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

• Conditions: Covid19; SARS-CoV-2 Infection
• Interventions: Biological: SARS-CoV-2 Vaccine(Vero Cell), Inactivated

• Registration Number: NCT04795414
• Lead Sponsor: Ruijin Hospital

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.

Study Timeline

• Study Start: 2021-01-14
• Status Verified: 2021-03
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-12
• Last Update Submitted: 2021-03-17
• Last Update Posted: 2021-03-19
• Primary Completion: 2022-04-30
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1370

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vaccination Group	SARS-CoV-2 Vaccine(Vero Cell), Inactivated	Participants vaccinated with inactivated SARS-CoV-2 vaccine are studied for safety and antibody response.

Primary Outcome Measures

Name	Time	Method
Percentage of participants reporting local reactions	within 7days post each vaccination	Pain at the injection site, swelling, itch, and redness
Percentage of participants reporting systemic events	within 7days post each vaccination	Fever, headache, fatigue, nausea, vomiting, diarrhea, constipation, myalgia, arthralgia
Percentage of participants reporting adverse events	From Dose 1 through 1 month after Dose 2	verified by investigators
Percentage of participants reporting serious adverse events	From Dose 1 through 1 month after Dose 2	verified by investigators
Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres	at 1 month after dose 2	determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels

Secondary Outcome Measures

Name	Time	Method
Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres	at 12 months after dose 2	determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels

Trial Locations

Locations (1)

Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China