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Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
SARS-CoV-2 Inactivated Vaccine
The SARS-CoV-2 Inactivated Vaccine
Sponsored by
Sinovac Research and Development 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 - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults aged 18-59;
  • Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd at an interval of 21 to 31 days for group A.Have been vaccination two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd for group B;
  • The subjects can understand and voluntarily sign the informed consent form;
  • Proven legal identity.

Exclusion Criteria:

  • History of SARS-CoV-2 infection;
  • Any serious adverse reactions that are causally related to vaccination during the primary immunization of the previous inactivated SARS-CoV-2 vaccine;
  • Severe allergic reactions after primary immunization (including urticaria/rash within 30 minutes after vaccination);
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • 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;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before primary immunization and before booster immunization;
  • Already pregnant or are breastfeeding, planning to get pregnant (according to subjects' self-report and urine pregnancy test results)
  • Receipt of attenuated live vaccines within 14 days prior to booster vaccination;
  • Receipt of inactivated or subunit vaccines within 7 days prior to booster vaccination;
  • Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
  • Axillary temperature >37.0°C prior to booster vaccination;
  • 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 Centers for Diseases Control and PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Experimental Group

Control Group

Safety group

Arm Description

200 subjects in group A1 will receive one dose of booster immunization 3 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine.

200 subjects in group A2 will receive one dose of booster immunization 5 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine.

1000 subjects in group B will be enrolled and receive 1 dose of booster immunization more than 3 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine

Outcomes

Primary Outcome Measures

Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
GMT of the neutralizing antibody to live SARS-CoV-2 within 1month after booster immunization of the Inactivated SARS-CoV-2 vaccine.
Safety index-incidence of adverse reactions
Incidence rate of adverse reactions within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine

Secondary Outcome Measures

Safety index-incidence of serious adverse events
Incidence rate of serious adverse events within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine
Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2
Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2 within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine
Seropositivity rate of IgG antibody
Seropositivity rate of IgG antibody within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine

Full Information

First Posted
July 13, 2021
Last Updated
September 22, 2021
Sponsor
Sinovac Research and Development Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04962308
Brief Title
Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults
Official Title
An Open-label,Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2021 (Actual)
Primary Completion Date
August 19, 2021 (Actual)
Study Completion Date
December 19, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Research and Development 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 study is an open-label phase Ⅳ clinical trial of the inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.
Detailed Description
This study is an open-label phase Ⅳ clinical trial in healthy adult aged 18-59 years. The experimental vaccine was manufactured by Sinovac Research and Development Co.,Ltd.. A total of 1400 subjects will be enrolled,the safety and immunogenicity of booster immunization were evaluated in 400 subjects (group A) who received two doses of primary immunization at an interval of 21 to 31 days. And the safety of booster immunization was evaluated in the extended safety group (group B), which included 1000 subjects.

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
None (Open Label)
Allocation
Randomized
Enrollment
1400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
200 subjects in group A1 will receive one dose of booster immunization 3 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
200 subjects in group A2 will receive one dose of booster immunization 5 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine.
Arm Title
Safety group
Arm Type
Experimental
Arm Description
1000 subjects in group B will be enrolled and receive 1 dose of booster immunization more than 3 months after the completion of the second dose of primary immunization of the SARS-CoV-2 Inactivated vaccine
Intervention Type
Biological
Intervention Name(s)
SARS-CoV-2 Inactivated Vaccine
Other Intervention Name(s)
CoronaVac
Intervention Description
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Intervention Type
Biological
Intervention Name(s)
The SARS-CoV-2 Inactivated Vaccine
Other Intervention Name(s)
CoronaVac
Intervention Description
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Primary Outcome Measure Information:
Title
Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2
Description
GMT of the neutralizing antibody to live SARS-CoV-2 within 1month after booster immunization of the Inactivated SARS-CoV-2 vaccine.
Time Frame
1 month after booster immunization
Title
Safety index-incidence of adverse reactions
Description
Incidence rate of adverse reactions within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine
Time Frame
1 month after booster immunization
Secondary Outcome Measure Information:
Title
Safety index-incidence of serious adverse events
Description
Incidence rate of serious adverse events within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine
Time Frame
1 month after booster immunization
Title
Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2
Description
Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2 within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine
Time Frame
1 month after booster immunization
Title
Seropositivity rate of IgG antibody
Description
Seropositivity rate of IgG antibody within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine
Time Frame
1 month after booster immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults aged 18-59; Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd at an interval of 21 to 31 days for group A.Have been vaccination two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research & Development Co., Ltd for group B; The subjects can understand and voluntarily sign the informed consent form; Proven legal identity. Exclusion Criteria: History of SARS-CoV-2 infection; Any serious adverse reactions that are causally related to vaccination during the primary immunization of the previous inactivated SARS-CoV-2 vaccine; Severe allergic reactions after primary immunization (including urticaria/rash within 30 minutes after vaccination); Autoimmune disease or immunodeficiency / immunosuppression; 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; Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before primary immunization and before booster immunization; Already pregnant or are breastfeeding, planning to get pregnant (according to subjects' self-report and urine pregnancy test results) Receipt of attenuated live vaccines within 14 days prior to booster vaccination; Receipt of inactivated or subunit vaccines within 7 days prior to booster vaccination; Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination; Axillary temperature >37.0°C prior to booster vaccination; According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Wu, Master
Phone
13381081732
Email
wj81732@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Wu, Master
Organizational Affiliation
Beijing Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Centers for Diseases Control and Prevention
City
Beijing
ZIP/Postal Code
100013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Wu, Master
Phone
64407095
Email
wj81732@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jiang Wu

12. IPD Sharing Statement

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Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults

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