A Phase 2 interventional study of Tdap and Td in Pertussis and Whooping Cough, sponsored by Emory University. Completed at 1 site in Guatemala. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-16.
Sponsored by Emory University · Phase 2, Interventional, and Prevention
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.
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.
238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.
This study's enrollment of 286 is below the median of 375 across 180 interventional studies indexed under Whooping Cough.
Browse Whooping Cough studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Combination Tetnus Toxoid, Reduced Diptheria Toxoid and Acellular Pertusis (Tdap)
Biological: Tdap
Tetanus toxoid and reduced diphtheria toxoid vaccine (Td)
Biological: Td
Commercially available, U.S. and Guatemala licensed, 0.5mL intramuscular injection combination tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
Also known as: Boostrix, Adacel
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
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
Time frame: Birth to 7 months of age
Ratio of infant to mother pertussis antibody levels at the time of delivery
Time frame: Birth to 7 months of age
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)
Time frame: Birth to 7 months of age
Maternal pertussis antibody GMC and 95% confidence intervals at baseline (pre-vaccination), within 72 hours after delivery, and seven months post-partum
Time frame: Pre-vaccination to 7 months post-partum
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
Time frame: Pre-vaccination to 7 months post-partum
Incidence of illnesses meeting the syndromic case definition (defined below); prematurity; pneumonia (per WHO Integrated Management of Childhood Illness [IMCI] classification)
Time frame: Birth to 7 months of age
Birth weight and infant growth/anthropometric measurements (e.g., height and weight for age).
Time frame: Birth to 7 months of age
Incidence of unsolicited non-serious (grades 1 & 2) adverse events 7 days post-delivery (for neonates)
Time frame: Birth to 7 months of age
Infant growth/anthropometric measurements (e.g., height and weight z-scores at birth and 7 months of age)
Time frame: Birth to 7 months of age
Incidence of serious (grades 3 & 4) adverse events through 7 months of age
Time frame: Birth to 7 months of age
Laboratory (real-time PCR) confirmed pertussis infection in infants younger than 6 months of age
Time frame: Birth to 7 months of age
Incidence of unsolicited non-serious (grades 1&2) AEs 28 days post vaccination
Time frame: Pre-vaccination to 7 months post-partum
Incidence of serious (grades 3 & 4) adverse events through 7 months post-partum
Time frame: Pre-vaccination to 7 months post-partum
Infant pertussis antibody geometric mean concentrations (GMC) and 95% confidence intervals at 19 months after delivery
Time frame: Pre-vaccination to 19 mo post-partum
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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