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View Clinical Trial (Medical Research Study)
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Pertussis Vaccine in Healthy Pregnant Women - NCT00707148-98105 (Clinical Trial 229314)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy229314.aspx
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| City: |
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Seattle |
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State:
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WA |
| Zip Code: |
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98105 |
| Conditions: |
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Diphtheria - Pertussis - Tetanus |
| Purpose: |
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The purpose of this study is to look at the safety and immunogenicity of a combination
vaccine that includes tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis
(Tdap). The study will be conducted in 48 pregnant women and 32 non-pregnant women. Safety
of the newborn infant and the effect of the mother's vaccination on the infants' immune
responses prior to vaccinating infants with another combination vaccine to protect against
diphtheria, tetanus, and pertussis will be evaluated. Participants will be 18-45 years old.
Pregnant volunteers will be 30-32 weeks pregnant and at a low risk for pregnancy
complications. Pregnant volunteers will receive 2 injections (1 vaccine and 1 placebo,
inactive substance); non-pregnant volunteers will receive 1 injection of vaccine. Blood
samples will be collected from the mother and infant, along with the baby's growth
measurements. Participation for mother infant pairs is about 15 months and about 7 months
for non-pregnant women.
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| Study summary: |
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Pertussis, "whooping cough", caused by the gram negative pleomorphic bacillus, Bordetella
pertussis, is a highly contagious, potentially life-threatening respiratory illness that has
re-emerged in the United States (US) as a cause of morbidity and mortality in infants less
than 6 months of age as well as morbidity in adolescents and adults. Tetanus toxoid, reduced
diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap) immunization of women in
the third trimester of pregnancy represents an opportunity to protect the vulnerable very
young infants through passively acquired maternal pertussis specific antibodies. Tdap
vaccine is being evaluated for this purpose since there is no monovalent acellular pertussis
(aP) vaccine available in the U.S. This is a multi-site, randomized, double masked,
cross-over study in 48 healthy pregnant women, 18-45 years of age who will be randomized
(2:1) into two groups. One group will receive a single dose of Tdap vaccine at 30-32 weeks
of gestation and a postpartum dose of saline. The other group will receive saline at 30-32
weeks of gestation and a postpartum dose of Tdap vaccine. On May 30, 2008 the Advisory
Committee on Immunization Practices (ACIP) issued a recommendation for use of Tdap in
pregnant and postpartum women: "Pregnant women (including women who are breastfeeding) who
have not received a dose of Tdap previously should receive Tdap after delivery and before
discharge from the hospital or birthing center if 2 years or more have elapsed since the
most recent administration of Td." This study design provides a control for the evaluation
of the safety of Tdap vaccine administered during pregnancy and provides compliance with the
ACIP recommendation. Immune responses to Tdap vaccine measured in antepartum and postpartum
women enrolled in this clinical trial will be compared. Also, immune responses of the 32
pregnant women antenatally immunized with Tdap will be compared to those in approximately 32
healthy non-pregnant women contemporaneously enrolled into 2 age groups (18-39 years and
40-45 years) that are equal to the pregnant women. The purpose of this study is to evaluate
the safety of Tdap vaccine in pregnant women and their neonates and the effect of maternal
immunization on the infant immune response to DTaP vaccinations. The safety of and immune
response to Tdap vaccine in the 32 pregnant women immunized antenatally will be compared to
that in approximately 32 non-pregnant women enrolled contemporaneously. The primary
objectives of this phase I study are: to evaluate the safety of a single 0.5 mL
intramuscular injection of Tdap vaccine in healthy pregnant women vaccinated at 30-32 weeks
of gestation compared to women immunized postpartum and a non-pregnant control group; and to
evaluate the safety of maternal Tdap immunization in neonates. Secondary objectives are: to
assess the immunogenicity of Tdap vaccine in healthy pregnant women compared to women
immunized postpartum and a non-pregnant control group; to determine the efficiency of
placental transport of maternal pertussis specific antibodies to the neonate; to assess the
persistence of the maternal pertussis specific antibodies in infants just prior to receiving
the first dose of DTaP [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed,
Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate] vaccine for
infants); and to assess the effects of maternal immunization with Tdap vaccine on infant
immune responses to DTaP vaccinations. Study duration will be approximately 3 years. Subject
participation will be approximately 15 months (for each mother-infant pair) and 7 months for
non-pregnant women. |
| Criteria: |
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Inclusion Criteria:
Pregnant subjects must meet all inclusion criteria in order to be eligible to participate
in the study.
- 18 - 45 years of age
- In the 30th-32nd week of a pregnancy at low risk for complications as determined by
the Obstetrical Risk Assessment Form [ORAF] and the following criteria:
All Pregnant Women:
- Second trimester or later ultrasound with no significant abnormalities.
