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Immunogenicity and Safety of an Inactivated COVID-19 Vaccine

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ClinicalTrials.gov Identifier: NCT04953325
Recruitment Status : Recruiting
First Posted : July 7, 2021
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, placebo-controlled and open design, phase 4 clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd. The purpose of this study is to evaluate the immunogenicity and safety of the CoronaVac in healthy population aged 18 years and older.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Inactivated COVID-19 Vaccine Biological: 23-valent pneumococcal polysaccharide vaccine Biological: Inactivated Hepatitis A Vaccine Phase 4

Detailed Description:
This study is a randomized, placebo-controlled and opened, phase 4 clinical trial to evaluate the safety and immunogenicity of an inactivated COVID-19 vaccine(CoronaVac）in healthy population aged 18 years and older . The experimental vaccine is manufactured by Sinovac Research and Development Co.,Ltd. A total of 270 healthy subjects will be enrolled, including 135 adults aged 18-59 years and 135 elderly elderly aged 60 years and older. Subjects in each age group will be divided into two groups in a ratio of 1:1. Subjects in the experimental group will receive two doses of CoronaVac on day 0 and day 28. Subjects in the control group will receive one dose of 23-valent Pneumococcal Polysaccharide Vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of an Inactivated COVID-19 Vaccine for Prevention of COVID-19 in Healthy Population Aged 18 Years and Older
Actual Study Start Date : July 9, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : January 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Group
180 subjects (including 90 adults aged 18-59 years and 90 elderly aged 60 year and older）will receive two doses of inactivated COVID-19 vaccine on day 0 and day 28
 Biological: Inactivated COVID-19 Vaccine
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Other Name: CoronaVac
Placebo Comparator: Control Group
90 subjects (including 45 adults aged 18-59 years and 45 elderly aged 60 year and older）will receive one dose of 23-valent pneumococcal polysaccharide vaccine on day 0 and one dose of Inactivated Hepatitis A Vaccine on day 28
 Biological: 23-valent pneumococcal polysaccharide vaccine
25μg each of the following serotypes/each dose (0.5ml): 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F

Biological: Inactivated Hepatitis A Vaccine
500SU inactivated Hepatitis A virus in 1 mL of aluminium hydroxide solution per injection.


Outcome Measures
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Primary Outcome Measures :
  1. Seroconversion rate of the neutralizing antibody to SARS-CoV-2 [ Time Frame: Day 28 after the second dose ]
    Seroconversion rate of the neutralizing antibody to SARS-CoV-2 at day 28 after the second dose of inactivated COVID-19 vaccine


Secondary Outcome Measures :
  1. Seroconversion rate of the neutralizing antibody to SARS-CoV-2 [ Time Frame: Day 4, 14, 32,42 and 56 after the first dose ]
    Seroconversion rate of the neutralizing antibody to SARS-CoV-2 at different points after vaccination

  2. Seropositivity rate of the neutralizing antibody to SARS-CoV-2 [ Time Frame: Day 4, 14, 28, 32,42 and 56 after the first dose ]
    Seropositivity rate of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination

  3. GMT of the neutralizing antibody to SARS-CoV-2 [ Time Frame: Day 4, 14, 28, 32,42 and 56 after the first dose ]
    GMT of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination

  4. GMI of the neutralizing antibody to SARS-CoV-2 [ Time Frame: Day 4, 14, 28, 32,42 and 56 after the first dose ]
    GMT of of the neutralizing antibody to SARS-CoV-2 at different points after vaccination

  5. Geometric mean concentrations of anti-pneumococcal antibody for 23 serotypes (ELISA) [ Time Frame: Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine ]
    Geometric mean concentrations of anti-pneumococcal antibody for 23 serotypes (ELISA) at day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine

  6. Seroconversion rate of anti-pneumococcal antibody for 23 serotypes (ELISA) [ Time Frame: Day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine ]
    Seroconversion rate of anti-pneumococcal antibody for 23 serotypes (ELISA) at day 28 after vaccination of 23-valent pneumococcal polysaccharide vaccine

  7. Seroconversion rate of the hepatitis A antibody by Electrochemiluminescence [ Time Frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine ]
    Seroconversion rate of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine

  8. Seropositivity rate of the hepatitis A antibody by Electrochemiluminescence [ Time Frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine ]
    Seropositivity rate of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine

  9. GMT of the hepatitis A antibody by Electrochemiluminescence [ Time Frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine ]
    GMT of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine

  10. GMI of the hepatitis A antibody by Electrochemiluminescence [ Time Frame: Day 28 after vaccination of Inactivated Hepatitis A Vaccine ]
    GMI of the hepatitis A antibody at day 28 after vaccination of Inactivated Hepatitis A Vaccine

  11. Occurrence of abnormal changes of laboratory safety examinations [ Time Frame: Day 4, 14, 28, 32,42 and 56 after the first dose ]
    Occurrence of abnormal changes of laboratory safety examinations (Platelet factor 4 HIT, blood sugar, ESR, White blood cell count, hemoglobin, platelet count and Coagulation function index)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy population aged 18 years and above;
  • The subjects can understand and voluntarily sign the informed consent form;
  • Proven legal identity.

Exclusion Criteria:

  • History of SARS-CoV-2 infection;
  • Have received any COVID-19 vaccine;
  • Participants with abnormal fasting blood glucose or diabetes;
  • 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;
  • 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;
  • Diseases or factors that are prone to thrombosis or bleeding, such as thrombophlebitis, major surgery/trauma, hereditary thrombotic disorder, sepsis, inflammatory bowel disease, severe varicose veins, May-Thurner syndrome, fibrinolytic activity enhancement disease, history of cardiac stent surgery, allergic purpura, etc.;
  • Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
  • Abnormal hematological laboratory test results outside the reference range during previous physical examination within one year: Blood routine indicators (white blood cell count, hemoglobin, platelet count), Coagulation function test (prothrombin time PT, activated partial prothrombin time APTT, fibrinogen FIB, thrombin time TT, international standardized ratio INR, D-dimer), other indicators (blood glucose, platelet factor 4 HIT ELISA, erythrocyte sedimentation rate);
  • 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;
  • Axillary temperature >37.0°C;
  • Already pregnant (including a positive urine pregnancy test) or are breastfeeding, planning to get pregnant within 3 months;
  • History of taking aspirin drugs and other drugs that affect blood coagulation;
  • 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): NCT04953325


Contacts
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Contact: Li Zhang, Master 86-0531-82679703 zl9127@163.com

Locations
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China, Shandong
Rushan City Center for Disease Control and Prevention Recruiting
Weihai, Shandong, China, 250014
Contact: Qingfan Cao, Master    86-0631-6683301    jhmyrushan@163.com   
Sponsors and Collaborators
Sinovac Research and Development Co., Ltd.
Investigators
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Principal Investigator: Li Zhang, Master Shandong Provincial Center for Disease Control and Prevention
More Information
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Responsible Party: Sinovac Research and Development Co., Ltd.
ClinicalTrials.gov Identifier: NCT04953325    
Other Study ID Numbers: PRO-nCOV-MA4004-SD
First Posted: July 7, 2021    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
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs