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

NCT05165966 | Completed Phase 4

• 1 other identifier: PRO-nCOV-4010
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Immunogenicity index-Seropositivity rate of neutralizing antibodies(CZ02 strain)

  14 days after the booster dose vaccination

Other Outcomes (21)

• Immunogenicity index-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

• Immunogenicity index-GMT of neutralizing antibodies(CZ02 strain)

  7 days after the booster dose vaccination

Study Arms (2)

Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated

EXPERIMENTAL

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

Experimental Group-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated

EXPERIMENTAL

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

Interventions

High-dosage of COVID-19 vaccine (Vero cell), Inactivated BIOLOGICAL

High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

Also known as: High-dose CoronaVac®

Experimental Group-High-dosage of COVID-19 vaccine (Vero cell), Inactivated

Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated BIOLOGICAL

Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

Also known as: Medium-dose CoronaVac®

Experimental Group-Medium-dosage of COVID-19 vaccine (Vero cell), Inactivated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Sinovac Life Sciences Co., Ltd.: lead

Study Sites (1)

Beijing Youan Hospital Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yingmei Feng, Master

  Beijing YouAn Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: December 21, 2021
• Study Start: October 20, 2021
• Primary Completion: April 20, 2022
• Study Completion: July 1, 2022
• Last Updated: August 11, 2022

Record last verified: 2021-12

Locations

CN (1)