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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 : Completed
First Posted : May 12, 2020
Last Update Posted : August 11, 2022
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Life Sciences Co., Ltd. )

Study Description
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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 Life Sciences 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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Biological: Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Biological: Two doses of placebo at the schedule of day 0,28 Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 Phase 1 Phase 2

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 Life Sciences Co. , Ltd. A total of 422 subjects will be enrolled, with 72 in phase 1 and 350 in phase 2. 72 Subjects with 36 in medium-dosage group and 36 in high-dosage group 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 group 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(the third dose ) 6 months after primary immunization.And subjects in medium-dosage group and high -dosage group will receive the second booster dose (the fourth dose) 1 year after the second dose.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : May 22, 2020
Actual Primary Completion Date : December 28, 2021
Actual Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Vaccine-medium dosage
24 participants in medium-dosage group 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 in medium-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose ) and the second booster dose (the fourth dose) 1 year after the second dose.
 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(the third dose) 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.And the second booster dose (the fourth dose) 1 year after the second dose.
Experimental: Experimental Vaccine-high dosage
24 participants in high-dosage group 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 in high-dosage group in phase Ⅱ will receive two doses of primary immunization according to the immunization schedule of day 0,28 ,1 dose of booster immunization 6 months after primary immunization(the third dose) and the second booster dose (fourth dose) 1 year after the second dose .
 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(the third dose) 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.And the second booster dose (the fourth dose) 1 year after the second dose.
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.
 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.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Safety index-incidence of adverse reactions [ Time Frame: Day 0-28 after each dose vaccination ]
    Incidence of adverse reactions after each dose vaccination

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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;

  5. 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


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. Immunogenicity index-seropositive rate,GMT and GMI of neutralizing antibodies [ Time Frame: 14 days after the fourth dose ]
    The seropositive rate, GMT and GMI of neutralizing antibody against CZ, Delta and Omicron antigens 14 days after the fourth dose.

  8. Immunogenicity index-Seropositive rate and GMTof neutralizing antibodies [ Time Frame: 6 months after the fourth dose ]
    The seropositive rate and GMT of neutralizing antibody against Delta and Omicron antigens 6 months after the fourth dose.


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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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): NCT04383574


Locations
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China, Hebei
Renqiu City Center for Disease Control and Prevention
Renqiu, Hebei, China, 062550
Sponsors and Collaborators
Sinovac Life Sciences Co., Ltd.
Investigators
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Principal Investigator: Yuliang Zhao, Master Hubei Provincial Center for Disease Control and Prevention
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sinovac Life Sciences Co., Ltd.
ClinicalTrials.gov Identifier: NCT04383574    
Other Study ID Numbers: PRO-nCOV-1002
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: August 11, 2022
Last Verified: July 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
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs