Tdap Vaccine in Post-Partum Women

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01711645
First received: October 18, 2012
Last updated: July 24, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Tetanus
Diphtheria
Pertussis
Biological: Adacel® Tdap vaccine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • ELISA Geometric mean fold rise by study day [ Time Frame: Prior to and following Tdap, through 24 months post-vaccination ] [ Designated as safety issue: No ]
  • ELISA Geometric mean titers (GMT) of serum IgG to pertussis toxin, filamentous hemaglutinin, pertactin and fimbrae measured and assessed in EU/ml [ Time Frame: Prior to and following Tdap through 24 months post-vaccination ] [ Designated as safety issue: No ]
  • Kinetics of the ELISA IgG antibody rise in serum expressed in EU/ml. [ Time Frame: Prior to and following Tdap, through 24 months post-vaccination ] [ Designated as safety issue: No ]
  • Proportion of subjects with 4-fold rise in ELISA antibody concentrations [ Time Frame: Prior to and following Tdap, through 24 months post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with 4-fold rise in antibody concentrations by study day. [ Time Frame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination ] [ Designated as safety issue: No ]
  • ELISA Geometric mean fold rise by study day [ Time Frame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination ] [ Designated as safety issue: No ]
  • ELISA GMT of breast milk IgA to pertussis toxin, filamentous hemagluttin, pertactin and fimbrae by study day. [ Time Frame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination ] [ Designated as safety issue: No ]
  • Kinetics of the ELISA IgG antibody decline in breast milk expressed in EU/ml. [ Time Frame: After Tdap and at 2 weeks, 6 weeks, and 6 months after vaccination ] [ Designated as safety issue: No ]

Enrollment: 55
Study Start Date: October 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adacel® Tdap vaccine
55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).
Biological: Adacel® Tdap vaccine
55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01711645

Locations
United States, Tennessee
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, United States, 37232-2573
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01711645     History of Changes
Other Study ID Numbers: 11-0035, HHSN272200800007C
Study First Received: October 18, 2012
Last Updated: July 24, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Tetanus, Diptheria toxoids, Acellular, Pertussis, Tdap, Adacel®, postpartum, women

Additional relevant MeSH terms:
Diphtheria
Whooping Cough
Tetanus
Tetany
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bordetella Infections
Gram-Negative Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Clostridium Infections
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Hypocalcemia
Calcium Metabolism Disorders
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014