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Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults

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ClinicalTrials.gov Identifier: NCT04894227
Recruitment Status : Active, not recruiting
First Posted : May 20, 2021
Last Update Posted : August 18, 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 double-blind, randomized 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 lot-to-lot consistency, immunogenicity and safety of CoronaVac in healthy adults aged 26-45 years.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell） Phase 4

Detailed Description:
This study is a double-blind, randomized phase Ⅳ clinical trial in healthy adults aged 26-45 years to evaluate the lot-to-lot consistency, immunogenicity and safety of the commercial-scale CoronaVac in healthy adults aged 26-45 years .The experimental vaccine was manufactured by Sinovac Research & Development Co.,Ltd. A total of 1080 healthy subjects aged 26 to 45 years old will be enrolled.The subjects will be randomly divided into three groups in a ratio of 1:1:1 to received two doses of vaccine on day 0 and day 28.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Double-blind, Randomized Clinical Trial to Evaluate the Lot-to-lot Consistency, Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac） in Health Adults Aged 26-45 Years
Actual Study Start Date : May 11, 2021
Actual Primary Completion Date : May 11, 2021
Estimated Study Completion Date : November 30, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Inactivated SARS-CoV-2 vaccine Lot 1
Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 1 according to 0,28-day immunization schedule.
 Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Name: CoronaVac
Experimental: Inactivated SARS-CoV-2 vaccine Lot 2
Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 2 according to 0,28-day immunization schedule.
 Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Name: CoronaVac
Experimental: Inactivated SARS-CoV-2 vaccine Lot 3
Participants (n=360) aged 26-45 years will receive Inactivated SARS-CoV-2 vaccine Lot 3 according to 0,28-day immunization schedule.
 Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）
600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Other Name: CoronaVac


Outcome Measures
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Primary Outcome Measures :
  1. Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 in susceptible population [ Time Frame: Day 28 after the second dose ]
    GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population


Secondary Outcome Measures :
  1. Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in total population [ Time Frame: Day 28 after the second dose ]
    Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population

  2. Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 in total population [ Time Frame: Day 28 after the second dose ]
    Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population

  3. GMT of the neutralizing antibody to live SARS-CoV-2 in total population [ Time Frame: Day 28 after the second dose ]
    GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population

  4. Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 in total population [ Time Frame: Day 28 after the second dose ]
    GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population

  5. Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population [ Time Frame: Day 28 after the second dose ]
    Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population

  6. Seropositive rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population [ Time Frame: Day 28 after the second dose ]
    Seropositive rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population

  7. GMI of the neutralizing antibody to live SARS-CoV-2 in susceptible population [ Time Frame: Day 28 after the second dose ]
    GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population

  8. Seropositivity rate of anti-SARS-CoV-2 S antibody [ Time Frame: Day 28 after the second dose ]
    Seropositivity rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose

  9. Seroconversion rate of anti-SARS-CoV-2 S antibody [ Time Frame: Day 28 after the second dose ]
    Seroconversion rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose

  10. Geometric mean concentration (GMC) of anti-SARS-CoV-2 S antibody [ Time Frame: Day 28 after the second dose ]
    GMC of the anti-SARS-CoV-2 S antibody at day 28 after the second dose

  11. GMI of anti-SARS-CoV-2 S antibody [ Time Frame: Day 28 after the second dose ]
    GMI of the anti-SARS-CoV-2 S antibody at day 28 after the second dose

  12. Incidence of adverse reactions after vaccination [ Time Frame: From the beginning of the vaccination to 28 days after the second dose ]
    Incidence of adverse reactions from the beginning of the vaccination to 28 days after the second dose


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   26 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults aged 26-45;
  • The subjects can understand and voluntarily sign the informed consent form ;
  • Proven legal identity.

Exclusion Criteria:

  • Travel history / residence history of communities with case reports within 14 days prior to the study;
  • History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within 14 days prior to the study;
  • Have contacted patients with fever or respiratory symptoms from communities with case reports within 14 days prior to the study;
  • 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 prior to the study;
  • History of SARS-CoV-2 infection or receiving COVID-19 vaccine;
  • 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 (Systemic lupus erythematosus)or immunodeficiency / immunosuppression(HIV,history after organ transplantation)
  • 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;
  • Onset of various acute or chronic diseases within 7 days prior to the study;
  • Axillary temperature >37.0°C;
  • Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 2 months;
  • The subjects participated in other clinical trials during the follow-up period, or will be planned within 3 months;
  • 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): NCT04894227


Locations
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China, Jiangsu
Jingliang Wu
Huai'an, Jiangsu, China, 223300
Sponsors and Collaborators
Sinovac Research and Development Co., Ltd.
Investigators
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Principal Investigator: Hongxing Pan, Master Jiangsu Provincial Center for Disease Prevention and Control
More Information
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Responsible Party: Sinovac Research and Development Co., Ltd.
ClinicalTrials.gov Identifier: NCT04894227    
Other Study ID Numbers: PRO-nCOV-4001
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No