NCT06466629

The Optimal Timing of Vaccination in Pregnancy

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 96 (estimated)
• Sponsor: Elke Leuridan, MD, PhD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pertussis/Whooping Cough

Interventions

Type	Name	Description
BIOLOGICAL	Triaxis, Sanofi Pasteur	tetanus, diphtheria, acellular pertussis (aP) (Tdap) vaccine

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-10-31
• Completion: 2025-04-30
• First posted: 2024-06-20
• Last updated: 2024-06-20

Locations

1 site across 1 country: Belgium