Abstract
Background: Control of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic needs effective vaccines.
Methods: In a phase 2 randomized, double-blind, placebo-controlled trial, 500 adults aged 18-59 years or ≥60 years were randomized in 2:2:1 ratio to receive 3 doses of 5 μg or 10 μg of a SARS-CoV-2 inactivated vaccine, or placebo separated by 28 days. Adverse events (AEs) were recorded through day 28 after each dosing. Live virus or pseudovirus neutralizing antibodies, and receptor binding domain immunoglobulin G (RBD-IgG) antibody were tested after the second and third doses.
Results: Two doses of the vaccine elicited geometric mean titers (GMTs) of 102-119, 170-176, and 1449-1617 for the 3 antibodies in younger adults. Pseudovirus neutralizing and RBD-IgG GMTs were similar between older and younger adults. The third dose slightly (<1.5 fold) increased GMTs. Seroconversion percentages were 94% or more after 2 doses, which were generally similar after 3 doses. The predominant AEs were injection-site pain. All the AEs were grade 1 or 2 in intensity. No serious AE was deemed related to study vaccination.
Conclusions: Two doses of this vaccine induced robust immune response and had good safety profile. A third dose given 28 days after the second dose elicited limited boosting antibody response.
Keywords: 3-dose regimen; SARS-CoV-2 inactivated vaccine; immunogenicity; safety.
【저자키워드】 immunogenicity, Safety, SARS-CoV-2 inactivated vaccine, 3-dose regimen, 【초록키워드】 SARS-CoV-2, Vaccine, coronavirus, immune response, vaccination, pandemic, Neutralizing antibodies, antibody, Antibody Response, virus, Receptor binding domain, Randomized, Adults, Immunoglobulin, Inactivated vaccine, pseudovirus, placebo-controlled trial, Control, Placebo, Neutralizing, safety profile, inactivated, dose, double-blind, intensity, acute respiratory syndrome, Older, Adverse, second dose, Effective vaccines, GMTs, doses, geometric mean titer, Injection-site pain, event, serious AE, robust, tested, the vaccine, predominant, elicited, separated, receive, were recorded, AEs, GMT, percentage, 【제목키워드】 SARS-CoV-2, Safety, Phase 2,