Alliance for Pandemic Preparedness

October 15, 2020

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial

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  • In a randomized placebo-controlled phase 1/2 trial of a SARS-CoV-2 vaccine candidate, BBIBP-CorV, 192 healthy adults were randomized to receive vaccine (2, 4, or 8 μg) or placebo in a 3:1 ratio, stratified by age (18-59 and ≥60) in phase 1. Adverse reactions within the first 7 days of inoculation were reported by 42 (29%) of 144 vaccine recipients; all were mild or moderate. Neutralizing antibody titers were higher at day 42 among 18-59 year-olds than those ≥60, and demonstrated a dose response. In phase 2, 448 were randomized to receive a single 8 μg injection or two 4 μg injections. All adverse reactions remained mild or moderate. Neutralizing antibody titers were significantly higher on day 28 among all two-dose 4 μg schedules than the single 8 μg dose (p<0.0001).

Xia et al. (Oct 15, 2020). Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. The Lancet Infectious Diseases. https://doi.org/10.1016/S1473-3099(20)30831-8