Clinical trial NCT01711645: Tdap Vaccine in Post-Partum Women
Official title: Phase IV, Open Label Trial to Evaluate Immunogenicity of Tdap Vaccine in Post-Partum Women to Optimize Vaccination Schedule for Women Who May Have a Subsequent Child
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diphtheria
Pertussis
Tetanus
Keywords: Acellular
Adacel®
Diptheria toxoids
Pertussis
postpartum
Tdap
Tetanus
women
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
First posted: 2012-10-22
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Monitoring immune response and longevity in serum and milk after Tdap administration to postpartum women. The clinical trial will involve women (aged 18 - 45 years) who have just delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at Vanderbilt University Medical Center. The enrollment period will be fifteen months. The duration is over two years of observation.

Detailed description: This is a single site, prospective study involving only one intervention, receipt of a single 0.5 mL intramuscular (IM) dose of Adacel (Tetanus toxoid, reduced diphtheria toxoid and acellular Pertussis) vaccine, among 55 healthy post partum women. The purpose of the study is to examine the immune responses and subsequent decline in serum and breast milk antibody titers over two years of observation. The clinical trial will involve women (aged 18 - 45 years) who have just delivered full-term infants (greater than or equal to 37 completed weeks of gestation) at Vanderbilt University Medical Center. One particular population at Vanderbilt to target will be the "centering prenatal care group" that has breastfeeding rates as high as 75 percent at hospital discharge and maintained at 20 percent at 6 months. The enrollment period will be fifteen months. The subjects, staff assessing subjects, and laboratory personnel will be aware of receipt of the vaccine. Since only a single vaccine product is being utilized, there is no blinding needed of the subjects or staff.

Eligibility criteria: Inclusion Criteria:

-Healthy, postpartum women as determined by medical history aged 18 - 45 years of age inclusive. -Women 1-4 days postpartum from delivery of full-term infants. Full-term will be defined as estimated gestational age of greater than or equal to 37 completed weeks of pregnancy determined by menstrual dating and concordant with ultrasound findings as per ACOG bulletin #101). -Provide written informed consent prior to initiation of any study procedures. -Available for the entire study period. -Able to understand and complete all relevant study procedures during study participation (women who ultimately have limited ability to breast feed after enrollment will not be excluded from the study).

Exclusion Criteria:

-Prior receipt of a tetanus or diphtheria-containing vaccine within two years of enrollment. -Prior receipt of a tetanus and diphtheria toxoid and acellular pertussis vaccine within two years of enrollment. -Known or suspected impairment of immunologic function. -Febrile illness within the last 24 hours or an oral temperature \>/= 100.4 degrees F (\>/= 38 degrees C) at the time of enrollment. -History of documented tetanus, diphtheria, or pertussis disease within the preceding 5 years. -History of allergic or adverse reaction to diphtheria, tetanus, or pertussis vaccines. -Receipt of any steroids, immunoglobulins, other blood products/transfusion within the past six months- excluding Rh immunoglobulin (Rhogam™ and Rhophylac™). -Is enrolled or plans to enroll in another clinical trial with an investigational product while participating in this study (observational studies are allowed). -Known active infection with HIV, hepatitis B, or hepatitis C. -History of alcohol or drug abuse in the last 5 years. -Any condition which, in the opinion of the investigators, may pose a health risk to the subject or interfere with the evaluation of the study objectives. -Any woman with health condition who is currently taking glucocorticoids, i.e., oral, parenteral, and high-dose inhaled steroids, and immunosuppressive or cytotoxic drugs. -Sensitive to latex, based on package insert -Progressive or unstable neurologic condition, based on package insert. -Receipt of influenza or other vaccines concomitantly administered or for 42 days following Adacel, based on package insert.

Primary outcomes:
measure: Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2
timeFrame: Prior to and 2 weeks following vaccination
measure: Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6
timeFrame: Prior to and 6 weeks following vaccination
measure: Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6
timeFrame: Prior to and 6 months following vaccination
measure: Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12
timeFrame: Prior to and 12 months following vaccination
measure: Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18
timeFrame: Prior to and 18 months following vaccination
measure: Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24
timeFrame: Prior to and 24 months following vaccination
measure: ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline
timeFrame: Baseline (prior to vaccination)
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2
timeFrame: 2 weeks post vaccination
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6
timeFrame: 6 weeks post vaccination
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6
timeFrame: 6 months post vaccination
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12
timeFrame: 12 months post vaccination
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18
timeFrame: 18 months post vaccination
measure: ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24
timeFrame: 24 months post vaccination
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2
timeFrame: Prior to and 2 weeks after vaccination
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6
timeFrame: Prior to and 6 weeks after vaccination
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6
timeFrame: Prior to and 6 months after vaccination
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12
timeFrame: Prior to and 12 months after vaccination
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18
timeFrame: Prior to and 18 months after vaccination
measure: Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24
timeFrame: Prior to and 24 months after vaccination
measure: Kinetics of the ELISA IgG Antibody Rise in Serum
timeFrame: Prior to and following Tdap, through 24 months post-vaccination
Secondary outcomes:
measure: ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.
timeFrame: Baseline (prior to vaccination)
measure: ELISA GMC of Breast Milk IgA to PT at Week 2
timeFrame: 2 weeks post vaccination
measure: ELISA GMC of Breast Milk IgA to PT at Week 6
timeFrame: 6 weeks post vaccination
measure: ELISA GMC of Breast Milk IgA to PT at Month 6
timeFrame: 6 months post vaccination
measure: ELISA GMC of Breast Milk IgA to FHA at Baseline.
timeFrame: Baseline (prior to vaccination)
measure: ELISA GMC of Breast Milk IgA to FHA at Week 2.
timeFrame: 2 weeks post vaccination
measure: ELISA GMC of Breast Milk IgA to FHA at Week 6.
timeFrame: 6 weeks post vaccination
measure: ELISA GMC of Breast Milk IgA to FHA at Month 6.
timeFrame: 6 months post vaccination
measure: ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.
timeFrame: Baseline (prior to vaccination), Week 2, Week 6 and Month 6 post vaccination
measure: Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day.
timeFrame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
measure: Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day
timeFrame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
measure: Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml.
timeFrame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
state: Tennessee
Study officials:
References: