Study outcomes
ADVERSE REACTIONS
The primary outcomes were the immunogenicity and safety of the booster vaccination of NVSI-06-09 against SARS-CoV-2 Omicron variant, in comparison with the boost of BBIBP-CorV, on day 14 after the vaccination. The immunogenicity was evaluated by the geometric mean titers (GMTs) of anti-Omicron neutralizing antibodies (nAbs), and the four-fold rise rate of the neutralizing GMTs from baseline. Anti-Omicron nAb titers were measured by live-virus microneutralization assays. The safety was assessed by occurrence and severity of adverse reactions. NVSI-06-09 was designed as a potential broad-spectrum COVID-19 vaccine. To assess the broad immune responses induced by a booster dose of NVSI-06-09, the cross-neutralizing antibody GMTs against other SARS-CoV-2 strains, including the prototype, Beta and Delta, were also detected as an exploratory study.