Safety and Immunogenicity Study of Booster Vaccination in Different Doses of COVID-19 Vaccine (Vero Cell),Inactivated for Prevention of COVID-19

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05165966
• Other study ID #: PRO-nCOV-4010
• Status: Completed
• Phase: Phase 4
• Start date: October 20, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: December 2021
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: July 1, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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
• 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

Locations

Country	Name	City	State
China	Beijing Youan Hospital Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Life Sciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)	GMI of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination
Other	Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)	The seroconversion rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination
Other	Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)	GMT of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination	7 days after the booster dose vaccination
Other	Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)	Seropositivity rate of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination	7 days after the booster dose vaccination
Other	Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)	GMI of neutralizing antibodies(CZ02 strain)7 days after the booster dose vaccination	7 days after the booster dose vaccination
Other	Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)	The seroconversion rate of neutralizing antibodies(CZ02 strain) 7 days after the booster dose vaccination	7 days after the booster dose vaccination
Other	Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)	GMT of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination	28 days after the booster dose vaccination
Other	Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)	Seropositivity rate of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination	28 days after the booster dose vaccination
Other	Immunogenicity index-GMI of neutralizing antibodies(CZ02 strain)	GMI of neutralizing antibodies(CZ02 strain)28 days after the booster dose vaccination	28 days after the booster dose vaccination
Other	Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)	The seroconversion rate of neutralizing antibodies(CZ02 strain) 28 days after the booster dose vaccination	28 days after the booster dose vaccination
Other	Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)	GMT of neutralizing antibodies(CZ02 strain) 3 months after the booster dose vaccination	3 months after the booster dose vaccination
Other	Immunogenicity index-seroconversion rate of neutralizing antibodies(CZ02 strain)	The seroconversion rate of neutralizing antibodies(CZ02 strain)3 months after the booster dose vaccination	3 months after the booster dose vaccination
Other	Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)	GMT of neutralizing antibodies(CZ02 strain) 6 months after the booster dose vaccination	6 months after the booster dose vaccination
Other	Immunogenicity index-GMT of neutralizing antibodies(Delta strain)	GMT of neutralizing antibodies(Delta strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination
Other	Immunogenicity index-Seropositivity rate of neutralizing antibodies(Delta strain)	Seropositivity rate of neutralizing antibodies (Delta strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination
Other	Immunogenicity index-GMI of neutralizing antibodies(Delta strain)	GMI of neutralizing antibodies(Delta strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination
Other	Immunogenicity index-seroconversion rate of neutralizing antibodies(Delta strain)	The seroconversion rate of neutralizing antibodies (Delta strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination
Other	Immunogenicity index-GMT of neutralizing antibodies(Omicron Strain)	GMT of neutralizing antibodies(Omicron Strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination
Other	Immunogenicity index-Seropositivity rate of neutralizing antibodies(Omicron Strain)	Seropositivity rate of neutralizing antibodies (Omicron Strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination
Other	Immunogenicity index-GMI of neutralizing antibodies(Omicron Strain)	GMI of neutralizing antibodies(Omicron Strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination
Other	Immunogenicity index-seroconversion rate of neutralizing antibodies(Omicron Strain)	The seroconversion rate of neutralizing antibodies (Omicron Strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination
Primary	Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)	GMT of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination
Secondary	Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)	Seropositivity rate of neutralizing antibodies(CZ02 strain) 14 days after the booster dose vaccination	14 days after the booster dose vaccination