Abstract
An effective vaccine is needed to end the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Here, we assess the preliminary safety, tolerability and immunogenicity data from an ongoing single-center (in Jiangsu province, China), parallel-group, double-blind phase 1 trial of the vaccine candidate BNT162b1 in 144 healthy SARS-CoV-2-naive Chinese participants. These participants are randomized 1:1:1 to receive prime and boost vaccinations of 10 µg or 30 µg BNT162b1 or placebo, given 21 d apart, with equal allocation of younger (aged 18–55 years) and older adults (aged 65–85 years) to each treatment group (ChiCTR2000034825). BNT162b1 encodes the SARS-CoV-2 spike glycoprotein receptor-binding domain (RBD) and is one of several messenger RNA-based vaccine candidates under clinical investigation. Local reactions and systemic events were generally dose dependent, transient and mild to moderate. Fever was the only grade 3 adverse event. BNT162b1 induced robust interferon-γ T cell responses to a peptide pool including the RBD in both younger and older Chinese adults, and geometric mean neutralizing titers reached 2.1-fold (for younger participants) and 1.3-fold (for the older participants) that of a panel of COVID-19 convalescent human sera obtained at least 14 d after positive SARS-CoV-2 polymerase chain reaction test. In summary, BNT162b1 has an acceptable safety profile and produces high levels of humoral and T cell responses in an Asian population.
【초록키워드】 COVID-19, SARS-CoV-2, Vaccine, coronavirus, vaccination, pandemic, spike glycoprotein, BNT162b1, China, Randomized, Adults, RBD, response, adverse event, vaccine candidate, Mild, Placebo, convalescent, moderate, safety profile, Neutralizing titer, dose, double-blind, humoral, Asian, interferon-γ, acute respiratory syndrome, Older, Tolerability, Participants, domain, Chinese, single-center, treatment group, parallel-group, participant, phase 1 trial, immunogenicity data, human sera, clinical investigation, positive, ENCODE, local reaction, effective, event, polymerase chain, robust, Jiangsu, healthy, the RBD, reached, the vaccine, receive, geometric, peptide pool, prime and boost, the SARS-CoV-2, 【제목키워드】 Safety, mRNA vaccine, BNT162b1, Randomized, placebo-controlled, double-blind, phase 1 study, Older, Chinese, the SARS-CoV-2,