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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06466629
Other study ID # cev005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2021
Est. completion date April 30, 2025

Study information

Verified date June 2024
Source Universiteit Antwerpen
Contact Kirsten Maertens
Phone +32496717845
Email kirsten.maertens@uantwerpen.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The central aim of this study is to investigate the optimal timing of vaccination in pregnant women. Therefore, pregnant women will be vaccinated against pertussis at different timepoints and blood and breast milk samples will be taken at several timepoints. The main objectives are to assess the impact of timing on humoral and cellular immune responses in pregnant women, on antibody characteristics transferred across the placenta and on transplacental transport efficiency. The impact of maternal pertussis vaccination and timing of maternal pertussis vaccination on breastmilk antibody composition will also be investigated, as well as the impact of vaccination during pregnancy on the mucosal uptake of breastmilk IgA antibodies by the infant respiratory and gastrointestinal tract.


Recruitment information / eligibility

Status Recruiting
Enrollment 96
Est. completion date April 30, 2025
Est. primary completion date October 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ability to provide informed consent. - Willing to be vaccinated with a Tdap vaccine during pregnancy. - Intend to be available for follow-up visits and phone call access until 6 months postpartum. - Influenza and COVID-19 vaccination during pregnancy (as per Belgian recommendations) is allowed. Exclusion Criteria: - Vaccinated with an aP containing vaccine during the last 5 years - Significant mental illness (e.g. schizophrenia, psychosis, major depression) - Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection…). - Systemic treatment with immune suppressive medication, including chronic steroid use of > 10 mg prednisone or equivalent. - Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk. - Previous severe reaction to any vaccine - High risk for serious obstetrical complications.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Triaxis, Sanofi Pasteur
tetanus, diphtheria, acellular pertussis (aP) (Tdap) vaccine

Locations

Country Name City State
Belgium Vaccinopolis Edegem Antwerp

Sponsors (2)

Lead Sponsor Collaborator
Elke Leuridan, MD, PhD Université Libre de Bruxelles

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy. Before Tdap vaccination
Primary Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy. One month after Tdap vaccination
Primary Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy. At delivery
Primary Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in maternal blood after Tdap vaccination at different timings in pregnancy. 6 months postpartum
Secondary Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy. Before Tdap vaccination
Secondary Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy. One month after Tdap vaccination
Secondary Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy. At delivery
Secondary Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy. 6 months postpartum
Secondary Measurement of antibody levels in cord blood at delivery after Tdap vaccination at different timings in pregnancy to calculate the transport of antibodies across the placenta At delivery
Secondary Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in breastmilk after Tdap vaccination at different timings in pregnancy. 6 months postpartum
See also
  Status Clinical Trial Phase
Recruiting NCT04807712 - Pediatric Pertussis in Ambulatory Settings
Completed NCT05234229 - Influenza and Pertussis Vaccination Status of Women in Immediate Postpartum and Caregivers
Completed NCT05461131 - Pertussis Challenge Study in Adults Vaccinated With BPZE1 Phase 2
Recruiting NCT05847322 - Periscope Phase C Bordetella Pertussis Human Challenge Study With Delayed Antibiotic Therapy for 6 Weeks N/A