Tdap Vaccine in Post-Partum Women

NCT01711645 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 11-0035HHSN272201300023I
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Diphtheria; Pertussis; Tetanus

Keywords

Acellular; Adacel®; Diptheria toxoids; Pertussis; postpartum; Tdap; Tetanus; women

Outcome Measures

Primary Outcomes (20)

• Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2

  Blood was collected from participants at baseline prior to vaccination and at 2 weeks after vaccination for assessment of IgG by ELISA against the pertussis toxin (PT), filamentous hemaggluttinin (FHA), pertactin (PRN) and fimbrae (FIM) antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% confidence interval (CI).

  Prior to and 2 weeks following vaccination

• Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6

  Blood was collected from participants at baseline prior to vaccination and at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.

  Prior to and 6 weeks following vaccination

• Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6

  Blood was collected from participants at baseline prior to vaccination and at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.

  Prior to and 6 months following vaccination

• Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12

  Blood was collected from participants at baseline prior to vaccination and at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.

  Prior to and 12 months following vaccination

• Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18

  Blood was collected from participants at baseline prior to vaccination and at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.

  Prior to and 18 months following vaccination

• Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24

  Blood was collected from participants at baseline prior to vaccination and at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. The geometric mean of participants' fold rise in antibody concentrations from baseline to post vaccination was calculated, along with the 95% CI.

  Prior to and 24 months following vaccination

• ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline

  Blood was collected from participants at baseline prior to vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. Antibody concentrations were reported as ELISA units per milliliter (EU/mL). A value of 5 EU/mL was imputed for results reported as below the lower limit of quantitation (LLOQ) (\<10 EU/mL). The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.

  Baseline (prior to vaccination)

• ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2

  Blood was collected from participants at 2 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.

  2 weeks post vaccination

• ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6

  Blood was collected from participants at 6 weeks after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.

  6 weeks post vaccination

• ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6

  Blood was collected from participants at 6 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.

  6 months post vaccination

• ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12

  Blood was collected from participants at 12 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.

  12 months post vaccination

• ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18

  Blood was collected from participants at 18 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.

  18 months post vaccination

• ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24

  Blood was collected from participants at 24 months after vaccination for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens. A value of 5 EU/mL was imputed for results reported as below LLOQ. The geometric mean of participants' concentrations at the timepoint was calculated, along with the 95% CI.

  24 months post vaccination

• Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2

  Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 2 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.

  Prior to and 2 weeks after vaccination

• Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6

  Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 weeks after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.

  Prior to and 6 weeks after vaccination

• Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6

  Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 6 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.

  Prior to and 6 months after vaccination

• Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12

  Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 12 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.

  Prior to and 12 months after vaccination

• Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18

  Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 18 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.

  Prior to and 18 months after vaccination

• Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24

  Blood samples were collected from participants for assessment of IgG by ELISA against the PT, FHA, PRN and FIM antigens at baseline prior to vaccination and 24 months after vaccination. A 4-fold rise in antibody concentration from prior to vaccination was defined as a post-vaccination IgG greater than or equal to 40 EU/mL for participants with baseline IgG concentrations less than the LLOQ (10), or 4 times the baseline IgG concentration for baseline IgG concentrations greater than the LLOQ.

  Prior to and 24 months after vaccination

• Kinetics of the ELISA IgG Antibody Rise in Serum

  The assessment of the kinetics of the ELISA IgG antibody rise in serum was defined by the protocol as the geometric mean fold rise at each timepoint (reported separately above). No additional analysis was pre-defined or performed for this outcome measure.

  Prior to and following Tdap, through 24 months post-vaccination

Secondary Outcomes (12)

• ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.

  Baseline (prior to vaccination)

• ELISA GMC of Breast Milk IgA to PT at Week 2

  2 weeks post vaccination

• ELISA GMC of Breast Milk IgA to PT at Week 6

  6 weeks post vaccination

• ELISA GMC of Breast Milk IgA to PT at Month 6

  6 months post vaccination

• ELISA GMC of Breast Milk IgA to FHA at Baseline.

  Baseline (prior to vaccination)

Study Arms (1)

Adacel® Tdap vaccine

EXPERIMENTAL

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: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate

Interventions

Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate BIOLOGICAL

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

Adacel® Tdap vaccine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center

Nashville, Tennessee, 37232-2573, United States

Location

MeSH Terms

Conditions

Diphtheria; Whooping Cough; Tetanus

Interventions

Tetanus Toxoid

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Kathryn M. Edwards, MD
• Organization: Vanderbilt Medical Center

Kathryn.edwards@vanderbilt.edu

615-322-3078

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: October 26, 2012
• Primary Completion: August 28, 2015
• Study Completion: August 28, 2015
• Last Updated: May 5, 2017
• Results First Posted: May 5, 2017

Record last verified: 2015-04-08

Locations

US (1)