Safety and Immunogenicity of an Inactivated Vaccine Against COVID-19 in Medical Workers
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About
With the unprecedented morbidity of the COVID-19 pandemic, the vaccine effectiveness needs to be assessed across diverse populations. The purpose of this study is to evaluate the safety and immunogenicity of an inactivated SARS-CoV-2 vaccine in medical workers.
Full 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 μg 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.
Enrollment
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Inclusion criteria
- Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
- Male or female aged 18-59 years.
Exclusion criteria
- NA
Trial design
1,370 participants in 1 patient group
Trial contacts and locations
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Central trial contact
ZhiTao Yang; Xiaoqi Yu
Data sourced from clinicaltrials.gov
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