Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated (CoronaVac®) Vaccine in Healthy Adults in Turkey

August 9, 2022 updated by: Sinovac Research and Development Co., Ltd.

A Phase IIb Randomized Double-Blinded Positive Controlled Trial to Evaluate the Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated (CoronaVac®) Vaccine in Healthy Adults Who Have Completed Two Doses of CoronaVac® or the mRNA Vaccine (Comirnaty) in Turkey

This is a randomized, double-blinded, and positive-controlled Phase IIb clinical trial of COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research & Development Co., Ltd.The purpose of this study is to evaluate the immunogenicity of using the high (1200SU) or medium (600SU) dose of CoronaVac® as the booster dose.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Suspended

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 is a randomized, double-blinded, and positive-controlled phaseⅡb clinical trial of 640 participants aged 18 years and above, who have completed 2 doses of inactivated COVID-19 vaccine (CoronaVac®) or mRNA COVID-19 vaccine (Comirnaty) as the primary vaccination. Participants will be enrolled and randomly assigned into two arms at a ratio of 1:1 to receive a booster dose of medium-dose (600SU) or high-dose (1200SU) COVID-19 Vaccine. For those who were vaccinated with CoronaVac®, the booster dose will be given 3-8 months after their second dose. For those who were vaccinated with Comirnaty, the booster dose will be given 6-8 months after their second dose. Each participant will be collected 5.0 ml blood sample before vaccination and 14 days,3 months and 6 months after booster immunization.Immunogenicity assessments will be determined by neutralizing antibodies in all participants.In addition,all participants will be monitored for immediate reactions (within 30 minutes) after the booster dose vaccination, adverse events of special interest (AESIs) and serious adverse events (SAEs) for 12 months after booster dose inoculation. In addition, all participants in will be monitored for local and systemic solicited adverse events (AEs) within 7 days and the unsolicited AEs within 28 days.

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 (Anticipated)

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.
640

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 2

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

  • Turkey
      • Ankara, Turkey, 6800
        • Republic of Turkey Ministry of Health Ankara City Hospital Department of Internal Diseases
      • Ankara, Turkey, 6230
        • Hacettepe University Faculty of Medicine, Department of Internal Diseases / Infectious Diseases and Clinical Microbiology Unit

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults aged 18 years and above, who have received 2 prior doses of inactivated COVID-19 vaccine (CoronaVac®) or mRNA COVID-19 vaccine (Comirnaty), with the second dose given 3-8 months (for CoronaVac® recipients) and 6-8 months (for Comirnaty recipients) prior to the day of booster vaccination in the present study;
  • Antigen rapid testing negative at the day of enrollment on site or with a PCR negative result within 72 hours before enrollment;
  • The participants are able to understand and sign the informed consent voluntarily;
  • Female participants who have a negative pregnancy test on the day of vaccination, and not currently breastfeeding;
  • The participants are planning to be living in Turkey for the following 1 year after attending this study;
  • The participants must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.

Exclusion Criteria:

  • History of confirmed or currently with the infection of SARS-CoV-2 prior to randomization;
  • Any prior administration of another investigational coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
  • Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
  • Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc;
  • Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
  • Receipt of blood/plasma products or immunoglobulins in the past 3 months before vaccination in this study;
  • Participation in other studies involving study intervention within 30 days prior to vaccination in this study;
  • Receipt of attenuated live vaccines in the past 14 days prior to vaccination in this study;
  • Receipt of inactivated or subunit vaccines in the past 7 days prior to vaccination in this study;
  • Acute exacerbation or presentation of stable chronic diseases (including but not limited to asthma, migraine, gastrointestinal disorder, etc.);
  • Acute febrile illness with axillary temperature >37.5°C on the day of vaccination; enrollment could be considered if the fever is absent for 72 hours prior to vaccination;
  • According to the investigator's judgment, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk to the participant due to participation in the study.

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: Double

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: Two doses CoronaVac® + one dose medium-dose CoronaVac®
200 participants who were vaccinated with CoronaVac® will be given one dose booster immunization using medium-dose CoronaVac®3-8 months after their second dose
Biological: Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated
Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
  • Medium-dose CoronaVac®
Experimental: Two doses CoronaVac® + one dose high-dose CoronaVac®
200 participants who were vaccinated with CoronaVac® will be given one dose booster immunization using high-dose CoronaVac® 3-8 months after their second dose
Biological: High-dose COVID-19 Vaccine(Vero Cell),Inactivated
High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
  • High-dose CoronaVac®
Experimental: Two doses Comirnaty + one dose medium-dose CoronaVac®
120 participants were vaccinated with Comirnaty will be given one dose booster immunization using medium-dose CoronaVac® 6-8 months after their second dose
Biological: Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated
Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
  • Medium-dose CoronaVac®
Experimental: Two doses Comirnaty + one dose high-dose CoronaVac®
120 participants were vaccinated with Comirnaty will be given one dose booster immunization using one dose high-dose CoronaVac® 6-8 months after their second dose
Biological: High-dose COVID-19 Vaccine(Vero Cell),Inactivated
High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
Other Names:
  • High-dose 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
Immunogenicity index-GMT of neutralizing antibodies
Time Frame: 14 days (14-28 days) after the booster dose vaccination
GMT of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination
14 days (14-28 days) after the booster dose vaccination

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
Immunogenicity index-Seropositivity rate of neutralizing antibodies
Time Frame: 14 days (14-28 days) after the booster dose vaccination
Seropositivity rate of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination
14 days (14-28 days) after the booster dose vaccination
Immunogenicity index-GMI of neutralizing antibodies
Time Frame: 14 days (14-28 days) after the booster dose vaccination
GMI of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination
14 days (14-28 days) after the booster dose vaccination
Immunogenicity index-The seropositivity rate of neutralizing antibody
Time Frame: At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
Seropositivity rate of neutralizing antibody at 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
Immunogenicity index-GMT of neutralizing antibody
Time Frame: At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
GMT of neutralizing antibody at 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination
Safety index-Occurrence, intensity, duration, and relationship of solicited local and systemic AEs
Time Frame: 7 days following the booster dose vaccination
Occurrence, intensity, duration, and relationship of solicited local and systemic AEs for 7 days following the booster dose vaccination
7 days following the booster dose vaccination
Safety index-Occurrence, intensity, duration, and relationship of unsolicited AEs
Time Frame: 28 days post booster vaccination
Occurrence, intensity, duration, and relationship of unsolicited AEs for 28 days post booster vaccination
28 days post booster vaccination
Safety index-Occurrence and relationship of SAEs
Time Frame: From the booster dose to 12 months post booster vaccination
Occurrence and relationship of SAEs (from the booster dose to 12 months post booster vaccination)
From the booster dose to 12 months post booster vaccination
Safety index-Occurrence and relationship of AESI
Time Frame: From the booster dose to 12 months post booster vaccination
Occurrence and relationship of AESI (from the booster dose to 12 months post booster vaccination)
From the booster dose to 12 months post booster vaccination

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Immunogenicity index-The seropositivity rate of neutralizing antibodies
Time Frame: Before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination
The seropositivity rate of neutralizing antibodies before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination
Before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination
Immunogenicity index-GMT of neutralizing antibodies
Time Frame: Before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination
GMT of neutralizing antibodies before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination
Before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination
Immunogenicity index-GMI of neutralizing antibodies
Time Frame: Before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination
GMI of neutralizing antibodies before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination
Before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination

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 Research and Development 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: Enes Seyda Şahiner, Doctor, Republic of Turkey Ministry of Health Ankara City Hospital Department of Internal Diseases

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 (Anticipated)

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.
December 15, 2022

Primary Completion (Anticipated)

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.
January 15, 2023

Study Completion (Anticipated)

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.
January 15, 2023

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).
November 25, 2021

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.
November 25, 2021

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.
December 9, 2021

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.
August 11, 2022

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.
August 9, 2022

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, 2021

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-2002

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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