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

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ClinicalTrials.gov Identifier: NCT04383574
Recruitment Status : Active, not recruiting
First Posted : May 12, 2020
Last Update Posted : August 3, 2021
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 3, 2021
Actual Study Start Date  ICMJE May 22, 2020
Actual Primary Completion Date August 28, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2021)
  • 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: 28 days after the second dose vaccination ]
    The seroconversion rate of neutralizing antibody 28 days after the second dose vaccination.
Original 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2021)
  • Safety index-incidence rate of adverse reactions [ Time Frame: within 7 days after each dose vaccination ]
    Incidence rate of adverse reactions within 7 days after each dose vaccination
  • Safety index-incidence rate of serious adverse events in phase Ⅰ [ Time Frame: From the beginning of the vaccination to 6 months after the booster immunization ]
    Incidence rate of SAEs from the beginning of the vaccination to 6 months after the booster immunization in phase Ⅰ
  • Safety index-incidence rate of serious adverse events in phase Ⅱ [ Time Frame: From the beginning of the vaccination to 12 months after the booster immunization vaccination ]
    Incidence rate of SAEs from the beginning of the vaccination to 12 months after the booster immunization vaccination in phase Ⅱ
  • Immunogenicity index-seropositive rate, GMT, and GMI of neutralizing antibodies [ Time Frame: 28 days after the second dose vaccination ]
    The seropositive rate, GMT, and GMI of neutralizing antibodies 28 days after the second dose vaccination;
  • Immunogenicity index-seroconversion rate, seropositive rate, GMT, and GMI in phase Ⅰ [ Time Frame: 28 days after the first dose vaccination in phase Ⅰ ]
    The seroconversion rate, seropositive rate, GMT, and GMI 28 days after the first dose vaccination in phase Ⅰ
Original 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.
Current Other Pre-specified Outcome Measures
 (submitted: July 27, 2021)
  • Immunogenicity index -seropositive rate and GMT of neutralizing antibodies [ Time Frame: 6 months after the second dose vaccination ]
    The seropositive rate and GMT 6 months after the second dose vaccination
  • Immunogenicity index -seropositive rate and GMT of neutralizing antibodies in phase Ⅰ [ Time Frame: 12 months after the second dose vaccination ]
    The seropositive rate and GMT 12 months after the second dose vaccination in phase Ⅰ
  • Immunogenicity index -seropositive rate, GMT, and GMI of neutralizing antibodies [ Time Frame: 28 days after the booster vaccination ]
    The seropositive rate, GMT, and GMI 28 days after the booster vaccination in phase Ⅰ
  • Immunogenicity index -seropositive rate, GMT of neutralizing antibodies in phase Ⅱ [ Time Frame: 7 days (or 14 days) and 28 days after the booster vaccination ]
    The seropositive rate, GMT, and GMI 7 days (or 14 days) and 28 days after the booster vaccination in phase Ⅱ
  • Immunogenicity index -seropositive rate and GMT of neutralizing antibodies [ Time Frame: 6 months after the booster vaccination ]
    The seropositive rate and GMT 6 months after the booster vaccination
  • Immunogenicity index -seropositive rate and GMT of neutralizing antibodies in phase Ⅱ [ Time Frame: 12 months after the booster vaccination ]
    The seropositive rate and GMT 12 months after the booster vaccination in phase Ⅱ
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-blind, Placebo-controlled Clinical Trial, to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cell), in Healthy Elderly Aged 60 Years and Above
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 elderly aged 60 years and above.
Detailed Description This study is a randomized, double-blinded, single-center, placebo-controlled phase 1&2 clinical trial in healthy elderly aged 60 years and above. The experimental vaccine and placebo were both manufactured by Sinovac Research & Development Co., Ltd. A total of 422 subjects will be enrolled, with 72 in phase 1 and 350 in phase 2. 72 Subjects with 36 at medium dosage stage and 36 at high dosage stage in phase 1 will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and the subjects at each dosage stage will be assigned in a 2:1 ratio to receive investigational vaccine or placebo respectively.All enrolled subjects will receive 1 dose of booster immunization 1 year after primary immunization.350 Subjects in phase 2 will receive two doses of primary immunization according to the immunization schedule of day 0,28,the subjects will be assigned in a ratio of 2:2:2:1 to receive the low dosage, medium dosage, high dosage vaccine, or placebo. All enrolled subjects will received 1 dose of booster immunization 6 months after primary immunization.
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 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..Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
  • 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..Two doses of high dosage (1200SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization with medium dosage (1200SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
  • Biological: Two doses of placebo at the schedule of day 0,28
    The placebo was manufactured by Sinovac Research & Development Co., Ltd., Two doses of placebo at the schedule of day 0,28,and one dose of booster immunization with placebo 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
  • 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..Two doses of low dosage (300SU/0.5ml)experimental vaccine at the schedule of day 0,28,and one dose of booster immunization with low dosage (300SU/0.5ml) experimental vaccine 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
Study Arms  ICMJE
  • Experimental: Experimental Vaccine-medium dosage
    24 participants at medium dosage stage in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants at medium dosage stage in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
    Intervention: Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
  • Experimental: Experimental Vaccine-high dosage
    24 participants at high dosage stage in phase Ⅰ will receive two doses of primary immunization according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 100 participants at high dosage stage in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
    Intervention: Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
  • Placebo Comparator: Placebo
    24 participants including 12 at medium dosage stage and 12 at high dosage in phase Ⅰ will receive two doses of placebo according to the immunization schedule of day 0, 28 and will receive 1 dose of booster immunization 1 year after primary immunization; 50 participants in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
    Intervention: Biological: Two doses of placebo at the schedule of day 0,28
  • Experimental: Experimental Vaccine-low dosage
    100 participants at low dosage stage in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 and will receive 1 dose of booster immunization 6 months after primary immunization.
    Intervention: Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
Publications * Wu Z, Hu Y, Xu M, Chen Z, Yang W, Jiang Z, Li M, Jin H, Cui G, Chen P, Wang L, Zhao G, Ding Y, Zhao Y, Yin W. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Jun;21(6):803-812. doi: 10.1016/S1473-3099(20)30987-7. Epub 2021 Feb 3.

*   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 July 30, 2021
Actual Primary Completion Date August 28, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults aged ≥60 years;
  • Be able to understand and sign the informed consent voluntarily;
  • Provide legal identification;

Exclusion Criteria:

  • Travel / residence history of Wuhan city and surrounding areas or other communities with case reports within 14 days prior to the enrolment;
  • Contact with SARS-CoV-2 infected persons (positive for nucleic acid detection) within 14 days prior to the enrolment;
  • Contact patients with fever or respiratory symptoms from Wuhan city and surrounding areas, or from communities with case reports within 14 days prior to the enrolment;
  • Two or more cases of fever and / or respiratory symptoms in a small contact area of subjects, such as family, office, school class or other places within 14 days prior to the enrolment;
  • History of SARS;
  • History of SARS-CoV-2 infection;
  • History of asthma, allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneuroedema;
  • Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
  • Autoimmune disease or immunodeficiency / immunosuppression;
  • Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
  • Serious nervous system disease (epilepsy, convulsion or convulsion) or psychosis;
  • Thyroid disease or history of thyroidectomy, asplenia, functional asplenia, asplenia 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 non-complicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • Long history of alcohol or drug abuse;
  • Receipt of blood products 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 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 July 2021

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