Maternal Determinants of Infant Immunity to Pertussis

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The overall objective of the project is to identify the determinants of antibody-mediated immunity in infants born to mothers immunized during pregnancy. Using maternal pertussis immunization as a model, the project will identify key predictors and potential determinants of vaccine responses in pregnant women, of the transfer of maternal antibodies to the newborn and of vaccine responses in infants. A systems biology approach will be used to delineate pre-vaccination and post-vaccination cellular and molecular correlates of the immune response to pertussis immunization in peripheral blood and in breastmilk.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 45
Healthy Volunteers: t
View:

• For non-pregnant \& pregnant women Age between 18 and 45 years Eligible for Tdap vaccination

• For infants Born to mothers vaccinated or not with Tdap Vaccinated with hexavalent vaccine Age between 2 and 3 months

Locations
Other Locations
Belgium
CHU Saint-Pierre
RECRUITING
Brussels
Time Frame
Start Date: 2023-09-12
Estimated Completion Date: 2025-12
Participants
Target number of participants: 200
Treatments
Active_comparator: Pregnant women
Pregnant women will receive one dose of Pertussis-containing vaccine during pregnancy.
Active_comparator: Non pregnant women
Non-Pregnant women will receive one dose of Pertussis-containing vaccine.
Active_comparator: Infants born to Tdap-vaccinated mothers
Infants whose mothers have been immunized during pregnancy with Tdap vaccine. Infants will receive three doses of Pertussis-containing vaccine (with 28 days interval starting at two months of age).
Active_comparator: Infants born to non Tdap-vaccinated mothers
Infants whose mothers have not been immunized during pregnancy with Tdap vaccine.~Infants will receive three doses of Pertussis-containing vaccine (with 28 days interval starting at two months of age).
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire Saint Pierre
Collaborators: Université Libre de Bruxelles

This content was sourced from clinicaltrials.gov