Safety and Immunogenicity Study of Booster Vaccination With COVID-19 Vaccine (Vero Cell),Inactivated From Different Manufactures for Prevention of COVID-19
- Conditions
- COVID-19
- Interventions
- Biological: Experimental vaccine 2Biological: Experimental vaccine 1Biological: Experimental vaccine 3
- Registration Number
- NCT05165732
- Lead Sponsor
- Sinovac Research and Development Co., Ltd.
- Brief Summary
This is a randomized, Open, control phase Ⅳ clinical trial of inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co., Ltd,Beijing institute of Biological Products Co.,Ltd and Wuhan Institute of Biological Products Co.,Ltd.The purpose of this study is to explore booster Immunization of SARS-CoV-2 Inactivated Vaccine from different manufactures in adults aged 18-45 years old Previously Vaccinated with inactivated COVID-19 vaccine
- Detailed Description
This study a randomized, Open, control phase Ⅳclinical trial of inactivated COVID-19 vaccine .The purpose of this study is to explore booster Immunization of SARS-CoV-2 inactivated vaccine from different manufactures in adults aged 18-45 years old previously vaccinated with inactivated COVID-19 vaccine.A total of 480 subjects who have completed vaccination of two doses of inactivated COVID-19 vaccine for 6 to 8 months will be enrolled.In this study ,96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd.(experimental group 1).192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd. will be randomly divided into two groups (experimental group 2 and experimental group 3) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. and Beijing institute of Biological Products Co., Ltd,respectively.192 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.will be randomly divided into two groups(experimental group 4 and experimental group 5) in a 1:1 ratio and receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. and Wuhan Institute of Biological Products Co.,Ltd.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 480
- Adults aged 18-45;
- 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 completed two doses of SARS-CoV-2 inactivated vaccine vaccination for 6 to 8 months(the interval between the two doses vaccine of primary immunization is 21~35 days, and the two doses vaccine of primary immunization should be manufactured by the same manufactures).
-
History of SARS-CoV-2 infection(laboratory confirmed);
-
Have received inactivated SARS-CoV-2 vaccine from other manufacturers other than Sinovac Life Sciences Co., Ltd.,Beijing Institute of Biological Products Co.,Ltd.and Wuhan Institute of Biological Products Co.,Ltd.and 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 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 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Group 3 Experimental vaccine 2 96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co.,Ltd. Experimental Group 1 Experimental vaccine 1 96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. Experimental Group 2 Experimental vaccine 1 96 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Beijing institute of Biological Products Co,Ltd. will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. Experimental Group 4 Experimental vaccine 1 92 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Sinovac Research \& Development Co.,Ltd. Experimental Group 5 Experimental vaccine 3 92 subjects who completed primary immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd will receive one dose of booster immunization with inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.
- Primary Outcome Measures
Name Time Method Immunogenicity index-seroconversion rate (4-fold and above increase)of neutralizing antibodies 28 days after booster dose Seroconversion rate (4-fold and above increase)of neutralizing antibodies 28 days after booster dose.
Immunogenicity index-seropositive rate of neutralizing antibody 28 days after booster dose Seropositive rate of neutralizing antibody 28 days after booster dose.
Immunogenicity index-GMT of neutralizing antibodies 28 days after booster dose GMT of neutralizing antibody 28 days after booster dose.
- Secondary Outcome Measures
Name Time Method Safety index-Incidence of adverse reactions 0-7 days after booster dose Incidence of adverse reactions occurred 0-7 days after booster dose.
Safety index-Incidence of SAEs and AESIs 0-28 days after booster Incidence of SAEs and AESIs occured 0-28 days after booster.
Trial Locations
- Locations (1)
Yanhe Tujia Autonomous County Center for Disease Control and Prevention
🇨🇳Tongren, Guizhou, China