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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04962308
Recruitment Status : Recruiting
First Posted : July 14, 2021
Last Update Posted : September 24, 2021
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: SARS-CoV-2 Inactivated Vaccine Biological: The SARS-CoV-2 Inactivated Vaccine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.
Actual Study Start Date : June 19, 2021
Actual Primary Completion Date : August 19, 2021
Estimated Study Completion Date : December 19, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Group
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.
Biological: SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Other Name: CoronaVac

Experimental: Control Group
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.
Biological: The SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Other Name: CoronaVac

Experimental: Safety group
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
Biological: SARS-CoV-2 Inactivated Vaccine
600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
Other Name: CoronaVac




Primary Outcome Measures :
  1. Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 [ Time Frame: 1 month after booster immunization ]
    GMT of the neutralizing antibody to live SARS-CoV-2 within 1month after booster immunization of the Inactivated SARS-CoV-2 vaccine.

  2. Safety index-incidence of adverse reactions [ Time Frame: 1 month after booster immunization ]
    Incidence rate of adverse reactions within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine


Secondary Outcome Measures :
  1. Safety index-incidence of serious adverse events [ Time Frame: 1 month after booster immunization ]
    Incidence rate of serious adverse events within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine

  2. Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2 [ Time Frame: 1 month after booster immunization ]
    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

  3. Seropositivity rate of IgG antibody [ Time Frame: 1 month after booster immunization ]
    Seropositivity rate of IgG antibody within 1 month after booster immunization of the Inactivated SARS-CoV-2 vaccine



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04962308


Contacts
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Contact: Jiang Wu, Master 13381081732 wj81732@hotmail.com

Locations
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China
Beijing Centers for Diseases Control and Prevention Recruiting
Beijing, China, 100013
Contact: Jiang Wu, Master    64407095    wj81732@hotmail.com   
Principal Investigator: Jiang Wu         
Sponsors and Collaborators
Sinovac Research and Development Co., Ltd.
Investigators
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Principal Investigator: Jiang Wu, Master Beijing Center for Disease Control and Prevention
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Responsible Party: Sinovac Research and Development Co., Ltd.
ClinicalTrials.gov Identifier: NCT04962308    
Other Study ID Numbers: PRO-nCOV-4003
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Vaccines
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs