Clinical trial NCT05079217: Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19
Official title: A Randomized, Double-Blinded Clinical Trial to Evaluate Additional Dose of Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine in Healthy Individuals Previously Vaccinated With CoronaVac
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-10-15
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine manufactured by manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.

Detailed description: This study a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine .The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.A total of 1200 subjects who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month will be enrolled.All of subjects will be randomly divided into two groups in a 1:1 ratio .Subjects in experimental group will receive high-dosage SARS-CoV-2 inactivated vaccine.Subjects in control group will receive medium-dosage SARS-CoV-2 inactivated vaccine .

Eligibility criteria: Inclusion Criteria:

* Adults aged 18-59;
* Proven legal identity;
* The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
* Have received two doses of inactivated SARS-CoV-2 vaccine(CoronaVac) manufactured by Sinovac Research \& Development Co., Ltd at an interval of 21 to 35 days and is currently 6-8 months (180 to 240 days) after the second dose.

Exclusion Criteria:

* History of SARS-CoV-2 infection(laboratory confirmed);
* Have received three and more doses of inactivated SARS-CoV-2 vaccine;
* Severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization;
* Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
* 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;
* 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;
* Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
* Axillary temperature \>37.0°C;
* Already pregnant or are breastfeeding, planning to get pregnant within 1months (according to subjects' self-report and urine pregnancy test results);
* Participated in other clinical trials prior to enrollment and during the follow-up period, or planned to participate in other clinical trials during the clinical trial period;
* 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: Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain）
timeFrame: Day 28 after booster vaccination
Secondary outcomes:
measure: Immunogenicity index-seropositive rate of neutralizing antibodies（CZ02 strain）
timeFrame: Day 28 after booster vaccination
measure: Immunogenicity index-seroconversion rate of neutralizing antibodies（CZ02 strain）
timeFrame: Day 28 after booster vaccination
measure: Immunogenicity index-GMI of neutralizing antibodies（CZ02 strain）
timeFrame: Day 28 after booster vaccination
measure: Immunogenicity index-seropositive rate of neutralizing antibodies（Delta Strain）
timeFrame: Day 28 after booster vaccination
measure: Immunogenicity index-seroconversion rate of neutralizing antibodies（Delta Strain）
timeFrame: Day 28 after booster vaccination
measure: Immunogenicity index-GMI of neutralizing antibodies（Delta Strain）
timeFrame: Day 28 after booster vaccination
measure: Immunogenicity index-seroconversion rate of neutralizing antibodies（Omicron Strain）
timeFrame: Day 28 after booster vaccination
measure: Immunogenicity index-seropositive rate of neutralizing antibodies（Omicron Strain）
timeFrame: Day 28 after booster vaccination
measure: Immunogenicity index-GMI of neutralizing antibodies（Omicron Strain）
timeFrame: Day 28 after booster vaccination
measure: Immunogenicity index-GMT of neutralizing antibodies（Omicron Strain）
timeFrame: Day 28 after booster vaccination
measure: Immunogenicity index-GMT of neutralizing antibodies（Delta Strain）
timeFrame: Day 28 after booster vaccination
Other outcomes:
measure: Immunogenicity index-the seropositive rate of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain）
timeFrame: 6 months after the booster vaccination
measure: Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain）
timeFrame: 6 months after the booster vaccination
Locations:
city: Xinqi
country: China
facility: Xinqi City Center for Disease Control and Prevention
state: Jiangsu
Study officials:
affiliation: Jiangsu Provincial Center for Disease Prevention and Control
name: Hongxing Pan, Master
role: PRINCIPAL_INVESTIGATOR
References: