Immunogenicity and Safety of a 3-Dose Regimen of a SARS-CoV-2 Inactivated Vaccine in Adults: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

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 mu g or 10 mu g 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. The severe acute respiratory syndrome 2 (SARS-CoV-2) inactivated vaccine (KCONVAC) induced robust immune response after 2 doses but showed limited boosting antibody response after the third dose administered 28 days after the second vaccination.

Automated summary

This study evaluated the efficacy and safety of a SARS-CoV-2 inactivated vaccine. The results showed that two doses of the vaccine induced a robust immune response and had a good safety profile. The third dose given 28 days after the second dose had limited boosting antibody response.