Back to resultsImmunogenicity，Safety and Cross - Immune Response With Mutant Strains of a Third Dose of an Inactivated COVID-19 Vaccine
Primary Purpose
COVID-19
Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Inactivated COVID-19 Vaccine
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Participated in the clinical studies on the safety and immunogenicity of Inactivated COVID-19 Vaccine combined immunization with 23-valent pneumococcal polysaccharide vaccine in Rushan city, Shandong Province from July to October 2021;
- The interval between complete immunization with two doses of COVID-19 vaccine is 6-8 months;
- Subjects will be willing to participate in the study and follow the study procedure to collect venous blood;
- Proven legal identity;
Exclusion Criteria:
- History of asthma, history of allergy to the vaccine or vaccine components,or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
- Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
- Fever at the time of vaccination, or acute onset of chronic disease, or uncontrolled severe chronic disease, or acute disease;
- Pregnancy or lactation;
- Receipt of attenuated live vaccines in the past 14 days;
- Receipt of inactivated or subunit vaccines in the past 7 days
- According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Sites / Locations
- Rushan City Center for Disease Control and Prevention
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Adult group
Elderly group
Arm Description
90 subjects aged 18-59 years received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine.
90 elderly aged 60 year and older received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine.
Outcomes
Primary Outcome Measures
Seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2
The seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Secondary Outcome Measures
Seropositive rate of neutralizing antibody against Prototype SARS-CoV-2
The seropositive rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
GMT of neutralizing antibody against Prototype SARS-CoV-2
The GMT of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
GMI of neutralizing antibody against Prototype SARS-CoV-2
The GMI of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Seroconversion rate of neutralizing antibody against SARS-CoV-2 strains
The seroconversion rate of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Seropositive rate of neutralizing antibody against SARS-CoV-2 strains
The seropositive rate of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
GMI of neutralizing antibody against SARS-CoV-2 strains
The GMI of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
GMT of neutralizing antibody against SARS-CoV-2 strains
The GMT of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Seropositive rate of antibody against hepatitis A
Seropositive rate of antibody against hepatitis A 6-8 months after vaccination of Hepatitis A vaccine.
GMC of antibody against hepatitis A
GMC of antibody against hepatitis A 6-8 months after vaccination of Hepatitis A vaccine.
Incidence rate of adverse reactions
Incidence rate of adverse reactions within 0-28 days after booster immunization with COVID-19 vaccine.
Full Information
NCT ID
NCT05329038
First Posted
April 12, 2022
Last Updated
July 11, 2022
Sponsor
Sinovac Life Sciences Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05329038
Brief Title
Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of a Third Dose of an Inactivated COVID-19 Vaccine
Official Title
Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of the Third Dose Using Inactivated COVID-19 Vaccine in Population Aged 18 Years and Above
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 19, 2022 (Actual)
Primary Completion Date
June 19, 2022 (Actual)
Study Completion Date
April 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sinovac Life Sciences 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 phase Ⅳ follow-up clinical trial based on the previous Phase Ⅳ clinical trial of an inactivated COVID-19 vaccine (CoronaVac) manufactured by Sinovac Life Sciences Co., Ltd.The purpose of this study is to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine,to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older.
Detailed Description
This study is a phase 4 clinical trial to evaluate the immunogenicity,safety and cross-immune response of booster immunization using COVID-19 vaccine，to compare the similarities and differences of immune responses between primary immunization and booster immunization and to detect antibody against hepatitis A and evaluate the immune persistence of the one dose immunization schedule of hepatitis A vaccine in healthy population aged 18 years and older. The experimental vaccine is manufactured by Sinovac Life Sciences Co., Ltd.. A total of 180 healthy subjects received two dose of inactivated COVID-19 vaccine (CoronaVac) based on primary immunization in previous Phase Ⅳ clinical trial will be enrolled, including 90 adults aged 18-59 years and 90 elderly elderly aged 60 years and older.Subjects in each age group will receive the booster immunization of CoronaVac(the third dose) and will be collected blood sample before booster immunization and 14 days after booster immunization.
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
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Adult group
Arm Type
Experimental
Arm Description
90 subjects aged 18-59 years received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine.
Arm Title
Elderly group
Arm Type
Experimental
Arm Description
90 elderly aged 60 year and older received two dose inactivated COVID-19 vaccine in primary immunization will receive the booster immunization (the third dose )of inactivated COVID-19 vaccine.
Intervention Type
Biological
Intervention Name(s)
Inactivated COVID-19 Vaccine
Other Intervention Name(s)
CoronaVac
Intervention Description
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Primary Outcome Measure Information:
Title
Seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2
Description
The seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Time Frame
14 days after the booster immunization of inactivated COVID-19 vaccine
Secondary Outcome Measure Information:
Title
Seropositive rate of neutralizing antibody against Prototype SARS-CoV-2
Description
The seropositive rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Time Frame
14 days after the booster immunization of inactivated COVID-19 vaccine
Title
GMT of neutralizing antibody against Prototype SARS-CoV-2
Description
The GMT of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Time Frame
14 days after the booster immunization of inactivated COVID-19 vaccine
Title
GMI of neutralizing antibody against Prototype SARS-CoV-2
Description
The GMI of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Time Frame
14 days after the booster immunization of inactivated COVID-19 vaccine
Title
Seroconversion rate of neutralizing antibody against SARS-CoV-2 strains
Description
The seroconversion rate of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Time Frame
14 days after the booster immunization of inactivated COVID-19 vaccine
Title
Seropositive rate of neutralizing antibody against SARS-CoV-2 strains
Description
The seropositive rate of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Time Frame
14 days after the booster immunization of inactivated COVID-19 vaccine
Title
GMI of neutralizing antibody against SARS-CoV-2 strains
Description
The GMI of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Time Frame
14 days after the booster immunization of inactivated COVID-19 vaccine
Title
GMT of neutralizing antibody against SARS-CoV-2 strains
Description
The GMT of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
Time Frame
14 days after the booster immunization of inactivated COVID-19 vaccine
Title
Seropositive rate of antibody against hepatitis A
Description
Seropositive rate of antibody against hepatitis A 6-8 months after vaccination of Hepatitis A vaccine.
Time Frame
6-8 months after vaccination of Hepatitis A vaccine
Title
GMC of antibody against hepatitis A
Description
GMC of antibody against hepatitis A 6-8 months after vaccination of Hepatitis A vaccine.
Time Frame
6-8 months after vaccination of Hepatitis A vaccine
Title
Incidence rate of adverse reactions
Description
Incidence rate of adverse reactions within 0-28 days after booster immunization with COVID-19 vaccine.
Time Frame
0-28 days after booster immunization with COVID-19 vaccine.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participated in the clinical studies on the safety and immunogenicity of Inactivated COVID-19 Vaccine combined immunization with 23-valent pneumococcal polysaccharide vaccine in Rushan city, Shandong Province from July to October 2021;
The interval between complete immunization with two doses of COVID-19 vaccine is 6-8 months;
Subjects will be willing to participate in the study and follow the study procedure to collect venous blood;
Proven legal identity;
Exclusion Criteria:
History of asthma, history of allergy to the vaccine or vaccine components,or serious adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Fever at the time of vaccination, or acute onset of chronic disease, or uncontrolled severe chronic disease, or acute disease;
Pregnancy or lactation;
Receipt of attenuated live vaccines in the past 14 days;
Receipt of inactivated or subunit vaccines in the past 7 days
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
Li Zhang, Master
Organizational Affiliation
Shandong Provincial Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rushan City Center for Disease Control and Prevention
City
Weihai
State/Province
Shandong
ZIP/Postal Code
250014
Country
China
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of a Third Dose of an Inactivated COVID-19 Vaccine
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