Maternal Determinants of Infant Immunity to Pertussis

B0762022220909

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.

2023-06-01

2024-12-01

2025-12-01

Not yet recruiting

Early phase I

200

Inclusion Criteria: * 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 Exclusion Criteria: * For pregnant and non-pregnant women * Inability to understand the nature and extent of the study and the procedures required * Grade III/IV anemia, * Acute infection at the time of immunization * Chronic infections such as Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV) infection, acute toxoplasmosis * Current or recent use of immunosuppressive drugs * Active neoplasia * Other vaccine(s) administered at the same time as Tdap vaccination (wash out of 3 weeks after others vaccinations and 28 days after Tdap vaccination ) * For pregnant women * Risk of premature delivery or intrauterine growth retardation * Twin or triplet pregnancies * For non-pregnant women Last Tdap vaccination \< 12 months before For infants: * Infants born before 35 weeks of gestation * Birthweight below 2.5 kg, * Severe neonatal distress * Serious congenital abnormalities or congenital infection.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* Non pregnant and pregnant women will be recruited in parallel\n* Infants born to Tdap vaccinated-mothers (enrolled or not in the study) or not vaccinated mothers will be recruited', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Researchers analyzing the immunological outcomes will be blinded to the groups of the subjects (pregnant vs non pregnant ; infants)', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2023-05-12