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

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

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

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: High-dosage of COVID-19 vaccine (Vero cell), Inactivated; Biological: Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated

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 Type: Interventional
• Enrollment (Actual): 340
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100069
      • Beijing Youan Hospital Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: High-dose CoronaVac®
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: Medium-dose CoronaVac®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Sinovac Life Sciences Co., Ltd.
• Investigators: Principal Investigator: Yingmei Feng, Master, Beijing YouAn Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2022
• Last Update Submitted That Met QC Criteria: August 9, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PRO-nCOV-4010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No