Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19

A Randomized, Double-Blinded Clinical Trial to Evaluate Additional Dose of Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine in Healthy Individuals Previously Vaccinated With CoronaVac

This is a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine manufactured by manufactured by Sinovac Research & Development Co., Ltd. The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: High-dosage SARS-CoV-2 vaccine; Biological: Medium-dosage SARS-CoV-2 vaccine

Detailed Description

This study a randomized, double-blinded, phase ⅠV clinical trial of SARS-CoV-2 inactivated vaccine .The purpose of this study is to evaluate the safety and immunogenicity of booster vaccination with high-dosage SARS-CoV-2 vaccine in populations who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month.A total of 1200 subjects who have received two-dose Coronavac with 2nd dose vaccinated more than 6 month will be enrolled.All of subjects will be randomly divided into two groups in a 1:1 ratio .Subjects in experimental group will receive high-dosage SARS-CoV-2 inactivated vaccine.Subjects in control group will receive medium-dosage SARS-CoV-2 inactivated vaccine .

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xinqi, Jiangsu, China, 221400
      • Xinqi City Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged 18-59;
• 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 SARS-CoV-2 vaccine(CoronaVac) manufactured by Sinovac Research & Development Co., Ltd at an interval of 21 to 35 days and is currently 6-8 months (180 to 240 days) after the second dose.

Exclusion Criteria:

• History of SARS-CoV-2 infection(laboratory confirmed);
• Have received three and more doses of inactivated SARS-CoV-2 vaccine;
• Severe adverse reactions, such as urticaria, dyspnea, and angioneurotic edema , occurred during the primary immunization;
• 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;
• Already pregnant or are breastfeeding, planning to get pregnant within 1months (according to subjects' self-report and urine pregnancy test results);
• Participated in other clinical trials prior to enrollment and during the follow-up 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; 600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine .	Biological: High-dosage SARS-CoV-2 vaccine; SARS-CoV-2 Inactivated Vaccine 1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection; Other Names: CoronaVac
Active Comparator: Control Group; 600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine .	Biological: Medium-dosage SARS-CoV-2 vaccine; SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection; Other Names: 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） 28 days after booster vaccination.	Day 28 after booster vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity index-seropositive rate of neutralizing antibodies（CZ02 strain）	The seropositive rate of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination	Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies（CZ02 strain）	The seroconversion rate of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination	Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies（CZ02 strain）	GMI of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination	Day 28 after booster vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies（Delta Strain）	The seropositive rate of neutralizing antibodies（Delta Strain） 28 days after booster vaccination	Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies（Delta Strain）	The seroconversion rate of neutralizing antibodies（Delta Strain） 28 days after booster vaccination	Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies（Delta Strain）	GMI of neutralizing antibodies（Delta Strain） 28 days after booster vaccination	Day 28 after booster vaccination
Immunogenicity index-seroconversion rate of neutralizing antibodies（Omicron Strain）	The seroconversion rate of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination	Day 28 after booster vaccination
Immunogenicity index-seropositive rate of neutralizing antibodies（Omicron Strain）	The seropositive rate of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination	Day 28 after booster vaccination
Immunogenicity index-GMI of neutralizing antibodies（Omicron Strain）	GMI of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination	Day 28 after booster vaccination
Immunogenicity index-GMT of neutralizing antibodies（Omicron Strain）	GMT of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination	Day 28 after booster vaccination
Immunogenicity index-GMT of neutralizing antibodies（Delta Strain）	GMT of neutralizing antibodies（Delta Strain） 28 days after booster vaccination	Day 28 after booster vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity index-the seropositive rate of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain）	The seroconversion rate of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain） 6 months after the booster vaccination	6 months after the booster vaccination
Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain）	GMI of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain） 6 months after the booster vaccination	6 months after the booster vaccination

Collaborators and Investigators

• Sponsor: Sinovac Biotech Co., Ltd
• Investigators: Principal Investigator: Hongxing Pan, Master, Jiangsu Provincial Center for Disease Prevention and Control

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Actual): December 21, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 13, 2022
• Last Verified: October 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-4007

Drug and device information, study documents

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