Actively Recruiting
The Optimal Timing of Vaccination in Pregnancy
Led by Elke Leuridan, MD, PhD · Updated on 2024-06-20
96
Participants Needed
1
Research Sites
199 weeks
Total Duration
On this page
Sponsors
E
Elke Leuridan, MD, PhD
Lead Sponsor
U
Université Libre de Bruxelles
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Optimal Timing of Vaccination in Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to provide informed consent
- Willingness to be vaccinated with a Tdap vaccine during pregnancy
- Intention to be available for follow-up visits and phone calls until 6 months postpartum
- Influenza and COVID-19 vaccination during pregnancy allowed as per Belgian recommendations
You will not qualify if you...
- Vaccinated with an acellular pertussis containing vaccine in the last 5 years
- Significant mental illness such as schizophrenia, psychosis, or major depression
- Serious immune system conditions or diseases like HIV infection
- Systemic treatment with immune suppressive medication, including chronic steroid use over 10 mg prednisone or equivalent
- Any condition that, in the investigator's opinion, would prevent completing the study or pose risk
- Previous severe reaction to any vaccine
- High risk for serious obstetrical complications
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vaccinopolis
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
Research Team
K
Kirsten Maertens
CONTACT
E
Elke Leuridan
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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