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

NCT05210179 | Completed Phase 2 DMC

• 1 other identifier: TSB-VAC-COV-TUR-RF2B.05
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

COVID-19; Sars-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2 Vaccine; Booster; Efficacy; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (4)

• Neutralizing Antibodies

  The change in the level of SARS-CoV2 Neutralizing Antibodies in the 28th day compared to the baseline

  On days 0 and 28

• Pseudo-Neutralizing Antibodies

  The change in the level of SARS-CoV2 Pseudo-Neutralizing Antibodies in the 28th day compared to the baseline

  On days 0 and 28

• Anti-spike protein immunoglobulin G

  The change in the level of SARS-CoV2 anti-spike protein immunoglobulin G in the 28th day compared to the baseline

  On days 0 and 28

• T Cell Responses

  The change in the level of T Cell Responses in the 28th day compared to the baseline

  On days 0 and 28

Secondary Outcomes (3)

• Rates of subjects who have been found to be positive for COVID-19

  On day 0

• Incidence of Adverse Reaction

  Within 7 days of booster vaccination

• Incidence of Serious Adverse Events (SAE)

  Up to day 168 after booster vaccination

Study Arms (2)

TURKOVAC-Koçak

ACTIVE COMPARATOR

The dose of the TURKOVAC vaccine will be 3 μg/0.5 mL and will be administered by injection into the deltoid muscle.

Biological: TURKOVAC-Koçak

TURKOVAC-Dollvet

ACTIVE COMPARATOR

The dose of the TURKOVAC vaccine will be 3 μg/0.5 mL and will be administered by injection into the deltoid muscle.

Biological: TURKOVAC-Dollvet

Interventions

TURKOVAC-Dollvet BIOLOGICAL

TURKOVAC-Dollvet vaccines produced by Dollvet Veterinary Vaccine Pharmaceutical Biological Substance Production Industry Co., Ltd.

TURKOVAC-Dollvet

TURKOVAC-Koçak BIOLOGICAL

TURKOVAC-Koçak vaccines produced by Koçak Farma Pharmaceutical and Chemical Industry Co., Ltd.

TURKOVAC-Koçak

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects willing and able to give signed informed consent to participate in study,
• Healthy male or female aged 18 - 59 years (including both groups),
• 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,
• Subjects with a minimum of 28 days and a maximum of 42 days between 1st and 2nd dose of Comirnaty (Code name: BNT162b2) vaccines,
• 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,
• In the opinion of the investigator, subjects capable and willing to comply with all study requirements,
• Subjects are willing to agree to abstain from donating blood during the study.

You may not qualify if:

• 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),
• Known history of SARS-CoV-2 infection,
• 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 (subjects may be screened again after acute condition has resolved),
• 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 (e.g. 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),

Sponsors & Collaborators

• Health Institutes of Turkey: lead

Study Sites (9)

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

Ankara, 06800, Turkey (Türkiye)

Location

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

Antalya, Turkey (Türkiye)

Location

Abant İzzet Baysal University Izzet Baysal Training and Research Hospital

Bolu, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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

Izmir, 35180, Turkey (Türkiye)

Location

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

Kayseri, Turkey (Türkiye)

Location

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

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bedia Dinç, Assoc. Prof.

  Faculty Member

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: National, 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

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: January 27, 2022
• Study Start: January 24, 2022
• Primary Completion: February 25, 2023
• Study Completion: May 2, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-02

Locations

TU (9)