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Phase 2b Booster Vaccination (TURKOVAC) Against COVID-19 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Phase 2b Booster Vaccination (TURKOVAC) Against COVID-19

Open-Label, Two Arms, Multi-Centered, Phase 2b Clinical Trial to Determine the Safety, Efficacy, and Immunogenicity of Booster Vaccination (TURKOVAC) Against SARS-CoV-2

NCT05210179•Health Institutes of Turkey

View on ClinicalTrials.gov

Summary

This study is open-label, two arms, multi-centered, phase 2b clinical trial to determine the efficacy, safety, and immunogenicity of booster vaccination (TURKOVAC) against Covid-19. The primary aim of the study is to evaluate the efficacy of a booster dose of TURKOVAC vaccine administered to subjects who have passed at least 90 days and at most 240 days after the second dose of the first course of Comirnaty (Code name: BNT162b2) vaccine.

Detailed Description

This phase 2b study aims to determine the efficacy, safety, and immunogenicity of a booster dose of TURKOVAC vaccine administered to subjects who have passed at least 90 days and at most 240 days after the second dose of the first course of Comirnaty (Code name: BNT162b2) vaccine. Efficacy will be evaluated by spike-specific antibody response and neutralizing antibody levels on days 0, 28 (all subjects), 48, 84 and 168 days (50% of subjects). For the booster dose, subjects will be assigned open-label according to randomization (1:1) for 2 different arms. Comparing the efficacy, safety, and immunogenicity results of different series of TURKOVAC vaccines (TURKOVAC-Koçak and TURKOVAC-Dollvet) produced in different production facilities are the secondary objectives of the study. The booster dose vaccine arms are as follows: * TURKOVAC-Koçak * TURKOVAC-Dollvet

Eligibility

Age

18 - 59 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects willing and able to give signed informed consent to participate in study,
•2. Healthy male or female aged 18 - 59 years (including both groups),
•3. Subjects who were vaccinated with Comirnaty (Code name: BNT162b2) for 2 doses and who had a minimum of 90 days and a maximum of 240 days after the second dose,
•4. Subjects with a minimum of 28 days and a maximum of 42 days between 1st and 2nd dose of Comirnaty (Code name: BNT162b2) vaccines,
•5. Female subjects of childbearing potential and male subjects of to have child potential who are willing to ensure that they or their partner use effective contraception continuously from 1 month before vaccination to 3 months after booster vaccination,
•6. In the opinion of the investigator, subjects capable and willing to comply with all study requirements,
•7. Subjects are willing to agree to abstain from donating blood during the study.

Exclusion Criteria

•1. 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),
•2. Known history of SARS-CoV-2 infection,
•3. Pre-or planned use of another vaccine or product likely to affect the study (e.g. adenovirus vectored vaccines, any coronavirus vaccine),
•4. 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,
•5. Subjects with fever (above 38°C) at the time of vaccination and/or up to 72 hours before (subjects may be screened again after acute condition has resolved),
•6. Administration of immunoglobulins and/or any blood product within 3 months prior to vaccination,
•7. 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,
•8. Possible history of allergic disease or reaction (e.g. to the active substance) by any component of the study vaccines,
•9. Any history of anaphylaxis,
•10. Current cancer diagnosis or treatment (excluding basal cell carcinoma of the skin and cervical carcinoma in situ),
+15 more criteria

Locations (9)

T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic

Ankara, Turkey (Türkiye)

University of Health Sciences, Antalya Training and Research Hospital, Family Medicine Clinic

Antalya, Turkey (Türkiye)

Abant İzzet Baysal University Izzet Baysal Training and Research Hospital

Bolu, Turkey (Türkiye)

İstanbul University Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology

Istanbul, Turkey (Türkiye)

T.R. Ministry of Health Başakşehir Çam ve Sakura City Hospital, Clinical Microbiology Clinic

Istanbul, Turkey (Türkiye)

T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Infectious Diseases and Clinical Microbiology Clinic

Istanbul, Turkey (Türkiye)

T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases

Izmir, Turkey (Türkiye)

T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department

Kayseri, Turkey (Türkiye)

University of Health Sciences, Derince Training and Research Hospital, Department of Infectious Diseases and Clinical Microbiology

Kocaeli, Turkey (Türkiye)

Key Dates

Start Date

January 24, 2022

Primary Completion Date

February 25, 2023

Completion Date

May 2, 2023

Last Updated

November 29, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19Sars-CoV-2 Infection

Interventions

TURKOVAC-Dollvet

BIOLOGICAL

TURKOVAC-Koçak

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 2b Booster Vaccination (TURKOVAC) Against COVID-19

Inclusion Criteria

Exclusion Criteria

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