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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19; SARS-CoV-2 Infection
• Intervention / Treatment: Biological: SARS-CoV-2 Vaccine(Vero Cell), Inactivated

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 Type: Observational
• Enrollment (Anticipated): 1370

Contacts and Locations

• Study Contact: Name: ZhiTao YANG; Phone Number: +8613611965436; Email: yangzhitao@hotmail.fr
• Study Contact Backup: Name: Xiaoqi Yu; Phone Number: +8613817390935; Email: yuxiaoqi_03@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Contact: ZhiTao YANG; Phone Number: +8613611965436; Email: yangzhitao@hotmail.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Medical workers in Ruijin Hospital who are willing to receive two dose of SARS-CoV-2 inactivated vaccine via intramuscular injection in the arm

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaccination Group; Participants vaccinated with inactivated SARS-CoV-2 vaccine are studied for safety and antibody response.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants reporting local reactions	Pain at the injection site, swelling, itch, and redness	within 7days post each vaccination
Percentage of participants reporting systemic events	Fever, headache, fatigue, nausea, vomiting, diarrhea, constipation, myalgia, arthralgia	within 7days post each vaccination
Percentage of participants reporting adverse events	verified by investigators	From Dose 1 through 1 month after Dose 2
Percentage of participants reporting serious adverse events	verified by investigators	From Dose 1 through 1 month after Dose 2
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Director: Erzhen Chen, Ruijin Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2021
• Primary Completion (ANTICIPATED): April 30, 2022
• Study Completion (ANTICIPATED): January 31, 2023

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (ACTUAL): March 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 19, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Covid19; Inactivated vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RJHKY2021-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No