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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
65
TURKOVAC-Dollvet vaccines produced by Dollvet Veterinary Vaccine Pharmaceutical Biological Substance Production Industry Co., Ltd.
TURKOVAC-Koçak vaccines produced by Koçak Farma Pharmaceutical and Chemical Industry Co., Ltd.
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)
Neutralizing Antibodies
The change in the level of SARS-CoV2 Neutralizing Antibodies in the 28th day compared to the baseline
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: On days 0 and 28
Rates of subjects who have been found to be positive for COVID-19
Rates of subjects who have been found to be positive for COVID-19 by RT-PCR (real time polymerase chain reaction) test after administration of TURKOVAC vaccine. (On day 0 and it will be repeated if the subject develops symptoms during the follow-up period)
Time frame: On day 0
Incidence of Adverse Reaction
Incidence of adverse reactions within 7 days of vaccination in all subjects. (Within 7 days of booster vaccination)
Time frame: Within 7 days of booster vaccination
Incidence of Serious Adverse Events (SAE)
Incidence of Serious Adverse Events (SAE) up to day 168 after vaccination in all subjects.
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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)
Time frame: Up to day 168 after booster vaccination