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Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection(COVID-19)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04383574
Recruitment Status : Active, not recruiting
First Posted : May 12, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE May 9, 2020
First Posted Date  ICMJE May 12, 2020
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE May 22, 2020
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2020)
  • Safety index-incidence of adverse reactions [ Time Frame: Day 0-28 after each dose vaccination ]
    Incidence of adverse reactions after each dose vaccination
  • Immunogenicity index-seroconversion rates of neutralizing antibody [ Time Frame: The 30th day after the second dose vaccination ]
    Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2020)
  • Safety index-incidence of serious adverse events [ Time Frame: From the beginning of the vaccination to 12 months after the second dose vaccination ]
    SAE will be collected throughout the clinical trial
  • Immunogenicity index-seropositive rates of neutralizing antibody [ Time Frame: The 30th day and the 12 month after the second dose vaccination ]
    Neutralizing antibody assay will be performed using the micro-neutralization method, and subjects with a antibody titer ≥1:8 will defined as seropositive.
  • Immunogenicity index-geometric mean titer (GMT) of neutralizing antibody [ Time Frame: The 30th day and the 12 month after the second dose vaccination ]
    Neutralizing antibody assay will be performed using the micro-neutralization method
  • Immunogenicity index-geometric mean ratio (GMR) of neutralizing antibody [ Time Frame: The 30th day after the second dose vaccination ]
    Neutralizing antibody assay will be performed using the micro-neutralization method. Ratio of post-vaccination titer divided by baseline titer will be calculated.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Immunogenicity Study of Inactivated Vaccine for Prevention of SARS-CoV-2 Infection(COVID-19)
Official Title  ICMJE A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine (Vero Cell) in Healthy Population Aged ≥60 Years
Brief Summary This study is a randomized, double-blinded, and placebo controlled phase 1&2 clinical trial of the SARS-CoV-2 inactivated vaccine manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of the experimental vaccine in healthy adults aged≥60 years.
Detailed Description This study is a randomized, double-blinded, single-center, placebo-controlled phase 1&2 clinical trial in adults aged≥60 years. The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 422 subjects will be enrolled, with 72 at phase 1, and 350 at phase 2. Subjects will be assigned to receive two doses of different dosage of experimental vaccine or placebo on the schedule of day 0,28.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
    The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 300SU/ml
  • Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
    The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 600SU/ml
  • Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
    The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 1200SU/ml
  • Other: Two doses of placebo at the schedule of day 0,28
    The placebo contains no active ingredient and manufactured by Sinovac Research & Development Co., Ltd.
Study Arms  ICMJE
  • Experimental: Experimental Vaccine-low dosage
    low dosage inactivated SARS-CoV-2 vaccine
    Intervention: Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
  • Experimental: Experimental Vaccine-medium dosage
    medium dosage inactivated SARS-CoV-2 vaccine
    Intervention: Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
  • Experimental: Experimental Vaccine-high dosage
    high dosage inactivated SARS-CoV-2 vaccine
    Intervention: Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
  • Placebo Comparator: Placebo
    No active ingredient in the placebo
    Intervention: Other: Two doses of placebo at the schedule of day 0,28
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2020)
422
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2021
Estimated Primary Completion Date August 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults aged ≥60 years;
  • Proven legal identity;
  • Participants should be capable of understanding the informed consent form, and such form should be signed prior to enrolment ;

Exclusion Criteria:

  • Travel history / residence history of Wuhan city and surrounding areas, or other communities with case reports within 14 days;
  • History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days;
  • Have contacted patients with fever or respiratory symptoms from Wuhan and surrounding areas, or from communities with case reports within 14 days;
  • Two or more cases of fever and / or respiratory symptoms in a small contact area of volunteers, such as home, office etc. within 14 days;
  • History of SARS-CoV-2 infection;
  • History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
  • Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;
  • 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;
  • Thyroid disease or history of thyroidectomy, spleenlessness, functional spleenlessness, spleenlessness or splenectomy resulting from any condition;
  • 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;
  • Receipt of inactivated or subunit vaccines in the past 7 days;
  • Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
  • Axillary temperature >37.0°C;
  • According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04383574
Other Study ID Numbers  ICMJE PRO-nCOV-1002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sinovac Biotech Co., Ltd ( Sinovac Research and Development Co., Ltd. )
Study Sponsor  ICMJE Sinovac Research and Development Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yuliang Zhao, Master Hubei Provincial Center for Disease Control and Prevention
PRS Account Sinovac Biotech Co., Ltd
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP