfully after single dose compared 30-μg dose. RBD-binding IgG concentrations SARS-CoV-2 neutralizing titres in sera level Geometric mean reached 1.9–4.6-fold panel COVID-19 convalescent human sera, obtained at least 14 days positive PCR. These results support further evaluation this candidate. RNA 45 healthy adults,