Booster Vaccination Against COVID-19

November 28, 2023 updated by: Health Institutes of Turkey

Double-Blind, Randomized, Controlled, Multi-Centered, Phase 2 Clinical Trial to Determine the Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2

A booster dose of vaccine (Turkovac or CoronaVac) will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To determine the safety and immunogenicity of booster doses of vaccine against SARS-CoV2 after a minimum of 90 days and a maximum of 270 days after the 2nd dose of a homologous 2 dose primary regimen.

It is planned to recruit 111 subjects for 2 vaccines (Turkovac and CoronaVac). There will be a total of 222 subjects.

Study Type

Interventional

Enrollment (Actual)

222

Phase

  • 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
        • Ankara City Hospital Internal Medicine Clinic
      • Istanbul, Turkey
        • Sancaktepe Martyr Professor Dr. İlhan Varank Training and Research Hospital Infectious Diseases and Clinical Microbiology Clinic
      • Istanbul, Turkey
        • T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases
      • Istanbul, Turkey
        • Ümraniye Training and Research Hospital Infectious Diseases

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 to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Signed informed consent
  • Healthy male or female aged 18 - 60 years (including both groups)
  • Subjects who were vaccinated with CoronaVac for 2 doses and who had a minimum of 90 days and a maximum of 270 days after the second dose
  • Subjects may have a controlled or moderate comorbidity
  • Female subjects of childbearing potential should be willing to ensure that they or their partner use effective birth control methods continuously from 1 month before and up to 3 months after vaccination
  • Subjects agreed to comply with all study requirements
  • Subjects are willing to share their medical history with their physician and allow access to all medical records when relevant to study procedures
  • Subjects are willing to agree to abstain from donating blood during the study

Exclusion Criteria:

Subjects meeting any of the following criteria will be excluded from the study:

  • Administration of any vaccine (registered or investigational) other than study intervention within 30 days before and after each study vaccine (one week for authorized seasonal flu vaccine or pneumococcal vaccine)
  • Positive for COVID-19 after primary vaccination
  • Pre-or planned use of another vaccine or product likely to affect the study (e.g. adenovirus vectored vaccines, any coronavirus vaccine)
  • Subjects who were pregnant at the time of enrollment or who plan to become pregnant within the first 3 months following vaccination and who are breastfeeding
  • Subjects with fever (above 38°C) at the time of vaccination and/or up to 72 hours before
  • Administration of immunoglobulins and/or any blood product within 3 months prior to vaccination
  • Any confirmed or suspected immunosuppressive or immunodeficiency state; asplenia; recurrent severe infections and use of immunosuppressants (less than ≤14 days) in the last 6 months, excluding topical steroids or short-term oral steroids
  • Possible history of allergic disease or reaction (e.g. to the active substance) by any component of the study vaccines
  • Any history of anaphylaxis
  • Current cancer diagnosis or treatment (excluding basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture
  • Continued use of anticoagulants such as coumarins and related anticoagulants (i.e. warfarin) or new oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
  • Cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2).
  • Suspected or known current alcohol or drug addiction
  • Any other significant disease, disorder or finding that could significantly increase the subject's risk for participation in the study, affect the subject's ability to participate in the study, or impair the interpretation of study data; severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, kidney disease, endocrine disorder, and neurological disease (mild/moderate well-controlled comorbidities are permitted)
  • History of active or previous autoimmune neurological disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis) (Bell's palsy will not be an exclusion criterion)
  • Subjects with severe renal impairment or liver failure
  • Subjects who will undergo scheduled elective surgery during the study
  • Subjects with a life expectancy of less than 6 months
  • Subject who participated in another clinical trial study involving an investigational product in the past 12 weeks
  • In case of clinical necessity, a COVID-19 PCR (polymerase chain reaction) test will be requested from the subjects, and subjects who are positive will be excluded from the study
  • Known history of SARS-CoV-2 infection
  • Acute respiratory disease (moderate or severe illness with or without fever) (Subjects may be screened again after acute condition has resolved)
  • Fever (oral temperature > 37.8°C) (Subjects can be enrolled again after acute condition improves)
  • Insufficient level of Turkish to perform the informed consent, except where briefing by an independent witness can be provided and is available

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CoronaVac
Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
Biological: CoronaVac
One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.
Experimental: Turkovac
Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
Biological: Turkovac
One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse reactions
Time Frame: 7 days after vaccination
Incidence of adverse reactions within 7 days of vaccination in all subjects
7 days after vaccination
Incidence of Serious Adverse Events (SAE)
Time Frame: 168 days after vaccination
Incidence of Serious Adverse Events (SAE) in all subjects 168 days after vaccination
168 days after vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neutralizing antibody and anti-spike protein immunoglobulin G
Time Frame: On days 0, 28 and 84
Amount of SARS-CoV2 anti-spike protein immunoglobulin G and SARS-CoV2 neutralizing antibody amount
On days 0, 28 and 84

Collaborators and Investigators

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

Sponsor

Health Institutes of Turkey

Investigators

  • Principal Investigator: Ahmet Omma, Assoc. Prof., Faculty Member

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

July 12, 2021

Primary Completion (Actual)

March 9, 2022

Study Completion (Actual)

June 6, 2022

Study Registration Dates

First Submitted

July 15, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

November 29, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hibrid COV-Rapel TR

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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