Clinical trial NCT05165966: Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19
Official title: A Randomized, Double-Blinded Clinical Trial to Evaluate the Immunogenicity Using Additional Dose of Medium-dosage or High-dosage COVID-19 Vaccine (Vero Cell), Inactivated in Populations Who Have Completed Primary Immunization 5-9 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COVID-19
Lead sponsor: Sinovac Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-12-21
Enrollment: 340
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 COVID-19 vaccine (Vero cell), Inactivated manufactured by Sinovac Life Sciences Co. , Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months

Detailed description: This study a randomized, double-blinded, phase Ⅳ clinical trial of COVID-19 vaccine (Vero cell), Inactivated.The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination using high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated in populations who have completed primary immunization 5-9 months.A total of 340 subjects who have completed primary immunization using two-dose Coronavac® 5-9 months were be enrolled.All of subjects were be randomly divided into two groups in a 1:1 ratio to receive high-dosage or medium-dosage of COVID-19 vaccine (Vero cell), Inactivated.

Eligibility criteria: Inclusion Criteria:

* Healthy participants aged 18 years and above;
* 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 COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd and that is currently 5-9 months after the second dose.

Exclusion Criteria:

* History of SARS-CoV-2 infection(laboratory confirmed);
* Have received three and more doses of inactivated COVID-19 vaccine;
* Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
* 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;
* Participated in other clinical trials prior to enrollment and during the followup 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: 14 days after the booster dose vaccination
Secondary outcomes:
measure: Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)
timeFrame: 14 days after the booster dose vaccination
Other outcomes:
measure: Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)
timeFrame: 14 days after the booster dose vaccination
measure: Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
timeFrame: 14 days after the booster dose vaccination
measure: Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
timeFrame: 7 days after the booster dose vaccination
measure: Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)
timeFrame: 7 days after the booster dose vaccination
measure: Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)
timeFrame: 7 days after the booster dose vaccination
measure: Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
timeFrame: 7 days after the booster dose vaccination
measure: Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
timeFrame: 28 days after the booster dose vaccination
measure: Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)
timeFrame: 28 days after the booster dose vaccination
measure: Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)
timeFrame: 28 days after the booster dose vaccination
measure: Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
timeFrame: 28 days after the booster dose vaccination
measure: Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
timeFrame: 3 months after the booster dose vaccination
measure: Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)
timeFrame: 3 months after the booster dose vaccination
measure: Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)
timeFrame: 6 months after the booster dose vaccination
measure: Immunogenicity index-GMT of neutralizing antibodies(Delta strain)
timeFrame: 14 days after the booster dose vaccination
measure: Immunogenicity index-Seropositivity rate of neutralizing antibodies(Delta strain)
timeFrame: 14 days after the booster dose vaccination
measure: Immunogenicity index-GMI of neutralizing antibodies(Delta strain)
timeFrame: 14 days after the booster dose vaccination
measure: Immunogenicity index-seroconversion rate of neutralizing antibodies(Delta strain)
timeFrame: 14 days after the booster dose vaccination
measure: Immunogenicity index-GMT of neutralizing antibodies(Omicron Strain)
timeFrame: 14 days after the booster dose vaccination
measure: Immunogenicity index-Seropositivity rate of neutralizing antibodies(Omicron Strain)
timeFrame: 14 days after the booster dose vaccination
measure: Immunogenicity index-GMI of neutralizing antibodies(Omicron Strain)
timeFrame: 14 days after the booster dose vaccination
measure: Immunogenicity index-seroconversion rate of neutralizing antibodies(Omicron Strain)
timeFrame: 14 days after the booster dose vaccination
Locations:
city: Beijing
country: China
facility: Beijing Youan Hospital Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing YouAn Hospital
name: Yingmei Feng, Master
role: PRINCIPAL_INVESTIGATOR
References: