Investigating the best time for pregnant women to get vaccinated against whooping cough
The Optimal Timing of Vaccination in Pregnancy: a Multi-dimensional Mechanistic Approach to Measure Immune Responses in Pregnant Women
This study is trying to find out the best time for pregnant women to get vaccinated against whooping cough to help protect both mothers and their babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Universiteit Antwerpen Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Edegem, Antwerp) |
| Trial ID | NCT06466629 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the optimal timing for pertussis vaccination in pregnant women by administering the vaccine at various timepoints. Researchers will collect blood and breast milk samples to evaluate the immune responses in mothers and the characteristics of antibodies transferred to the infant. The study will also assess how the timing of vaccination affects the composition of breast milk antibodies and their absorption by the infant's respiratory and gastrointestinal tracts. The findings could provide insights into improving maternal and infant health outcomes related to pertussis.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who are willing to receive a Tdap vaccine and can commit to follow-up visits.
Not a fit: Patients with significant mental illness, serious immunological conditions, or those who have had severe reactions to vaccines may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the effectiveness of pertussis vaccination in pregnant women, leading to better protection for infants.
How similar studies have performed: Other studies have explored vaccination timing in pregnancy, but this specific approach to pertussis vaccination is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Edegem, Antwerp
- Vaccinopolis — Edegem, Antwerp, Belgium (Recruiting)
Study contacts
- Study coordinator: Kirsten Maertens
- Email: kirsten.maertens@uantwerpen.be
- Phone: +32496717845
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.