The Optimal Timing of Vaccination in Pregnancy: a Multi-dimensional Mechanistic Approach to Measure Immune Responses in Pregnant Women

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Belgium
Vaccinopolis
RECRUITING
Edegem
Contact Information
Primary
Kirsten Maertens
kirsten.maertens@uantwerpen.be
+32496717845
Backup
Elke Leuridan
elke.leuridan@uantwerpen.be
032652885
Time Frame
Start Date: 2021-07-01
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 96
Treatments
Cohort 1
Pregnant women vaccinated with Tdap vaccine between 16-18 weeks of gestation
Cohort 2
Pregnant women vaccinated with Tdap vaccine between 25-27 weeks of gestation
Cohort 3
Pregnant women vaccinated with Tdap vaccine between 34-36 weeks of gestation
Related Therapeutic Areas
Sponsors
Leads: Elke Leuridan, MD, PhD
Collaborators: Université Libre de Bruxelles

This content was sourced from clinicaltrials.gov