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

NCT ID: NCT04795414

Last Updated: 2021-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1370 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-14
• Study Completion Date: 2023-01-31

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.

Conditions

SARS-CoV-2 Infection; Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Vaccination Group

Participants vaccinated with inactivated SARS-CoV-2 vaccine are studied for safety and antibody response.

SARS-CoV-2 Vaccine(Vero Cell), Inactivated

Intervention Type: BIOLOGICAL

The subjects of Vaccination Group will receive two doses, 21 days apart of inactivated SARS-CoV-2 vaccine (4 μg of BBIBP-CorV)

Interventions

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)

Intervention Type: BIOLOGICAL

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

• NA

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erzhen Chen

Role: STUDY_DIRECTOR

Ruijin Hospital

Xinxin Zhang

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

ZhiTao Yang

Role: CONTACT

yangzhitao@hotmail.fr

+8613611965436

Xiaoqi Yu

Role: CONTACT

yuxiaoqi_03@163.com

+8613817390935

Facility Contacts

ZhiTao YANG

Role: primary

yangzhitao@hotmail.fr

+8613611965436

References

Yu X, Wei D, Xu W, Liu C, Guo W, Li X, Tan W, Liu L, Zhang X, Qu J, Yang Z, Chen E. Neutralizing activity of BBIBP-CorV vaccine-elicited sera against Beta, Delta and other SARS-CoV-2 variants of concern. Nat Commun. 2022 Apr 4;13(1):1788. doi: 10.1038/s41467-022-29477-0.

Reference Type: DERIVED

PMID: 35379815 (View on PubMed)

Other Identifiers

RJHKY2021-12

Identifier Type: -

Identifier Source: org_study_id