Immunogenicity，Safety and Cross - Immune Response With Mutant Strains of a Third Dose of an Inactivated COVID-19 Vaccine

November 5, 2023 updated by: Sinovac Life Sciences Co., Ltd.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Weihai, Shandong, China, 250014
        • Rushan City Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adult group
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.
Biological: Inactivated COVID-19 Vaccine
600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
Other Names:
  • CoronaVac
Experimental: Elderly group
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.
Biological: Inactivated COVID-19 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
Seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2
Time Frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
The seroconversion rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
14 days after the booster immunization of inactivated COVID-19 vaccine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seropositive rate of neutralizing antibody against Prototype SARS-CoV-2
Time Frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
The seropositive rate of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
14 days after the booster immunization of inactivated COVID-19 vaccine
GMT of neutralizing antibody against Prototype SARS-CoV-2
Time Frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
The GMT of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
14 days after the booster immunization of inactivated COVID-19 vaccine
GMI of neutralizing antibody against Prototype SARS-CoV-2
Time Frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
The GMI of neutralizing antibody against Prototype SARS-CoV-2 at 14 days after the booster immunization of inactivated COVID-19 vaccine.
14 days after the booster immunization of inactivated COVID-19 vaccine
Seroconversion rate of neutralizing antibody against SARS-CoV-2 strains
Time Frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
The seroconversion rate of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
14 days after the booster immunization of inactivated COVID-19 vaccine
Seropositive rate of neutralizing antibody against SARS-CoV-2 strains
Time Frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
The seropositive rate of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
14 days after the booster immunization of inactivated COVID-19 vaccine
GMI of neutralizing antibody against SARS-CoV-2 strains
Time Frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
The GMI of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
14 days after the booster immunization of inactivated COVID-19 vaccine
GMT of neutralizing antibody against SARS-CoV-2 strains
Time Frame: 14 days after the booster immunization of inactivated COVID-19 vaccine
The GMT of neutralizing antibody against SARS-CoV-2 strains at 14 days after the booster immunization of inactivated COVID-19 vaccine.
14 days after the booster immunization of inactivated COVID-19 vaccine
Seropositive rate of antibody against hepatitis A
Time Frame: 6-8 months after vaccination of Hepatitis A vaccine
Seropositive rate of antibody against hepatitis A 6-8 months after vaccination of Hepatitis A vaccine.
6-8 months after vaccination of Hepatitis A vaccine
GMC of antibody against hepatitis A
Time Frame: 6-8 months after vaccination of Hepatitis A vaccine
GMC of antibody against hepatitis A 6-8 months after vaccination of Hepatitis A vaccine.
6-8 months after vaccination of Hepatitis A vaccine
Incidence rate of adverse reactions
Time Frame: 0-28 days after booster immunization with COVID-19 vaccine.
Incidence rate of adverse reactions within 0-28 days after booster immunization with COVID-19 vaccine.
0-28 days after booster immunization with COVID-19 vaccine.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinovac Life Sciences Co., Ltd.

Investigators

  • Principal Investigator: Li Zhang, Master, Shandong Provincial Center for Disease Control and Prevention

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2022

Primary Completion (Actual)

June 19, 2022

Study Completion (Estimated)

February 20, 2024

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 5, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-nCOV-MA4009-SD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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