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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell）


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 1<br>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）<br>* 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection<br>* Other names: CoronaVac;|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 2<br>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）<br>* 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection<br>* Other names: CoronaVac;|
| Experimental: Inactivated SARS-CoV-2 vaccine Lot 3<br>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）<br>* 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection<br>* Other names: CoronaVac;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 in susceptible population | GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population | Day 28 after the second dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in total population | Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population | Day 28 after the second dose | 
| Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 in total population | Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population | Day 28 after the second dose | 
| GMT of the neutralizing antibody to live SARS-CoV-2 in total population | GMT of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population | Day 28 after the second dose | 
| Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 in total population | GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in total population | Day 28 after the second dose | 
| Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population | Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population | Day 28 after the second dose | 
| Seropositive rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population | Seropositive rate of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population | Day 28 after the second dose | 
| GMI of the neutralizing antibody to live SARS-CoV-2 in susceptible population | GMI of the neutralizing antibody to live SARS-CoV-2 at day 28 after the second dose in susceptible population | Day 28 after the second dose | 
| Seropositivity rate of anti-SARS-CoV-2 S antibody | Seropositivity rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose | Day 28 after the second dose | 
| Seroconversion rate of anti-SARS-CoV-2 S antibody | Seroconversion rate of the anti-SARS-CoV-2 S antibody at day 28 after the second dose | Day 28 after the second dose | 
| Geometric mean concentration (GMC) of anti-SARS-CoV-2 S antibody | GMC of the anti-SARS-CoV-2 S antibody at day 28 after the second dose | Day 28 after the second dose | 
| GMI of anti-SARS-CoV-2 S antibody | GMI of the anti-SARS-CoV-2 S antibody at day 28 after the second dose | Day 28 after the second dose | 
| Incidence of adverse reactions after vaccination | Incidence of adverse reactions from the beginning of the vaccination to 28 days after the second dose | From the beginning of the vaccination to 28 days after the second dose |