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Inactivated SARS-CoV-2 Vaccine Well Tolerated in Phase 1/2 Trial

MONDAY, Oct. 19, 2020 -- An inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine seems safe and induces humoral responses, according to a study published online Oct. 15 in The Lancet Infectious Diseases.

Shengli Xia, from the Henan Provincial Center for Disease Control and Prevention in China, and colleagues conducted a phase 1/2 trial to assess the inactivated SARS-CoV-2 vaccine candidate BBIBP-CorV. A total of 192 healthy people aged 18 to 80 years were randomly assigned to receive either vaccine or placebo in a two-dose schedule in phase 1 (2, 4, or 8 µg on days 0 and 28). In phase 2, 448 healthy adults aged 18 to 59 years were randomly assigned to receive either vaccine or placebo on a single-dose schedule of 8 µg on day 0 or a two-dose schedule of 4 µg on days 0 and 14, 0 and 21, or 0 and 28.

The researchers identified at least one adverse reaction within seven days of inoculation in 29 percent of vaccine recipients in phase 1. Fever was the most common systematic adverse reaction; all adverse reactions were mild or moderate. Compared with the placebo group, the neutralizing antibody geometric mean titers were higher at day 42 in the vaccine groups aged 18 to 59 years and 60 years or older. In phase 2, 23 percent of vaccine recipients reported at least one adverse reaction within seven days. Fever was the most common systematic adverse reaction; all other adverse reactions were mild or moderate. On day 28, the vaccine-elicited neutralizing antibody titers were significantly greater in the two-dose schedules than the single-dose schedule.

"We found that the inactivated SARS-CoV-2 vaccine BBIBP-CorV is tolerable and immunogenic in healthy people," the authors write.

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Posted: October 2020

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