Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19

Phase 4

• Conditions: COVID-19

• Registration Number: NCT05079217
• Lead Sponsor: Sinovac Biotech Co., Ltd

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 .

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-15
• Study Start: 2021-12-17
• Primary Completion: 2021-12-21
• Last Update Submitted: 2022-02-13
• Last Update Posted: 2022-03-02
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain）	Day 28 after booster vaccination	GMT of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination.

Secondary Outcome Measures

Name	Time	Method
Immunogenicity index-seropositive rate of neutralizing antibodies（CZ02 strain）	Day 28 after booster vaccination	The seropositive rate of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies（CZ02 strain）	Day 28 after booster vaccination	The seroconversion rate of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies（CZ02 strain）	Day 28 after booster vaccination	GMI of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies（Delta Strain）	Day 28 after booster vaccination	The seropositive rate of neutralizing antibodies（Delta Strain） 28 days after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies（Delta Strain）	Day 28 after booster vaccination	The seroconversion rate of neutralizing antibodies（Delta Strain） 28 days after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies（Delta Strain）	Day 28 after booster vaccination	GMI of neutralizing antibodies（Delta Strain） 28 days after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies（Omicron Strain）	Day 28 after booster vaccination	The seroconversion rate of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies（Omicron Strain）	Day 28 after booster vaccination	The seropositive rate of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies（Omicron Strain）	Day 28 after booster vaccination	GMI of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
Immunogenicity index-GMT of neutralizing antibodies（Omicron Strain）	Day 28 after booster vaccination	GMT of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
Immunogenicity index-GMT of neutralizing antibodies（Delta Strain）	Day 28 after booster vaccination	GMT of neutralizing antibodies（Delta Strain） 28 days after booster vaccination

Trial Locations

Locations (1)

Xinqi City Center for Disease Control and Prevention; 🇨🇳 Xinqi, Jiangsu, China

Xinqi City Center for Disease Control and Prevention

🇨🇳Xinqi, Jiangsu, China