Maternal Tdap Immunization in Guatemala (NCT02301702) | Clinical Trial Compass
CompletedPhase 2
Maternal Tdap Immunization in Guatemala
Guatemala286 participantsStarted 2016-07
Plain-language 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.
Who can participate
Age range18 Years – 40 Years
SexALL
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Inclusion criteria
✓. Pregnant woman in late second or third trimester of pregnancy (i.e., after 27 weeks gestation),
✓. Between the ages of 18 and 40 years (inclusive),
✓. Intends to remain in the study area for at least seven months after delivery,
✓. Has access to a mobile phone (defined as a phone in the possession of the participant or another family member with whom she lives),
✓. Able to provide informed consent. If participant is illiterate, procedures to ensure full understanding of the research and consent process will be implemented according to international and federal guidelines.
Exclusion criteria
✕. History of fever or oral temperature ≥ 38.0 degree Celsius within 48 hours prior to vaccination (women can be re-evaluated at a subsequent visit),
Infant pertussis antibody geometric mean concentrations (GMC) and 95% confidence intervals at birth (cord blood OR infant blood within 72 hours of birth), at 2 months of age, and 7 months of age
Timeframe: Birth to 7 months of age
2
Ratio of infant to mother pertussis antibody levels at the time of delivery
Timeframe: Birth to 7 months of age
3
Proportion of infants with at least a four-fold rise in serum antibody titer between 2 months and seven months of age (i.e., at four weeks after the 3rd dose of childhood DTwP)
Timeframe: Birth to 7 months of age
4
Maternal pertussis antibody GMC and 95% confidence intervals at baseline (pre-vaccination), within 72 hours after delivery, and seven months post-partum
Timeframe: Pre-vaccination to 7 months post-partum
5
Proportion of mothers sero-converting (serum pertussis antibody titer increase of ≥ 4-fold compared to pre-vaccination antibody levels) and 95% confidence intervals at the time of delivery (within 72 hours after delivery) and seven months post-partum
Timeframe: Pre-vaccination to 7 months post-partum
✕. High risk pregnancy, as identified by the Normas de Atención en Salud Integral, a guideline document published by the Ministry of Health, and also any previous complicated pregnancy or preterm delivery, spontaneous or medical abortion, or previous congenital anomaly,
✕. Received immunoglobulin or other blood product within the preceding 3 month (with the exception of Rhogam),
✕. History of allergy to any component of the vaccines (i.e. eggs, egg proteins, gelatin, formaldehyde, glutaraldehyde, polyethylene glycol p-isooctylphenyl ether, sucrose, aluminum hydroxide, polysorbate 80) or to latex,
✕. History of severe reaction (including hypersensitivity) after receiving any vaccine,
✕. History or evidence of immunosuppression (due to illness or treatment) or is on immunosuppressive therapy (includes long term use of steroids; use of high-dose inhaled steroids within past six months; with the exception of treatment with betamethasone or dexamethasone injections for the prevention of lung immaturity in the last trimester of pregnancy,