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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate (Biological)
结局指标
主要结局
Geometric Mean Fold Rise in Serum Immunoglobulin G (IgG) by ELISA at Week 2
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
- ELISA GMC of Breast Milk IgA to FHA at Week 2.(2 weeks post vaccination)
- ELISA GMC of Breast Milk IgA to FHA at Week 6.(6 weeks post vaccination)
- ELISA GMC of Breast Milk IgA to FHA at Month 6.(6 months post vaccination)
- ELISA GMC of Breast Milk IgA to PRN and FIM by Study Day.(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.(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(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.(Prior to vaccination, 2 weeks, 6 weeks, and 6 months after vaccination)