Safety and Immunogenicity of an Inactivated Vaccine Against COVID-19 in Medical Workers

Summary

Participation Requirements

Description

1370 participants who were negative for serum-specific antibodies against SARS-CoV-2 at the time of screening were enrolled and were receive a two-dose schedule, 21 days apart, with 4 ?g BBIBP-CorV inactivated SARS-CoV-2 vaccine. The primary safety outcome includes solicited local and systemic react...

1370 participants who were negative for serum-specific antibodies against SARS-CoV-2 at the time of screening were enrolled and were receive a two-dose schedule, 21 days apart, with 4 ?g BBIBP-CorV inactivated SARS-CoV-2 vaccine. The primary safety outcome includes solicited local and systemic reactions prompted by and recorded in an electronic diary within 7 days post each injection, unsolicited adverse events and serious adverse events assessed from the receipt of each dose, and clinical laboratory abnormalities from dose 1 through 1month after dose 2. Laboratory tests included measurement of alanine aminotransferase, aspartate aminotransferase, serum total bilirubin, serum albumin, creatinine, blood urea nitrogen, and blood routine examination. Immunogenicity was assessed as the serum anti-SARS-CoV-2 specific antibody responses and neutralizing activity at 4 weeks after the second vaccination.

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