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COVID-19Phase 2NCT06997653

Efficacy, Immunogenicity, and Safety of the Inactivated COVID-19 Vaccine (TURKOVAC) in Healthy Pregnant Women

A Phase 2 study testing TURKOVAC in people with COVID-19 and SARS CoV 2 Infection, run by Health Institutes of Turkey at 1 site in Turkey (Türkiye).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is an open-label and Phase 2b clinical trial of the COVID-19 inactivated TURKOVAC vaccine against SARS-CoV-2 in healthy pregnant women. Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
COVID-19, SARS CoV 2 Infection
What is being tested?
TURKOVAC
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2024to 1 Jan 2024
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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to be eligible for inclusion in the study:
  • Subjects willing and able to give signed informed consent to participate in study,
  • Healthy pregnant female subjects aged 18 - 45 years (including both groups),
  • Females in the second trimester of pregnancy (weeks 13 to 27) and in the third trimester (from week 28 to week 40),
  • Females who were previously vaccinated with two doses of inactivated vaccine also 3 months after their last menstrual period and more than 3 months have passed since they have vaccinated for their last dose,
  • Females without a current positive (real time-polymerase chain reaction (RT-PCR) - based viral RNA (Ribonucleic Acid) detection) or past (serological test or real time-polymerase chain reaction (RT-PCR -based viral RNA (Ribonucleic Acid) detection) positive diagnostic test result for SARS-CoV-2 infection,
  • In the opinion of the investigator, subjects capable and willing to comply with all study requirements,
  • Subjects who agree to comply with all study visits and procedures (who consent to blood and nasopharyngeal swab collection and who can answer automated phone calls from the study center).

Who cannot join

  • Subjects meeting any of the following criteria will be excluded from the study:
  • Subjects with fever (above 37,8°C) at the time of vaccination and/or up to 72 hours before (subjects may be screened again after acute condition has resolved),
  • Possible history of allergic disease or reaction (e.g. to the active substance) by any component of the study vaccines,
  • Any history of anaphylaxis,
  • Subjects with a medical or obstetric history that puts them at higher risk for maternal or fetal complications (e.g. chronic pregnancy-related disorders, birth defects, or genetic conditions during a previous pregnancy),
  • Subjects with an abnormal uterine cavity shown on hysterosalpingography or hysteroscopy,
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  • Subjects with an abnormal pregnancy screening test (e.g. ultrasound fetal abnormalities, maternal blood screening),
  • Subjects with a history of malignancy within 2 years prior to screening (exceptions are squamous, basal cell carcinomas of the skin, carcinomas in situ of the cervix, or malignancy considered treated with minimal risk of recurrence),
  • Females with the presence of hydrosalpinx or endometrial polyp that are not treated surgically,
  • Females with the poor ovarian response (less than 3 mature follicles),
  • Females currently participating in a similar study of another inactive investigational product and currently using this investigational product or who have taken an inactive investigational product in the 28 days before their last menstruation period,
  • In case of clinical necessity, subjects with positive COVID-19 real time-polymerase chain reaction (RT-PCR) test results to be requested from the subjects,
  • Insufficient level of Turkish to perform the informed consent, except where briefing by an independent witness can be provided and is available,
  • 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),
  • 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,
  • 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 (e.g. warfarin) or new oral anticoagulants (e.g. apixaban, rivaroxaban, dabigatran and edoxaban),
  • Subjects with 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,
  • History of active or previous autoimmune neurological disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis) (Lumbar palsy will not be an exclusion criterion),
  • Subjects with severe renal impairment or liver failure,
  • Acute respiratory disease (moderate or severe illness with or without fever). (Subjects may be screened again after acute condition has resolved).

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • T.R. Ministry of Health Ankara City Hospital, Gynecology and Obstetrics Hospital

    Ankara, Turkey, 06800

Other trials in Turkey (Türkiye)

About this study

Official title: Open-Label, Phase 2b Clinical Trial to Determine Efficacy, Safety, and Immunogenicity of Inactivated COVID-19 Vaccine (TURKOVAC) Against SARS-CoV-2 in Healthy Pregnant Women

This study is an open-label and Phase 2b clinical trial of the COVID-19 inactivated TURKOVAC vaccine against SARS-CoV-2 in healthy pregnant women.

Read the detailed description

The main purpose of this study is pregnant women who are at least in the second (13th to 27th weeks) and third (28th to 40th weeks) trimesters, to evaluate of the safety of two doses of TURKOVAC vaccine in who are naive (never vaccinated) and previously vaccinated with two doses of inactivated COVID-19 vaccine.

It is planned to include 30 healthy pregnant subjects between the ages of 18-45 (including both age groups) in the study. After the safety and immunogenicity data obtained from the interim analysis of 30 pregnant female subjects, it will be planned to increase the number of subjects.

Being tested
TURKOVAC
Keywords
COVID-19, SARS-CoV-2 Vaccine, Pregnant Women, 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.

