Tdap Vaccine in Post-Partum Women

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01711645
• Other study ID #: 11-0035
• Secondary ID: HHSN272200800007
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 18, 2012
• Last updated: September 17, 2015
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: April 2015
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus

Intervention

Biological:
• Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate
55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).

Locations

Country	Name	City	State
United States	Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with 4-fold rise in ELISA antibody concentrations		Prior to and following Tdap, through 24 months post-vaccination	No
Primary	ELISA Geometric mean fold rise by study day		Prior to and following Tdap, through 24 months post-vaccination	No
Primary	ELISA Geometric mean titers (GMT) of serum IgG to pertussis toxin, filamentous hemaglutinin, pertactin and fimbrae measured and assessed in EU/ml		Prior to and following Tdap through 24 months post-vaccination	No
Primary	Kinetics of the ELISA IgG antibody rise in serum expressed in EU/ml.		Prior to and following Tdap, through 24 months post-vaccination	No
Secondary	ELISA GMT of breast milk IgA to pertussis toxin, filamentous hemagluttin, pertactin and fimbrae by study day.		Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination	No
Secondary	ELISA Geometric mean fold rise by study day		Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination	No
Secondary	Kinetics of the ELISA IgG antibody decline in breast milk expressed in EU/ml.		After Tdap and at 2 weeks, 6 weeks, and 6 months after vaccination	No
Secondary	Proportion of subjects with 4-fold rise in antibody concentrations by study day.		Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination	No