NCT04795414

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,370

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

March 11, 2021

Last Update Submit

March 17, 2021

Conditions

SARS-CoV-2 InfectionCovid19

Keywords

SARS-CoV-2Covid19Inactivated vaccine

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres

    at 6 months after dose 2

  • Serum anti-SARS-CoV-2 speicfic antibody and neutralizing antibody titres

    at 12 months after dose 2

Study Arms (1)

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

Interventions

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

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

Vaccination Group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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

You may qualify if:

  • Written informed consent according to ICH/GCP regulations prior to any trial specific procedures.
  • Male or female aged 18-59 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital affiliated to Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35379815DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample, including plasma, serum and blood cell

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Erzhen Chen

    Ruijin Hospital

    STUDY DIRECTOR

  • Xinxin Zhang

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ZhiTao Yang

CONTACT

+8613611965436yangzhitao@hotmail.fr

Xiaoqi Yu

CONTACT

+8613817390935yuxiaoqi_03@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

March 12, 2021

Study Start

January 14, 2021

Primary Completion

April 30, 2022

Study Completion

January 31, 2023

Last Updated

March 19, 2021

Record last verified: 2021-03

Locations

CN(1)