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Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
High-dosage of COVID-19 vaccine (Vero cell), Inactivated
Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated
Sponsored by
Sinovac Life Sciences Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy participants aged 18 years and above;
  • Proven legal identity;
  • The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
  • Have received two doses of inactivated COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research & Development Co., Ltd and that is currently 5-9 months after the second dose.

Exclusion Criteria:

  • History of SARS-CoV-2 infection(laboratory confirmed);
  • Have received three and more doses of inactivated COVID-19 vaccine;
  • Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
  • Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
  • Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;
  • Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
  • Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • History of alcohol or drug abuse;
  • Receipt of blood products within in the past 3 months;
  • Receipt of other investigational drugs in the past 30 days;
  • Receipt of attenuated live vaccines in the past 14 days;
  • Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
  • Axillary temperature >37.0°C;
  • Participated in other clinical trials prior to enrollment and during the followup period, or planned to participate in other clinical trials during the clinical trial period;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Sites / Locations

  • Beijing Youan Hospital Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated

Experimental Group-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated

Arm Description

170 participants will receive one dose of booster vaccination with high-dosage of COVID-19 vaccine (Vero cell), Inactivated.

170 participants will receive one dose of booster vaccination with medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.

Outcomes

Primary Outcome Measures

Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
GMT of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination

Secondary Outcome Measures

Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)
Seropositivity rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination

Full Information

First Posted
December 20, 2021
Last Updated
August 9, 2022
Sponsor
Sinovac Life Sciences Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05165966
Brief Title
Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19
Official Title
A Randomized, Double-Blinded Clinical Trial to Evaluate the Immunogenicity Using Additional Dose of Medium-dosage or High-dosage COVID-19 Vaccine (Vero Cell), Inactivated in Populations Who Have Completed Primary Immunization 5-9 Months
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2021 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
July 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Life Sciences Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months
Detailed Description
This study a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated.The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months.A total of 340 subjects who have completed primary immunization using two-dose Coronavac® 5-9 months were be enrolled.All of subjects were be randomly divided into two groups in a 1:1 ratio to receive high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
340 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated
Arm Type
Experimental
Arm Description
170 participants will receive one dose of booster vaccination with high-dosage of COVID-19 vaccine (Vero cell), Inactivated.
Arm Title
Experimental Group-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated
Arm Type
Experimental
Arm Description
170 participants will receive one dose of booster vaccination with medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.
Intervention Type
Biological
Intervention Name(s)
High-dosage of COVID-19 vaccine (Vero cell), Inactivated
Other Intervention Name(s)
High-dose CoronaVac®
Intervention Description
High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
Intervention Type
Biological
Intervention Name(s)
Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated
Other Intervention Name(s)
Medium-dose CoronaVac®
Intervention Description
Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
Primary Outcome Measure Information:
Title
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
Description
GMT of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)
Description
Seropositivity rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination
Other Pre-specified Outcome Measures:
Title
Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)
Description
GMI of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination
Title
Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
Description
The seroconversion rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination
Title
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
Description
GMT of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination
Time Frame
7 days after the booster dose vaccination
Title
Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)
Description
Seropositivity rate of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination
Time Frame
7 days after the booster dose vaccination
Title
Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)
Description
GMI of neutralizing antibodies(CZ02 strain)7 days after the booster dose vaccination
Time Frame
7 days after the booster dose vaccination
Title
Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
Description
The seroconversion rate of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination
Time Frame
7 days after the booster dose vaccination
Title
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
Description
GMT of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination
Time Frame
28 days after the booster dose vaccination
Title
Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)
Description
Seropositivity rate of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination
Time Frame
28 days after the booster dose vaccination
Title
Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)
Description
GMI of neutralizing antibodies(CZ02 strain)28 days after the booster dose vaccination
Time Frame
28 days after the booster dose vaccination
Title
Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
Description
The seroconversion rate of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination
Time Frame
28 days after the booster dose vaccination
Title
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
Description
GMT of neutralizing antibodies(CZ02 strain) 3 months after the booster dose vaccination
Time Frame
3 months after the booster dose vaccination
Title
Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
Description
The seroconversion rate of neutralizing antibodies(CZ02 strain)3 months after the booster dose vaccination
Time Frame
3 months after the booster dose vaccination
Title
Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
Description
GMT of neutralizing antibodies(CZ02 strain) 6 months after the booster dose vaccination
Time Frame
6 months after the booster dose vaccination
Title
Immunogenicity index-GMT of neutralizing antibodies(Delta strain)
Description
GMT of neutralizing antibodies(Delta strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination
Title
Immunogenicity index-Seropositivity rate of neutralizing antibodies(Delta strain)
Description
Seropositivity rate of neutralizing antibodies (Delta strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination
Title
Immunogenicity index-GMI of neutralizing antibodies(Delta strain)
Description
GMI of neutralizing antibodies(Delta strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination
Title
Immunogenicity index-seroconversion rate of neutralizing antibodies(Delta strain)
Description
The seroconversion rate of neutralizing antibodies (Delta strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination
Title
Immunogenicity index-GMT of neutralizing antibodies(Omicron Strain)
Description
GMT of neutralizing antibodies(Omicron Strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination
Title
Immunogenicity index-Seropositivity rate of neutralizing antibodies(Omicron Strain)
Description
Seropositivity rate of neutralizing antibodies (Omicron Strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination
Title
Immunogenicity index-GMI of neutralizing antibodies(Omicron Strain)
Description
GMI of neutralizing antibodies(Omicron Strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination
Title
Immunogenicity index-seroconversion rate of neutralizing antibodies(Omicron Strain)
Description
The seroconversion rate of neutralizing antibodies (Omicron Strain) 14 days after the booster dose vaccination
Time Frame
14 days after the booster dose vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy participants aged 18 years and above; Proven legal identity; The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan; Have received two doses of inactivated COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research & Development Co., Ltd and that is currently 5-9 months after the second dose. Exclusion Criteria: History of SARS-CoV-2 infection(laboratory confirmed); Have received three and more doses of inactivated COVID-19 vaccine; Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema; Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant; Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc; Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness; Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months; History of alcohol or drug abuse; Receipt of blood products within in the past 3 months; Receipt of other investigational drugs in the past 30 days; Receipt of attenuated live vaccines in the past 14 days; Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination; Axillary temperature >37.0°C; Participated in other clinical trials prior to enrollment and during the followup period, or planned to participate in other clinical trials during the clinical trial period; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingmei Feng, Master
Organizational Affiliation
Beijing YouAn Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Youan Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China

12. IPD Sharing Statement

Learn more about this trial

Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19

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