  • TURKOVACBiological

    Inactive COVID-19 Vaccine - TURKOVAC

Study groups in NCT06997653
Study groupRoleWhat they receive
TURKOVACExperimentalTURKOVAC-Dollvet vaccines produced by Dollvet Veterinary Vaccine Pharmaceutical Biological Substance Production Industry Co., Ltd.
Receives: Biological: TURKOVAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events

    Incidence of obstetric, fetal, and neonatal adverse events of TURKOVAC vaccine.

    Measured: Incidence of adverse events throughout the entire study from first and second dose vaccinations.

Secondary outcomes (8)

  1. Neutralizing Antibodies and Pseudo-Neutralizing Antibodies

    The change in the amount of SARS-CoV 2 neutralizing antibodies and pseudo-neutralizing Antibodies in the 28th day compared to the baseline is 2 times and more.

    Measured: On days 0, 28±2 (for all subjects) 48±5, 84±5 ve 168±10 (for 50% of all subjects)

  2. SARS-CoV2 anti-spike protein immunoglobulin G

    The change in the amount of SARS-CoV2 anti-spike protein immunoglobulin G in the 28th day compared to the baseline is 2 times and more.

    Measured: On days 0, 28±2 (for all subjects) 48±5, 84±5 ve 168±10 (for 50% of all subjects)

  3. T-Cell

    IL-2, TNF-alpha, and IFN-gamma levels in T cells changed by 2 times and more on day 28 compared to baseline.

    Measured: On the 28th day

  4. Protection Rate of TURKOVAC

    Protection rate of the TURKOVAC vaccine against COVID-19 in subjects with a positive real time-polymerase chain reaction (RT-PCR) test at least 14 days after the TURKOVAC vaccination and showing at least 1 symptom within 24 hours.

    Measured: 24 hours (subjects with at least 1 symptom within 24 hours) and at least 14 days after the TURKOVAC vaccination dose.

  5. The antibody Level in the Cord Blood

    The antibody level in the cord blood

    Measured: Between Visit 0 (-1 or 0. day) Visit 4 (168 day ±10) (At the time of birth)

  6. Antibody Persistence

    Antibody persistence in mothers at 6 months and 12 months post-vaccination during pregnancy.

    Measured: 6 months and 12 months after vaccination.

  7. Incidence of Adverse Reactions

    Incidence of adverse reactions in all subjects 7 to 14 days after vaccination.

    Measured: 7 to 14 days after vaccination.

  8. Incidence of Serious Adverse Events (SAE)

    Incidence of Serious Adverse Events (SAE) in all subjects up to day 365 after vaccination.

    Measured: Up to day 365 after vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2025
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Jan 2024 (estimated)

Why it stopped: the clinical trial did not initiated

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06997653
Sponsor's protocol ID
TBS-VAC-COV-TUR-GF2B.08
Status last verified
May 2025
First submitted
9 Mar 2022
Last updated
30 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kumar A, Singh R, Kaur J, Pandey S, Sharma V, Thakur L, Sati S, Mani S, Asthana S, Sharma TK, Chaudhuri S, Bhattacharyya S, Kumar N. Wuhan to World: The COVID-19 Pandemic. Front Cell Infect Microbiol. 2021 Mar 30;11:596201. doi: 10.3389/fcimb.2021.596201. eCollection 2021.

    PubMed 33859951

  • Pavel STI, Yetiskin H, Aydin G, Holyavkin C, Uygut MA, Dursun ZB, Celik I, Cevik C, Ozdarendeli A. Isolation and characterization of severe acute respiratory syndrome coronavirus 2 in Turkey. PLoS One. 2020 Sep 16;15(9):e0238614. doi: 10.1371/journal.pone.0238614. eCollection 2020.

    PubMed 32936826

  • Limaye MA, Roman AS, Trostle ME, Venkatesh P, Lantigua Martinez M, Brubaker SG, Chervenak J, Wei LS, Sahani P, Grossman TB, Meyer JA, Penfield CA. Predictors of severe and critical disease in pregnant women with SARS-CoV-2. J Matern Fetal Neonatal Med. 2022 Dec;35(25):7536-7540. doi: 10.1080/14767058.2021.1951216. Epub 2021 Sep 1.

    PubMed 34470122

  • Adhikari EH, Spong CY. COVID-19 Vaccination in Pregnant and Lactating Women. JAMA. 2021 Mar 16;325(11):1039-1040. doi: 10.1001/jama.2021.1658. No abstract available.

    PubMed 33555297

  • Goncu Ayhan S, Oluklu D, Atalay A, Menekse Beser D, Tanacan A, Moraloglu Tekin O, Sahin D. COVID-19 vaccine acceptance in pregnant women. Int J Gynaecol Obstet. 2021 Aug;154(2):291-296. doi: 10.1002/ijgo.13713. Epub 2021 May 1.

    PubMed 33872386

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TURKOVAC in people with COVID-19 and SARS CoV 2 Infection, run by Health Institutes of Turkey at 1 site 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 8 inclusion and 22 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: withdrawn, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.

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?

Incidence of Adverse Events (time frame: Incidence of adverse events throughout the entire study from first and second dose vaccinations.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06997653, which also lists 5 linked publications.

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 30 May 2025.

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