NCT05856396

Maternal Determinants of Infant Immunity to Pertussis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Centre Hospitalier Universitaire Saint Pierre · Academic / Other
• Sex: All
• Age: 2 Months – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

The overall objective of the project is to identify the determinants of antibody-mediated immunity to pertussis in infants born to mothers immunized during pregnancy. Three specific objectives will be targeted: 1. Determine the impact of pregnancy on the quality of antibody response to pertussis immunization and identify immune predictors of vaccine responses in pregnant and non-pregnant women. 2. Identify immune predictors of the transfer of maternal antibodies to the newborn and the presence of antibody in breastmilk following pertussis immunization during pregnancy. 3. Determine the impact of maternal antibodies on the quality of antibody response to pertussis immunization in infants born to mothers immunized or not immunized during pregnancy and identify immune predictors of vaccine responses in the first months of life. To reach these objectives, 40 non-pregnant and 80 pregnant women will be recruited into the study and vaccinated with a single dose of a pertussis containing vaccine (Triaxis). Blood samples will be collected from: * non-pregnant women: before vaccination, and day 1/7/28 and month 5 post-vaccination. * pregnant women: before vaccination, day 1/7/28 post-vaccination, at delivery, and week 6/12 post-delivery. At week 6/12 post-delivery, breast milk samples will be collected as well. At delivery, a placenta fragment will be collected. In addition, infants 2-3 months old born either from mothers who were not vaccinated against pertussis during pregnancy (n=40) or born from mothers who were vaccinated against pertussis during pregnancy (n=80) will be recruited in the study. Infants will be vaccinated with three doses of a pertussis containing vaccine (Vaxelis), each one month apart starting from 2-3 months of age. Blood samples will be collected from: * infants from vaccinated mothers: cord blood, before 1st vaccine dose, day 1 post 1st vaccine dose, before 3rd vaccine dose, and day 28 post 3rd vaccine dose. * infants from unvaccinated mothers: before 1st vaccine dose, day 1 post 1st vaccine dose, before 3rd vaccine dose, and day 28 post 3rd vaccine dose.

Conditions

• Vaccination; Infection
• Maternal-Fetal Relations
• Pertussis
• Immunoglobulins

Interventions

Type	Name	Description
BIOLOGICAL	Triaxis® (Pertussis-containing vaccine)	Triaxis® (Pertussis-containing vaccine) will be administered: * in non-pregnant women presenting to the Travel and Vaccine clinic for pertussis immunization only or hospital member staff requiring Tetanus Toxoid (TT)-booster immunisation * in Pregnant women between 16 and 29 weeks of gestation.
BIOLOGICAL	Vaxelis® (Pertussis-containing vaccine)	Vaxelis® (Hexavalent vaccine) will be proposed in infants at 8, 12 and 16 weeks of life.

Timeline

• Start date: 2023-09-12
• Primary completion: 2025-12-23
• Completion: 2025-12-23
• First posted: 2023-05-12
• Last updated: 2026-01-13

Locations

1 site across 1 country: Belgium