Pertussis Vaccine in Healthy Pregnant Women
Safety and Immunogenicity of Tdap Vaccine in Healthy Pregnant Women, Safety in Their Neonates, and Effect of Maternal Immunization on Infant Immune Responses to DTaP Vaccine
3 other identifiers
interventional
80
1 country
4
Brief Summary
The purpose of this study is to look at the safety and immunogenicity of a combination vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety of the newborn infant and the effect of the mother's vaccination on the infants' immune responses prior to vaccinating infants with another combination vaccine to protect against diphtheria, tetanus, and pertussis will be evaluated. Participants will be 18-45 years old. Pregnant volunteers will be 30-32 weeks pregnant and at a low risk for pregnancy complications. Pregnant volunteers will receive 2 injections (1 vaccine and 1 placebo, inactive substance); non-pregnant volunteers will receive 1 injection of vaccine. Blood samples will be collected from the mother and infant, along with the baby's growth measurements. Participation for mother infant pairs is about 15 months and about 7 months for non-pregnant women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2009
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2008
CompletedFirst Posted
Study publicly available on registry
June 30, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJuly 25, 2014
August 1, 2012
3.3 years
June 26, 2008
July 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Incidence of injection site and systemic reactions following injections.
Recorded 0 to 7 days after injection.
Frequency of vaccine-associated adverse events (AEs).
30 minutes post-injection, Day 0, 1-2, 7, 4 weeks post-injection, delivery, Day 1-2, 7, and 2 and 4 months post-delivery. Infant AEs: Delivery, 2, 4, 7, and 13 months. Non-pregnant: Day 0, 1-2, 7, 4 weeks and 6 months.
Frequency of vaccine-associated serious adverse events (SAEs).
Maternal SAEs through 4 months post delivery and infant SAEs from delivery to 13 months. Non-pregnant SAEs: Day 0 through to 6 months post-injection.
Infant growth measurements (fronto-occipital circumference [FOC], length and weight).
At delivery and at 2, 7 and 13 months of age.
Bayley III developmental screening of infants.
At age 13 months.
Incidence of pertussis infection captured by surveillance for adverse events (AEs) and serious adverse events (SAEs).
Duration of study, captured by surveillance for AEs and SAEs. Antepartum: Day 1-2 and 7; 4 weeks; delivery. Postpartum: Day 1-2 and 7; Month 2, 4,7, and 13.
Secondary Outcomes (1)
Concentrations of immunoglobulin G (IgG) for pertussis toxin (PT), pertactin (PRN), fimbrial proteins (FIM), filamentous hemagglutinin (FHA), tetanus toxoid (TT), and diphtheria toxoid (DT).
Mother: blood samples collected before and 4 weeks after antepartum injection, at hospital admission for delivery and at the 2 month post delivery visit. Infant: collected at delivery (cord), 2, 7 and 13 months of age.
Study Arms (3)
Group 2: Control
ACTIVE COMPARATOR16 pregnant women to receive: antepartum: saline; postpartum; Tdap vaccine.
Group 1: Intervention
EXPERIMENTAL32 pregnant women to receive: antepartum: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) vaccine; postpartum: saline.
Group 3: Control
ACTIVE COMPARATOR32 non-pregnant women to receive a single dose of Tdap vaccine.
Interventions
Saline (0.9% NaCl) administered as a single 0.5 mL intramuscular injection into the deltoid.
Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap). Administered as a single 0.5 mL intramuscular injection into the deltoid.
Eligibility Criteria
You may qualify if:
- years of age
- In the 30th-32nd week of a pregnancy at low risk for complications as determined by the Obstetrical Risk Assessment Form \[ORAF\] and the following criteria:
- All Pregnant Women:
- Second trimester or later ultrasound with no significant abnormalities.
- Alpha fetal protein (AFP) testing, one of the following:
- Normal maternal serum AFP performed at 15-20 weeks' gestation (either as part of the quad screen or separately)
- Abnormal maternal serum AFP at 15-20 weeks' gestation followed by an amniocentesis demonstrating no chromosomal abnormalities AND either normal amniotic fluid AFP or normal amniotic fluid acetylcholinesterase (AChE) levels.
- If a serum AFP test is not performed, one of the following:
- i. A level II ultrasound with no significant abnormalities ii. A normal amniotic fluid AFP test AND an amniocentesis demonstrating no chromosomal abnormalities must be documented.
- Pregnant Women 40-45 years of age: no chromosomal abnormalities identified by diagnostic testing \[chorionic villus sampling (CVS) or amniocentesis\].
- Pregnant Women 18-39 years of age: at least one of the following:
- Level II ultrasound with no significant abnormalities
- No chromosomal abnormalities identified by diagnostic testing (CVS or amniocentesis)
- Pregnancy estimated to be at low risk (\< 1 in 270) for Down's syndrome (trisomy 21), trisomy 13 and trisomy 18 by appropriate first or second trimester screening test. Appropriate screening test includes any one of the following:
- i. first trimester screening (nuchal translucency measurement, pregnancy-associated plasma protein A (PAPP-A), and beta- human chorionic gonadotropin (B-hCG) ii. first trimester screening and second trimester quad screen, with risk estimated using an integrated, sequential, or contingency approach iii. second trimester quad screen alone
- +8 more criteria
You may not qualify if:
- Serious underlying medical condition (e.g., immunosuppressive disease or therapy, human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
- Significant mental illness (e.g. schizophrenia, psychosis, major depression).
- Currently smoking or using illegal substances.
- History of a febrile illness (greater than or equal to 100.4 degrees Fahrenheit or 38 degrees Celsius) within the past 72 hours for antepartum injection or febrile illness (greater than or equal to 100.4 degrees Fahrenheit or 38 degrees Celsius) within 24 hours for postpartum injection.
- Previous severe reaction to any vaccine.
- Receipt of tetanus-diphtheria toxoid immunization within the past 2 years.
- Receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine absorbed (Tdap) immunization ever.
- Receipt of a vaccine (excluding influenza), blood product (excluding Rhogam) or experimental medicine within the 4 weeks prior to antepartum injection through 4 weeks following post-partum injection. However, measles-mumps-rubella vaccine is permitted post-partum.
- Receipt of or plans to receive influenza vaccine within the 2 weeks prior to or following antepartum injection.
- Deemed high risk for serious obstetrical complication as determined by the Obstetrical Risk Assessment Form.
- Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
- Serious underlying medical condition (e.g., immunosuppressive disease or therapy, HIV infection, collagen vascular disease, diabetes mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or recurrent infections).
- Significant mental illness (e.g. schizophrenia, psychosis, major depression).
- Currently smoking or using illegal substances.
- History of a febrile illness (greater than or equal to 100.4 degrees Fahrenheit or 38 degrees Celsius) within the past 24 hours.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Duke University Medical Center - Duke Perinatal Clinic
Durham, North Carolina, 27705, United States
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030-3411, United States
Group Health Research Institute - Seattle
Seattle, Washington, 98101-1466, United States
Seattle Children's Hospital - Infectious Diseases
Seattle, Washington, 98105-3901, United States
Related Publications (1)
Munoz FM, Bond NH, Maccato M, Pinell P, Hammill HA, Swamy GK, Walter EB, Jackson LA, Englund JA, Edwards MS, Healy CM, Petrie CR, Ferreira J, Goll JB, Baker CJ. Safety and immunogenicity of tetanus diphtheria and acellular pertussis (Tdap) immunization during pregnancy in mothers and infants: a randomized clinical trial. JAMA. 2014 May 7;311(17):1760-9. doi: 10.1001/jama.2014.3633.
PMID: 24794369RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2008
First Posted
June 30, 2008
Study Start
January 1, 2009
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
July 25, 2014
Record last verified: 2012-08