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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04795414
• Other study ID #: RJHKY2021-12
• Status: Recruiting
• Start date: January 14, 2021
• Est. completion date: January 31, 2023

Study information

• Verified date: March 2021
• Source: Ruijin Hospital
• Contact: ZhiTao Yang
• Phone: +8613611965436
• Email: yangzhitao[@]hotmail.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1370
• Est. completion date: January 31, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• SARS-CoV-2 Infection

Intervention

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)

Locations

Country	Name	City	State
China	Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants reporting local reactions	Pain at the injection site, swelling, itch, and redness	within 7days post each vaccination
Primary	Percentage of participants reporting systemic events	Fever, headache, fatigue, nausea, vomiting, diarrhea, constipation, myalgia, arthralgia	within 7days post each vaccination
Primary	Percentage of participants reporting adverse events	verified by investigators	From Dose 1 through 1 month after Dose 2
Primary	Percentage of participants reporting serious adverse events	verified by investigators	From Dose 1 through 1 month after Dose 2
Primary	Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres	determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels	at 1 month after dose 2
Secondary	Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres	determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels	at 6 months after dose 2
Secondary	Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres	determination of anti-SARS-CoV-2 speicfic antibody and SARS-CoV-2 neutralizing antibody levels	at 12 months after dose 2