Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated 170 participants will receive one dose of booster vaccination with high-dosage of COVID-19 vaccine (Vero cell), Inactivated. |
Biological: High-dosage of COVID-19 vaccine (Vero cell), Inactivated
High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
|
| Experimental: Experimental Group-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated 170 participants will receive one dose of booster vaccination with medium-dosage of COVID-19 vaccine (Vero cell), Inactivated. |
Biological: Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated
Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) [14 days after the booster dose vaccination]
GMT of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
Secondary Outcome Measures
- Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain) [14 days after the booster dose vaccination]
Seropositivity rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
Other Outcome Measures
- Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain) [14 days after the booster dose vaccination]
GMI of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
- Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain) [14 days after the booster dose vaccination]
The seroconversion rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination
- Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) [7 days after the booster dose vaccination]
GMT of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination
- Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain) [7 days after the booster dose vaccination]
Seropositivity rate of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination
- Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain) [7 days after the booster dose vaccination]
GMI of neutralizing antibodies(CZ02 strain)7 days after the booster dose vaccination
- Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain) [7 days after the booster dose vaccination]
The seroconversion rate of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination
- Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) [28 days after the booster dose vaccination]
GMT of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination
- Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain) [28 days after the booster dose vaccination]
Seropositivity rate of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination
- Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain) [28 days after the booster dose vaccination]
GMI of neutralizing antibodies(CZ02 strain)28 days after the booster dose vaccination
- Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain) [28 days after the booster dose vaccination]
The seroconversion rate of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination
- Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) [3 months after the booster dose vaccination]
GMT of neutralizing antibodies(CZ02 strain) 3 months after the booster dose vaccination
- Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain) [3 months after the booster dose vaccination]
The seroconversion rate of neutralizing antibodies(CZ02 strain)3 months after the booster dose vaccination
- Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain) [6 months after the booster dose vaccination]
GMT of neutralizing antibodies(CZ02 strain) 6 months after the booster dose vaccination
- Immunogenicity index-GMT of neutralizing antibodies(Delta strain) [14 days after the booster dose vaccination]
GMT of neutralizing antibodies(Delta strain) 14 days after the booster dose vaccination
- Immunogenicity index-Seropositivity rate of neutralizing antibodies(Delta strain) [14 days after the booster dose vaccination]
Seropositivity rate of neutralizing antibodies (Delta strain) 14 days after the booster dose vaccination
- Immunogenicity index-GMI of neutralizing antibodies(Delta strain) [14 days after the booster dose vaccination]
GMI of neutralizing antibodies(Delta strain) 14 days after the booster dose vaccination
- Immunogenicity index-seroconversion rate of neutralizing antibodies(Delta strain) [14 days after the booster dose vaccination]
The seroconversion rate of neutralizing antibodies (Delta strain) 14 days after the booster dose vaccination
- Immunogenicity index-GMT of neutralizing antibodies(Omicron Strain) [14 days after the booster dose vaccination]
GMT of neutralizing antibodies(Omicron Strain) 14 days after the booster dose vaccination
- Immunogenicity index-Seropositivity rate of neutralizing antibodies(Omicron Strain) [14 days after the booster dose vaccination]
Seropositivity rate of neutralizing antibodies (Omicron Strain) 14 days after the booster dose vaccination
- Immunogenicity index-GMI of neutralizing antibodies(Omicron Strain) [14 days after the booster dose vaccination]
GMI of neutralizing antibodies(Omicron Strain) 14 days after the booster dose vaccination
- Immunogenicity index-seroconversion rate of neutralizing antibodies(Omicron Strain) [14 days after the booster dose vaccination]
The seroconversion rate of neutralizing antibodies (Omicron Strain) 14 days after the booster dose vaccination
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Healthy participants aged 18 years and above;
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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 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:
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History of SARS-CoV-2 infection(laboratory confirmed);
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Have received three and more doses of inactivated COVID-19 vaccine;
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Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
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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 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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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 | |
|---|---|---|---|---|---|
| 1 | Beijing Youan Hospital Capital Medical University | Beijing | Beijing | China | 100069 |
Sponsors and Collaborators
- Sinovac Life Sciences Co., Ltd.
Investigators
- Principal Investigator: Yingmei Feng, Master, Beijing YouAn Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO-nCOV-4010