Clinical trial NCT04894227: Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 1080
Sex: ALL
Minimum age (years): 26
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 in susceptible population
timeFrame: Day 28 after the second dose
Secondary outcomes:
measure: Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in total population
timeFrame: Day 28 after the second dose
measure: Seropositivity rate of the neutralizing antibody to live SARS-CoV-2 in total population
timeFrame: Day 28 after the second dose
measure: GMT of the neutralizing antibody to live SARS-CoV-2 in total population
timeFrame: Day 28 after the second dose
measure: Geometric mean increase (GMI) of the neutralizing antibody to live SARS-CoV-2 in total population
timeFrame: Day 28 after the second dose
measure: Seroconversion rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population
timeFrame: Day 28 after the second dose
measure: Seropositive rate of the neutralizing antibody to live SARS-CoV-2 in susceptible population
timeFrame: Day 28 after the second dose
measure: GMI of the neutralizing antibody to live SARS-CoV-2 in susceptible population
timeFrame: Day 28 after the second dose
measure: Seropositivity rate of anti-SARS-CoV-2 S antibody
timeFrame: Day 28 after the second dose
measure: Seroconversion rate of anti-SARS-CoV-2 S antibody
timeFrame: Day 28 after the second dose
measure: Geometric mean concentration (GMC) of anti-SARS-CoV-2 S antibody
timeFrame: Day 28 after the second dose
measure: GMI of anti-SARS-CoV-2 S antibody
timeFrame: Day 28 after the second dose
measure: Incidence of adverse reactions after vaccination
timeFrame: From the beginning of the vaccination to 28 days after the second dose
Other outcomes:
Locations:
city: Huai'an
country: China
facility: Jingliang Wu
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial Center for Disease Prevention and Control
name: Hongxing Pan, Master
role: PRINCIPAL_INVESTIGATOR
References: