Maternal Tdap Immunization in Guatemala
Condition: Pertussis; Whooping Cough
MeSH terms: Whooping Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      Maternal immunization with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis
      vaccine (Tdap) is a potential strategy to protect young infants against pertussis before they
      are fully vaccinated because maternal antibodies may cross the placenta and passively protect
      her infant. The proposed study is a randomized, blinded, controlled, vaccine trial of
      maternal Tdap vaccination during the third trimester of pregnancy (Tdap vaccination at 27-36
      weeks gestation). Pregnant women will be recruited from the prenatal care clinics at the
      Hospital Nacional Occidente and the Health Centers in Quetzaltenango, La Esperanza, San Juan
      Ostuncalco and Concepción Chiquirichapa. Enrolled women and their infants will be followed up
      until 7 months post-partum.
    

Detailed description: 
      The proposed study is a randomized, blinded, controlled, vaccine trial of maternal Tdap
      vaccination during the third trimester of pregnancy (Tdap vaccination at 27-36 weeks
      gestation). Pregnant women will be recruited from the prenatal care clinics at the Hospital
      Nacional de Occidente and the Health Centers in Quetzaltenango, La Esperanza, San Juan
      Ostuncalco and Concepción Chiquirichapa.

      All healthy pregnant women between the ages of 18 and 40 years (inclusive) at 27 weeks
      gestation or later who are in the study areas will be eligible to participate in this study
      unless they meet one or more of the exclusion criteria. Pregnant women at <27 weeks gestation
      will be pre-screened and provided information about the study to encourage them to enroll
      later in their pregnancy. Women who are eligible will be enrolled after obtaining informed
      consent, and then they will be randomized to receive Tdap vaccine or Td vaccine. Enrolled
      women and their infants will be followed up until 7 months postpartum.

      To address the primary objective, serum specimens will be collected from mothers prior to
      receiving the study product (Tdap or Td), within 72 hours after delivery and at 7 months
      post-partum. Moreover, infants specimens will be collected at delivery (cord blood or infant
      blood within 72 hours of birth), at 2 months of age (prior to the first dose of the routine
      childhood DTwP series), and at 7 months of age (approximately 4 weeks after the third dose of
      the routine DTwP series).

      Infants will be given all three doses of the pentavalent vaccine which includes DTwP vaccine
      at 2, 4 and 6 months (routine childhood immunizations) as recommended by the immunization
      schedule of Guatemala's National Immunization Program.

      Adverse events and serious adverse events will also be monitored.
    

Intervention name(s): Tdap; Td
Intervention type(s): Biological; Biological
Intervention description(s): Commercially available, U.S. and Guatemala licensed, 0.5mL intramuscular injection combination tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine; The tetanus toxoid and reduced diphtheria toxoid vaccine (Td) used for this study will be the same preparation used by the National Immunization Program of Guatemala
Other intervention name(s): Boostrix, Adacel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Maternal Immunization; Tdap; Td; Pertussis