Clinical trial NCT04962308: Clinical Trial of Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Healthy Adults
Official title: An Open-label,Phase Ⅳ Clinical Trial to Evaluate the Immunogenicity and Safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-07-14
Enrollment: 1400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is an open-label 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 immunogenicity and safety of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Healthy Population Aged From 18 to 59 Years.

Detailed description: This study is an open-label phase Ⅳ clinical trial in healthy adult aged 18-59 years. The experimental vaccine was manufactured by Sinovac Research and Development Co.,Ltd.. A total of 1400 subjects will be enrolled,the safety and immunogenicity of booster immunization were evaluated in 400 subjects (group A) who received two doses of primary immunization at an interval of 21 to 31 days. And the safety of booster immunization was evaluated in the extended safety group (group B), which included 1000 subjects.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 18-59;
* Have been received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd at an interval of 21 to 31 days for group A.Have been vaccination two doses of inactivated SARS-CoV-2 vaccine(CoronaVac)manufactured by Sinovac Research \& Development Co., Ltd for group B;
* The subjects can understand and voluntarily sign the informed consent form;
* Proven legal identity.

Exclusion Criteria:

* History of SARS-CoV-2 infection;
* Any serious adverse reactions that are causally related to vaccination during the primary immunization of the previous inactivated SARS-CoV-2 vaccine;
* Severe allergic reactions after primary immunization (including urticaria/rash within 30 minutes after vaccination);
* 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;
* Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before primary immunization and before booster immunization;
* Already pregnant or are breastfeeding, planning to get pregnant (according to subjects' self-report and urine pregnancy test results)
* Receipt of attenuated live vaccines within 14 days prior to booster vaccination;
* Receipt of inactivated or subunit vaccines within 7 days prior to booster vaccination;
* Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
* Axillary temperature \>37.0°C prior to booster vaccination;
* 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
timeFrame: 1 month after booster immunization
measure: Safety index-incidence of adverse reactions
timeFrame: 1 month after booster immunization
Secondary outcomes:
measure: Safety index-incidence of serious adverse events
timeFrame: 1 month after booster immunization
measure: Seroconversion rate,seropositivity rate and GMI of the neutralizing antibody to SARS-CoV-2
timeFrame: 1 month after booster immunization
measure: Seropositivity rate of IgG antibody
timeFrame: 1 month after booster immunization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Centers for Diseases Control and Prevention
Study officials:
affiliation: Beijing Center for Disease Control and Prevention
name: Jiang Wu, Master
role: PRINCIPAL_INVESTIGATOR
References: