Vaccination against whooping cough in non-pregnant women and in pregnant women. Vaccination against whooping cough in the Belgian vaccination program in children from 2 months of age
Conditions
Interventions
Trade Name: TRIAXIS ®
Product Name: Triaxis®
Product Code: J07AJ52
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: PURIFIED DIPHTHERIA TOXOID
Current Sponsor
Sponsors
Université Libre de Bruxelles
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Eligibility of pregnant and non-pregnant women - Age between 18 and 45 years - Eligible for Tdap vaccination - Last Pertussis vaccination =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Exclusion criteria (non-pregnant women and 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 HBV, HCV or HIV infection, acute toxoplasmosis - Current or recent use of immunosuppressive drugs - Active neoplasia - Other vaccination at the same time as pertussis vaccination Specific to pregnant women: - Risk of premature delivery or intrauterine growth retardation - Twin or triplet pregnancies 2. Exclusion criteria (infants): - Severe neonatal distress - Serious congenital abnormalities or congenital infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 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 immunised compared to infants born to mothers not immunized during pregnancy and identify immune predictors of vaccine responses in the first months of life. ;Primary end point(s): Magnitude and quality of the adaptive immune responses to Tdap immunization. The magnitude and quality of antibody responses to pertussis vaccine will be analysed using an innovative approach pioneered by Galit Alter and Margaret Ackerman, partners on the project, named systems serology including: - Biophysical antibody profiling - Functional antibody profiling - Antibody and B cell repertoire analysis - T lymphocyte response to Tdap immunization Determinants of antibody responses to pertussis immunization: Identification of determinants of vaccine responses in pregnant women and infants will be based on a systems biology approach involving the analysis of peripheral blood cell frequencies, phenotype and transcriptome and of plasma proteome;Timepoint(s) of evaluation of this end point: In non-pregnant women: - The day of vaccination - Day 1 after vaccination - Day 7 after vaccination - Day 28 after vaccination - 5 months after vaccination In pregnant women: - The day of vaccination - Day 1 after vaccination - Day 7 after vaccination - Day 28 after vaccination - At delivery - 6 weeks and 12 weeks after delivery In newborns: - cord blood In infants: - The day of first vaccination (2 months) - Day 1 after the first vaccine dose - the day of the third vaccination and Day 28 aft | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Belgium
Contacts
Public ContactDr Tessa Goetghebuer
CHU Saint Pierre
Outcome results
None listed