COVID-19Phase 2NCT05210179
Phase 2b Booster Vaccination (TURKOVAC) Against COVID-19
A Phase 2 study testing TURKOVAC-Dollvet and TURKOVAC-Koçak in people with COVID-19 and Sars-CoV-2 Infection, run by Health Institutes of Turkey at 9 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Sars-CoV-2 Infection
- What is being tested?
- TURKOVAC-Dollvet and TURKOVAC-Koçak
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 9 sitesTurkey (Türkiye)
- Study dates
- 24 Jan 2022to 2 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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),
- 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 (greater than 37.8°C as measured by ear) (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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Turkey (Türkiye)9 sites
T.R. Ministry of Health Ankara City Hospital, Infectious Diseases and Clinical Microbiology Clinic
Ankara, 06800
University of Health Sciences, Antalya Training and Research Hospital, Family Medicine Clinic
Antalya
Abant İzzet Baysal University Izzet Baysal Training and Research Hospital
Bolu
İstanbul University Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Internal Medicine - Department of Infectious Diseases and Clinical Microbiology
Istanbul
T.R. Ministry of Health Başakşehir Çam ve Sakura City Hospital, Clinical Microbiology Clinic
Istanbul
T.R. Ministry of Health Istanbul Provincial Health Directorate Prof. Dr. Cemil Taşçıoğlu City Hospital, Infectious Diseases and Clinical Microbiology Clinic
Istanbul
T.R. Ministry of Health İzmir Provincial Health Directorate İzmir Health Sciences University Tepecik Training and Research Hospital, Infectious Diseases
Izmir, 35180
T.R. Ministry of Health Kayseri City Training and Research Hospital, Infectious Diseases and Clinical Microbiology Department
Kayseri
University of Health Sciences, Derince Training and Research Hospital, Department of Infectious Diseases and Clinical Microbiology
Kocaeli
About this study
Official title: 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
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.
Read the 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
- Conditions
- COVID-19, Sars-CoV-2 Infection
- Being tested
- TURKOVAC-Dollvet, TURKOVAC-Koçak
- Keywords
- COVID-19, SARS-CoV-2 Vaccine, Booster, Efficacy, Immunogenicity, Safety
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURKOVAC-DollvetBiological
TURKOVAC-Dollvet vaccines produced by Dollvet Veterinary Vaccine Pharmaceutical Biological Substance Production Industry Co., Ltd.
TURKOVAC-KoçakBiological
TURKOVAC-Koçak vaccines produced by Koçak Farma Pharmaceutical and Chemical Industry Co., Ltd.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: TURKOVAC-Dollvet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing Antibodies
The change in the level of SARS-CoV2 Neutralizing Antibodies in the 28th day compared to the baseline
Measured: 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
Measured: 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
Measured: 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
Measured: On days 0 and 28
Secondary outcomes (3)
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)
Measured: 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)
Measured: 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.
Measured: Up to day 168 after booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start24 Jan 2022
- Primary completion25 Feb 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Institutes of Turkey
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Bedia Dinç, Assoc. Prof., Principal investigator, Faculty Member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210179
- Sponsor's protocol ID
- TSB-VAC-COV-TUR-RF2B.05
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05210179
- Acronym / sponsor ID
- TSB-VAC-COV-TUR-RF2B.05
- Conditions
- COVID-19, Sars-CoV-2 Infection
- Keywords
- COVID-19, SARS-CoV-2 Vaccine, Booster, Efficacy, Immunogenicity, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Health Institutes of TurkeyOther government
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 25 Feb 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| TURKOVAC-Koçak | Active comparator | Biological: TURKOVAC-KoçakThe dose of the TURKOVAC vaccine will be 3 μg/0.5 mL and will be administered by injection into the deltoid muscle. |
| TURKOVAC-Dollvet | Active comparator | Biological: TURKOVAC-DollvetThe dose of the TURKOVAC vaccine will be 3 μg/0.5 mL and will be administered by injection into the deltoid muscle. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (25 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TURKOVAC-DollvetTURKOVAC-Dollvet vaccines produced by Dollvet Veterinary Vaccine Pharmaceutical Biological Substance Production Industry Co., Ltd. | Biological | TURKOVAC-Dollvet |
| TURKOVAC-KoçakTURKOVAC-Koçak vaccines produced by Koçak Farma Pharmaceutical and Chemical Industry Co., Ltd. | Biological | TURKOVAC-Koçak |
Primary outcome
Neutralizing Antibodies
Time frame: On days 0 and 28
The change in the level of SARS-CoV2 Neutralizing Antibodies in the 28th day compared to the baseline
Pseudo-Neutralizing Antibodies
Time frame: On days 0 and 28
The change in the level of SARS-CoV2 Pseudo-Neutralizing Antibodies in the 28th day compared to the baseline
Anti-spike protein immunoglobulin G
Time frame: On days 0 and 28
The change in the level of SARS-CoV2 anti-spike protein immunoglobulin G in the 28th day compared to the baseline
T Cell Responses
Time frame: On days 0 and 28
The change in the level of T Cell Responses in the 28th day compared to the baseline
3 secondary outcomes
Rates of subjects who have been found to be positive for COVID-19
Time frame: On day 0
Incidence of Adverse Reaction
Time frame: Within 7 days of booster vaccination
Incidence of Serious Adverse Events (SAE)
Time frame: Up to day 168 after booster vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bedia Dinç, Assoc. Prof. principal investigator
Faculty Member
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TURKOVAC-Dollvet and TURKOVAC-Koçak in people with COVID-19 and Sars-CoV-2 Infection, run by Health Institutes of Turkey at 9 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutralizing Antibodies (time frame: On days 0 and 28). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.