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

Primary Purpose

COVID-19

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
High-dosage SARS-CoV-2 vaccine
Medium-dosage SARS-CoV-2 vaccine
Sponsored by
Sinovac Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Xinqi City Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Group

Control Group

Arm Description

600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine .

600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine .

Outcomes

Primary Outcome Measures

Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain）
GMT of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination.

Secondary Outcome Measures

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

Full Information

First Posted
October 14, 2021
Last Updated
February 13, 2022
Sponsor
Sinovac Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05079217
Brief Title
Safety and Immunogenicity Study of Booster Vaccination With Medium-dosage or High-dosage SARS-CoV-2 Inactivated Vaccine for Prevention of COVID-19
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
600 participants will receive one dose of booster vaccination with high-dosage inactivated SARS-CoV-2 vaccine .
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
600 participants will receive one dose of booster vaccination with medium-dosage inactivated SARS-CoV-2 vaccine .
Intervention Type
Biological
Intervention Name(s)
High-dosage SARS-CoV-2 vaccine
Other Intervention Name(s)
CoronaVac
Intervention Description
SARS-CoV-2 Inactivated Vaccine 1200SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Intervention Type
Biological
Intervention Name(s)
Medium-dosage SARS-CoV-2 vaccine
Other Intervention Name(s)
CoronaVac
Intervention Description
SARS-CoV-2 Inactivated Vaccine 600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
Primary Outcome Measure Information:
Title
Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain）
Description
GMT of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination.
Time Frame
Day 28 after booster vaccination
Secondary Outcome Measure Information:
Title
Immunogenicity index-seropositive rate of neutralizing antibodies（CZ02 strain）
Description
The seropositive rate of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination
Time Frame
Day 28 after booster vaccination
Title
Immunogenicity index-seroconversion rate of neutralizing antibodies（CZ02 strain）
Description
The seroconversion rate of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination
Time Frame
Day 28 after booster vaccination
Title
Immunogenicity index-GMI of neutralizing antibodies（CZ02 strain）
Description
GMI of neutralizing antibodies（CZ02 strain） 28 days after booster vaccination
Time Frame
Day 28 after booster vaccination
Title
Immunogenicity index-seropositive rate of neutralizing antibodies（Delta Strain）
Description
The seropositive rate of neutralizing antibodies（Delta Strain） 28 days after booster vaccination
Time Frame
Day 28 after booster vaccination
Title
Immunogenicity index-seroconversion rate of neutralizing antibodies（Delta Strain）
Description
The seroconversion rate of neutralizing antibodies（Delta Strain） 28 days after booster vaccination
Time Frame
Day 28 after booster vaccination
Title
Immunogenicity index-GMI of neutralizing antibodies（Delta Strain）
Description
GMI of neutralizing antibodies（Delta Strain） 28 days after booster vaccination
Time Frame
Day 28 after booster vaccination
Title
Immunogenicity index-seroconversion rate of neutralizing antibodies（Omicron Strain）
Description
The seroconversion rate of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
Time Frame
Day 28 after booster vaccination
Title
Immunogenicity index-seropositive rate of neutralizing antibodies（Omicron Strain）
Description
The seropositive rate of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
Time Frame
Day 28 after booster vaccination
Title
Immunogenicity index-GMI of neutralizing antibodies（Omicron Strain）
Description
GMI of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
Time Frame
Day 28 after booster vaccination
Title
Immunogenicity index-GMT of neutralizing antibodies（Omicron Strain）
Description
GMT of neutralizing antibodies（Omicron Strain） 28 days after booster vaccination
Time Frame
Day 28 after booster vaccination
Title
Immunogenicity index-GMT of neutralizing antibodies（Delta Strain）
Description
GMT of neutralizing antibodies（Delta Strain） 28 days after booster vaccination
Time Frame
Day 28 after booster vaccination
Other Pre-specified Outcome Measures:
Title
Immunogenicity index-the seropositive rate of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain）
Description
The seroconversion rate of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain） 6 months after the booster vaccination
Time Frame
6 months after the booster vaccination
Title
Immunogenicity index-GMT of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain）
Description
GMI of neutralizing antibodies（CZ02 strain,Delta Strain and Omicron Strain） 6 months after the booster vaccination
Time Frame
6 months after the booster vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongxing Pan, Master
Organizational Affiliation
Jiangsu Provincial Center for Disease Prevention and Control
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinqi City Center for Disease Control and Prevention
City
Xinqi
State/Province
Jiangsu
ZIP/Postal Code
221400
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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