NCT04795414

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,370 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• SARS-CoV-2 Infection
• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	SARS-CoV-2 Vaccine(Vero Cell), Inactivated	The subjects of Vaccination Group will receive two doses, 21 days apart of inactivated SARS-CoV-2 vaccine (4 μg of BBIBP-CorV)

Timeline

• Start date: 2021-01-14
• Primary completion: 2022-04-30
• Completion: 2023-01-31
• First posted: 2021-03-12
• Last updated: 2021-03-19

Locations

1 site across 1 country: China