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

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    1370
  • sponsor
    Ruijin Hospital
Updated on 27 March 2021

Summary

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.

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 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.

Details
Condition COVID19, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection, SARS-CoV-2 Infection
Treatment SARS-CoV-2 Vaccine(Vero Cell), Inactivated
Clinical Study IdentifierNCT04795414
SponsorRuijin Hospital
Last Modified on27 March 2021

Eligibility

Yes No Not Sure

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
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