Safety and Immunogenicity Study of Booster Vaccination With COVID-19 Vaccine (Vero Cell),Inactivated From Different Manufactures for Prevention of COVID-19
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Experimental Group 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. |
Biological: Experimental vaccine 1
Inactivated COVID-19 vaccine manufactured by Sinovac Life Sciences Co., Ltd.600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
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Experimental: Experimental Group 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 Sinovac Research & Development Co.,Ltd. |
Biological: Experimental vaccine 1
Inactivated COVID-19 vaccine manufactured by Sinovac Life Sciences Co., Ltd.600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
|
Experimental: Experimental Group 3 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. |
Biological: Experimental vaccine 2
Inactivated COVID-19 vaccine manufactured by Beijing Institute of Biological Products Co.,Ltd.4ug inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
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Experimental: Experimental Group 4 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. |
Biological: Experimental vaccine 1
Inactivated COVID-19 vaccine manufactured by Sinovac Life Sciences Co., Ltd.600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
|
Experimental: Experimental Group 5 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. |
Biological: Experimental vaccine 3
Inactivated COVID-19 vaccine manufactured by Wuhan Institute of Biological Products Co.,Ltd.200WU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection.
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Outcome Measures
Primary Outcome Measures
- Immunogenicity index-GMT of neutralizing antibodies [28 days after booster dose]
GMT of neutralizing antibody 28 days after booster dose.
- 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.
Secondary Outcome Measures
- Safety index-Incidence of adverse reactions [0-28 days after booster]
Incidence of adverse reactions occured 0-28 days after booster
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults aged 18-45;
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Proven legal identity;
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The subjects can understand and voluntarily sign the informed consent form and be willing to complete the study in accordance with the study plan;
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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).
Exclusion Criteria:
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History of SARS-CoV-2 infection(laboratory confirmed);
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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;
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Severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization;
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Autoimmune disease such as systemic lupus erythematosus or immunodeficiency / immunosuppression such as AIDS, post-transplant;
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Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc;
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Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
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Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
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Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
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History of alcohol or drug abuse;
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Receipt of blood products within in the past 3 months;
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Receipt of other investigational drugs in the past 30 days;
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Receipt of other investigational drugs in the past 30 days;
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Receipt of attenuated live vaccines in the past 14 days;
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Acute diseases or acute exacerbation of chronic diseases within 7 days prior to booster vaccination;
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Axillary temperature >37.0°C;
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Already pregnant or are breastfeeding, planning to get pregnant within
1months (according to subjects' self-report and urine pregnancy test results);
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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;
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According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Yanhe Tujia Autonomous County Center for Disease Control and Prevention | Tongren | Guizhou | China | 565300 |
Sponsors and Collaborators
- Sinovac Research and Development Co., Ltd.
Investigators
- Principal Investigator: Qiuyue Mu, Master, Guizhou Provincial Center for Disease Prevention and Control
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-nCOV-4012