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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinovac Life Sciences Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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