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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 : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Research and Development 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 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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 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 Other: Two doses of placebo 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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : May 22, 2020
Actual Primary Completion Date : August 28, 2020
Estimated Study Completion Date : July 30, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Vaccine-low dosage
low dosage inactivated SARS-CoV-2 vaccine
 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/0.5ml
Experimental: Experimental Vaccine-medium dosage
medium dosage inactivated SARS-CoV-2 vaccine
 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/0.5ml
Experimental: Experimental Vaccine-high dosage
high dosage inactivated SARS-CoV-2 vaccine
 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/0.5ml
Placebo Comparator: Placebo
No active ingredient in the placebo
 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.


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: 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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;
  • 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
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 Research and Development 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 Research and Development Co., Ltd.
ClinicalTrials.gov Identifier: NCT04383574    
Other Study ID Numbers: PRO-nCOV-1002
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: July 27, 2021
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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Vaccines
Immunologic Factors
Physiological Effects of Drugs