Safety and Immunogenicity of an Inactivated Vaccine Against COVID-19 in Medical Workers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- SARS-CoV-2 Infection
- Sponsor
- Ruijin Hospital
- Enrollment
- 1370
- Locations
- 1
- Primary Endpoint
- Percentage of participants reporting local reactions
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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
- Not provided
Outcomes
Primary Outcomes
Percentage of participants reporting local reactions
Time Frame: within 7days post each vaccination
Pain at the injection site, swelling, itch, and redness
Percentage of participants reporting systemic events
Time Frame: within 7days post each vaccination
Fever, headache, fatigue, nausea, vomiting, diarrhea, constipation, myalgia, arthralgia
Percentage of participants reporting adverse events
Time Frame: From Dose 1 through 1 month after Dose 2
verified by investigators
Percentage of participants reporting serious adverse events
Time Frame: From Dose 1 through 1 month after Dose 2
verified by investigators
Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres
Time Frame: at 1 month after dose 2
determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels
Secondary Outcomes
- Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres(at 12 months after dose 2)