March 9, 2021

Safety and Immunogenicity of an Inactivated SARS-CoV-2 Vaccine, BBV152: Interim Results from a Double-Blind, Randomised, Multicentre, Phase 2 Trial, and 3-Month Follow-up of a Double-Blind, Randomised Phase 1 Trial

Category: Article Summary

Topic: Vaccines and Immunity

Keywords (Tags): vaccines

• Interim results from a double-blind randomized phase 2 trial (n=380) of the Bharat Biotech whole-virion inactivated SARS-CoV-2 vaccine (BBV152) show robust neutralizing titers against wild-type SARS-CoV-2 at day 56 following two doses administered on day 0 and day 28. In a plaque-reduction neutralization test, the 6 µg dose group compared to the 3 µg dose group had higher geometric mean neutralizing titers (197 vs 100) and higher proportion of seroconversion (98% vs 93%) at day 56. No significant difference was observed in the proportion of participants who reported local or systematic adverse reactions between the dose groups (20% vs 21%), and no serious adverse events were reported in the study.

Ella et al. (Mar 8, 2021). Safety and Immunogenicity of an Inactivated SARS-CoV-2 Vaccine, BBV152: Interim Results from a Double-Blind, Randomised, Multicentre, Phase 2 Trial, and 3-Month Follow-up of a Double-Blind, Randomised Phase 1 Trial. The Lancet Infectious Diseases. https://doi.org/10.1016/S1473-3099(21)00070-0