Diphtheria toxoid; Tetanus toxoid; Pertussis toxoid; Pertussis filamentous haemagglutinin; Pertussis pertactin; Pertussis fimbrial agglutinogens (FIM) 2 and 3 for Pregnancy

Inclusion criteria

• {"criterion_text":"-Ability to provide informed consent.\n-Willing to be vaccinated with a Tdap vaccine during pregnancy.\n-Intend to be available for follow-up visits and phone call access until 6 months postpartum.\n-Influenza and COVID-19 vaccination during pregnancy (as per Belgian recommendations) is allowed."}

Exclusion criteria

• {"criterion_text":"-Vaccinated with an aP containing vaccine during the last 5 years.\n-Significant mental illness (e.g. schizophrenia, psychosis, major depression).\n-Serious underlying immunological condition (e.g. immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection…).\n-Systemic treatment with immune suppressive medication, including chronic steroid use of > 10 mg prednisone or equivalent.\n-Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.\n-Previous severe reaction to any vaccine\n-High risk for serious obstetrical complications."}

Primary endpoints

• {"endpoint_text":"-Measurement of antibody levels and functional antibody characteristics in maternal blood with Tdap vaccination at different timings in pregnancy (measurement at baseline, after Tdap vaccination, at delivery and 6 months postpartum).","definition_or_measurement_approach":"Measure antibody levels and functional antibody characteristics in maternal blood at baseline, after Tdap vaccination, at delivery and at 6 months postpartum."}

Secondary endpoints

• {"endpoint_text":"-Measurement of cytokine levels and T-cell subsets in maternal blood after Tdap vaccination at different timings in pregnancy (measurement at baseline, after Tdap vaccination, at delivery and 6 months postpartum).","definition_or_measurement_approach":"Measure cytokine levels and T-cell subsets in maternal blood at baseline, after Tdap vaccination, at delivery and at 6 months postpartum."}
• {"endpoint_text":"-Measurement of antibody levels in cord blood at delivery after Tdap vaccination at different timings in pregnancy to calculate the transport of antibodies across the placenta.","definition_or_measurement_approach":"Measure antibody levels in cord blood at delivery to calculate placental antibody transport."}
• {"endpoint_text":"-Measurement of antibody levels, subclass antibody levels, antibody glycosylation and antibody functionality in breastmilk 6 months postpartum after Tdap vaccination at different timings in pregnancy.","definition_or_measurement_approach":"Measure antibody levels, subclasses, glycosylation and functionality in breastmilk at 6 months postpartum."}

Belgium

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

24-10-2024

Processing Time Days

2

Number Of Sites

1

Number Of Participants

96

Primary sponsor

Full Name

University Of Antwerp

Organisation Type

Educational Institution

Country Of Registered Address

Belgium