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