Aim/objective: This study investigates placental antibody transfer following recombinant pertussis vaccination in pregnancy in a real-world setting.
Methods: This postmarketing observational study recruited pregnant women vaccinated with monovalent recombinant acellular pertussis (aP) vaccine (aP; n = 199) or combined to tetanus-diphtheria (TdaP; n = 200), or Td-vaccine only (n = 54). Pregnancy, delivery, and neonatal outcomes were assessed.
Vaccine
January 2024
Introduction: Recombinant acellular pertussis (ap) vaccines containing genetically inactivated pertussis toxin (PT) and filamentous hemagglutinin (FHA) with or without tetanus (TT) and diphtheria (DT) vaccines (Td) were found safe and immunogenic in non-pregnant and pregnant women. We report here maternal antibody transfer and safety data in mothers and neonates.
Methods: This is the follow up of a phase 2 trial in 2019 among 400 pregnant women who randomly received one dose of recombinant pertussis-only vaccine containing 1 µg PT and 1 µg FHA (ap1), or Td combined with ap1 (Tdap1), or with 2 µg PT and 5 µg FHA (Tdap2), or with 5 µg PT and 5 µg FHA (TdaP5 Boostagen®, BioNet, Thailand) or chemically-inactivated acellular pertussis comparator (Tdap8 Boostrix™, GSK, Belgium), either in the second or third trimester of gestation.
Vaccine
July 2023
Introduction: Despite a decrease in infections caused by Bordetella pertussis due to COVID-19 pandemic, booster vaccination of pregnant women is still recommended to protect newborns. Highly immunogenic vaccines containing genetically inactivated pertussis toxin (PT) and filamentous hemagglutinin (FHA) may generate comparable anti-PT antibody concentrations, even at lower doses, to chemically inactivated acellular pertussis vaccines (Tdap) shown effective for maternal immunization.
Methods: This phase 2 randomized, observer-blind, active-controlled non-inferiority trial was conducted in healthy Thai pregnant women randomly assigned to receive one dose of low-dose recombinant pertussis-only vaccine containing 1 µg PT and 1 µg FHA (ap1), or tetanus, reduced-dose diphtheria combined with ap1 (Tdap1), or combined with 2 µg PT and 5 µg FHA (Tdap2), or with 5 µg PT and 5 µg FHA (TdaP5, Boostagen®) or comparator containing 8 µg of chemically inactivated pertussis toxoid, 8 µg FHA, and 2.