Alliance for Pandemic Preparedness

November 18, 2020

Safety, Tolerability, and Immunogenicity of an Inactivated SARS-CoV-2 Vaccine in Healthy Adults Aged 18-59 Years: A Randomised, Double-Blind, Placebo-Controlled, Phase 1/2 Clinical Trial

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An inactivated vaccine produced by Sinovac was safe and immunogenic in early phase clinical testing. In a randomized, double-blind, placebo-controlled, phase 1/2 clinical trial (n=743), healthy adults who received two doses of a b-proprionolactione inactivated SARS-CoV2 vaccine (“CoronaVac”) demonstrated high rates of seroconversion. In phase 1 (n=143), the seroconversion rate after day 28 was 83% (3 ucg “low” dose) and 79% (6 ucg “high” dose) vs. 4% (placebo). In phase 2 (n=600), the seroconversion rate was 97% (low dose) and 100% (high dose) vs. 0% (placebo) after two doses. Both the low and high dose were well tolerated, with similar incidences of systemic adverse reactions when compared to placebo. Neutralizing titers were higher after two doses in the high dose group.

Zhang et al. (Nov 18, 2020). Safety, Tolerability, and Immunogenicity of an Inactivated SARS-CoV-2 Vaccine in Healthy Adults Aged 18-59 Years: A Randomised, Double-Blind, Placebo-Controlled, Phase 1/2 Clinical Trial. The Lancet Infectious Diseases. https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30843-4/fulltext