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

NCT06997653 | Withdrawn Phase 2 DMC

• 1 other identifier: TBS-VAC-COV-TUR-GF2B.08
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19; SARS CoV 2 Infection

Keywords

COVID-19; SARS-CoV-2 Vaccine; Pregnant Women; Efficacy; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

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

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

Secondary Outcomes (8)

• Neutralizing Antibodies and Pseudo-Neutralizing Antibodies

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

• SARS-CoV2 anti-spike protein immunoglobulin G

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

• T-Cell

  On the 28th day

• Protection Rate of TURKOVAC

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

• The antibody Level in the Cord Blood

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

Study Arms (1)

TURKOVAC

EXPERIMENTAL

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

Biological: TURKOVAC

Interventions

TURKOVAC BIOLOGICAL

Inactive COVID-19 Vaccine - TURKOVAC

TURKOVAC

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Healthy pregnant female subjects aged 18 - 45 years (including both groups)
• 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 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).

You may not qualify if:

• 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,
• 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,

Sponsors & Collaborators

• Health Institutes of Turkey: lead

Study Sites (1)

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

Ankara, Turkey, 06800, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 33859951 BACKGROUND

• 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.

  PMID: 32936826 BACKGROUND

• 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.

  PMID: 34470122 BACKGROUND

• 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.

  PMID: 33555297 BACKGROUND

• 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.

  PMID: 33872386 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

TURKOVAC

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

• Özlem Moraloğlu Tekin, Prof.

  Faculty Member

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open-Label, National, Phase IIB Clinical Trial
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: May 30, 2025
• Study Start: January 1, 2024
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)