DiphtheriaPhase 4NCT01711645
Tdap Vaccine in Post-Partum Women
A Phase 4 study testing Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate in people with Diphtheria and Pertussis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Diphtheria, Pertussis, Tetanus
- What is being tested?
- Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2012to 28 Aug 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- -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).
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, 37232-2573
About this study
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
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.
Read the 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.
- Conditions
- Diphtheria, Pertussis, Tetanus
- Being tested
- Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate
- Keywords
- Acellular, Adacel®, Diptheria toxoids, Pertussis, postpartum, Tdap, Tetanus, women
- Medical subject headings
- Diphtheria, Whooping Cough, Tetanus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphateBiological
55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PT antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10. Results of <10 were reported as half the LLOQ (5).
Measured: Baseline (prior to vaccination)
ELISA GMC of Breast Milk IgA to PT at Week 2
Breast milk was collected from participants at 2 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
Measured: 2 weeks post vaccination
ELISA GMC of Breast Milk IgA to PT at Week 6
Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
Measured: 6 weeks post vaccination
ELISA GMC of Breast Milk IgA to PT at Month 6
Breast milk was collected from participants at 6 weeks after vaccination for assessment of secretory IgA (sIgA) to PT and FHA by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the PT at this timepoint, all participants had a value of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
Measured: 6 months post vaccination
ELISA GMC of Breast Milk IgA to FHA at Baseline.
Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.
Measured: Baseline (prior to vaccination)
ELISA GMC of Breast Milk IgA to FHA at Week 2.
Breast milk was collected from participants at 2 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.
Measured: 2 weeks post vaccination
ELISA GMC of Breast Milk IgA to FHA at Week 6.
Breast milk was collected from participants at 6 weeks post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL. Note that for the FHA at this timepoint, all participants had a concentration of 5, the imputed value for below the LLOQ of the assay (<10), and so the 95% CI is not reported, as there was no measurable variability in the data. The range is reported.
Measured: 6 weeks post vaccination
ELISA GMC of Breast Milk IgA to FHA at Month 6.
Breast milk was collected from participants at 6 months post vaccination for assessment of secretory IgA (sIgA) to the FHA antigen by ELISA. Available data at the timepoint were summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval.
Measured: 6 months post vaccination
ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.
Breast milk (colostrum) was collected from participants at baseline prior to vaccination for assessment of secretory IgA (sIgA) to the PRN and FIM antigen by ELISA. Available data at the timepoint were to be summarized by geometric mean of the concentration as reported in EU/mL along with the 95% confidence interval. The lower limit of quantitation (LLOQ) of the assay was 10 EU/mL.
Measured: Baseline (prior to vaccination), Week 2, Week 6 and Month 6 post vaccination
Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day.
Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The lower limit of quantification (LLOQ) for the assay was 10 EU/mL. A 4-fold rise in concentration from prior to vaccination was defined as a post-vaccination sIgA concentration greater than or equal to 40 EU/mL for participants with baseline sIgA concentrations less than the LLOQ, or 4 times the baseline sIgA concentration for baseline sIgA concentrations greater than the LLOQ.
Measured: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day
Breast milk samples were collected from participants for evaluation of secretory IgA (sIgA) by ELISA. Geometric mean fold rise was defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.
Measured: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml.
Breast milk samples were collected from participants for evaluation of PT and FHA secretory IgA (sIgA) by ELISA. The protocol defined kinetics as assessment at each post-vaccination timepoint of the geometric mean fold rise, defined as the geometric mean of participants' fold rise in post vaccination sIgA relative to the pre-vaccination sIgA.
Measured: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study start26 Oct 2012
- Primary completion28 Aug 2015
- Study completion28 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711645
- Sponsor's protocol ID
- 11-0035
- Other IDs
- HHSN272201300023I
- Status last verified
- 8 Apr 2015
- First submitted
- 18 Oct 2012
- Last updated
- 5 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01711645
- Acronym / sponsor ID
- 11-0035
- Conditions
- Diphtheria, Pertussis, Tetanus
- Keywords
- Acellular, Adacel®, Diptheria toxoids, Pertussis, postpartum, Tdap, Tetanus, women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 26 Oct 2012 (actual)
- Primary completion
- 28 Aug 2015 (actual)
- Study completion
- 28 Aug 2015 (actual)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adacel® Tdap vaccine | Experimental | Biological: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -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).
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate55 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 |
Primary outcome
Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2
Time frame: Prior to and 2 weeks following vaccination
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).
Geometric Mean Fold Rise in Serum IgG by ELISA at Week 6
Time frame: Prior to and 6 weeks following vaccination
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.
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 6
Time frame: Prior to and 6 months following vaccination
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.
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 12
Time frame: Prior to and 12 months following vaccination
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.
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 18
Time frame: Prior to and 18 months following vaccination
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.
Geometric Mean Fold Rise in Serum IgG by ELISA at Month 24
Time frame: Prior to and 24 months following vaccination
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.
ELISA Geometric Mean Concentrations (GMC) of Serum IgG to PT, FHA, PRN and FIM at Baseline
Time frame: Baseline (prior to vaccination)
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.
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 2
Time frame: 2 weeks post vaccination
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.
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Week 6
Time frame: 6 weeks post vaccination
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.
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 6
Time frame: 6 months post vaccination
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.
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 12
Time frame: 12 months post vaccination
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.
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 18
Time frame: 18 months post vaccination
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.
ELISA GMCs of Serum IgG to PT, FHA, PRN and FIM at Month 24
Time frame: 24 months post vaccination
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.
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 2
Time frame: Prior to and 2 weeks after vaccination
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.
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Week 6
Time frame: Prior to and 6 weeks after vaccination
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.
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 6
Time frame: Prior to and 6 months after vaccination
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.
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 12
Time frame: Prior to and 12 months after vaccination
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.
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 18
Time frame: Prior to and 18 months after vaccination
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.
Count of Participants With 4-fold Rise in ELISA Antibody Concentrations at Month 24
Time frame: Prior to and 24 months after vaccination
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.
Kinetics of the ELISA IgG Antibody Rise in Serum
Time frame: Prior to and following Tdap, through 24 months post-vaccination
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.
12 secondary outcomes
ELISA GMC of Breast Milk IgA to Pertussis Toxin (PT) at Baseline.
Time frame: Baseline (prior to vaccination)
ELISA GMC of Breast Milk IgA to PT at Week 2
Time frame: 2 weeks post vaccination
ELISA GMC of Breast Milk IgA to PT at Week 6
Time frame: 6 weeks post vaccination
ELISA GMC of Breast Milk IgA to PT at Month 6
Time frame: 6 months post vaccination
ELISA GMC of Breast Milk IgA to FHA at Baseline.
Time frame: Baseline (prior to vaccination)
ELISA GMC of Breast Milk IgA to FHA at Week 2.
Time frame: 2 weeks post vaccination
ELISA GMC of Breast Milk IgA to FHA at Week 6.
Time frame: 6 weeks post vaccination
ELISA GMC of Breast Milk IgA to FHA at Month 6.
Time frame: 6 months post vaccination
ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.
Time frame: Baseline (prior to vaccination), Week 2, Week 6 and Month 6 post vaccination
Proportion of Participants With 4-fold Rise in Antibody in Breast Milk by Study Day.
Time frame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
Geometric Mean Fold Rise in Antibody Concentrations Assessed by ELISA in Breast Milk by Study Day
Time frame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
Kinetics of the ELISA IgG Antibody Decline in Breast Milk Expressed in EU/ml.
Time frame: Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate in people with Diphtheria and Pertussis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2 (time frame: Prior to and 2 weeks following vaccination). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.