- Alpha fetal protein (AFP) testing, one of the following:
1. Normal maternal serum AFP performed at 15-20 weeks' gestation (either as part of
the quad screen or separately)
2. Abnormal maternal serum AFP at 15-20 weeks' gestation followed by an
amniocentesis demonstrating no chromosomal abnormalities AND either normal
amniotic fluid AFP or normal amniotic fluid acetylcholinesterase (AChE) levels.
3. If a serum AFP test is not performed, one of the following:
i. A level II ultrasound with no significant abnormalities ii. A normal amniotic
fluid AFP test AND an amniocentesis demonstrating no chromosomal abnormalities must
be documented.
Pregnant Women 40-45 years of age: no chromosomal abnormalities identified by diagnostic
testing [chorionic villus sampling (CVS) or amniocentesis].
- Pregnant Women 18-39 years of age: at least one of the following:
1. Level II ultrasound with no significant abnormalities
2. No chromosomal abnormalities identified by diagnostic testing (CVS or
amniocentesis)
3. Pregnancy estimated to be at low risk (< 1 in 270) for Down's syndrome (trisomy
21), trisomy 13 and trisomy 18 by appropriate first or second trimester
screening test. Appropriate screening test includes any one of the following:
i. first trimester screening (nuchal translucency measurement, pregnancy-associated
plasma protein A (PAPP-A), and beta- human chorionic gonadotropin (B-hCG) ii. first
trimester screening and second trimester quad screen, with risk estimated using an
integrated, sequential, or contingency approach iii. second trimester quad screen
alone
- Intend to be available for follow-up visits and phone call access through 13 months
following delivery
- Willing to have infant immunized with Pentacel vaccine at 2, 4, 6, and 12 months of
age
- Willing to give written informed consent
Non-pregnant subjects must meet all inclusion criteria in order to be eligible to
participate in the study.
- 18-39 years of age or 40-45 years of age
- Intend to be available for a follow-up visit and phone call access through 6 months
following receipt of Adacel vaccine
- Willing to give written informed consent
- Must fulfill one of the following: (i) she is not able to bear children because she
has been surgically sterilized (tubal ligation, bilateral oophorectomy or
hysterectomy) for at least one year or is at least 1 year post-menopausal or (ii) she
agrees to practice effective methods of contraception including, but not limited to,
abstinence, monogamous relationship with vasectomized partner, barrier methods, birth
control pills, patches or hormonal shots or hormonal implants, NuvaRing and IUDs
(intrauterine devices), during the study period between enrollment and 30 days
following receipt of the vaccine. (If subject is of childbearing potential, the
method of birth control will be documented.)
- For a female subject of childbearing potential, must have a negative pregnancy test
(urine or serum) within 24 hours prior to vaccination
Exclusion Criteria:
Pregnant subjects who meet any exclusion criteria at baseline will be excluded from the
study.
- Serious underlying medical condition (e.g., immunosuppressive disease or therapy,
human immunodeficiency virus (HIV) infection, collagen vascular disease, diabetes
mellitus, chronic hypertension, moderate to severe asthma, lung/heart disease,
liver/kidney disease, chronic or recurrent infections).
- Significant mental illness (e.g. schizophrenia, psychosis, major depression).
- Currently smoking or using illegal substances.
- History of a febrile illness (greater than or equal to 100.4 degrees Fahrenheit or 38
degrees Celsius) within the past 72 hours for antepartum injection or febrile illness
(greater than or equal to 100.4 degrees Fahrenheit or 38 degrees Celsius) within 24
hours for postpartum injection.
- Previous severe reaction to any vaccine.
- Receipt of tetanus-diphtheria toxoid immunization within the past 2 years.
- Receipt of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
absorbed (Tdap) immunization ever.
- Receipt of a vaccine (excluding influenza), blood product (excluding Rhogam) or
experimental medicine within the 4 weeks prior to antepartum injection through 4
weeks following post-partum injection. However, measles-mumps-rubella vaccine is
permitted post-partum.
- Receipt of or plans to receive influenza vaccine within the 2 weeks prior to or
following antepartum injection.
- Deemed high risk for serious obstetrical complication as determined by the
Obstetrical Risk Assessment Form.
- Anything in the opinion of the investigator that would prevent volunteers from
completing the study or put the volunteer at risk.
Non-pregnant subjects who meet any exclusion criteria at baseline will be excluded from
the study.
- Serious underlying medical condition (e.g., immunosuppressive disease or therapy, HIV
infection, collagen vascular disease, diabetes mellitus, chronic hypertension,
moderate to severe asthma, lung/heart disease, liver/kidney disease, chronic or
recurrent infections).
- Significant mental illness (e.g. schizophrenia, psychosis, major depression).
- Currently smoking or using illegal substances.
- History of a febrile illness (greater than or equal to 100.4 degrees Fahrenheit or 38
degrees Celsius) within the past 72 hours.
- Previous severe reaction to any vaccine.
- Receipt of tetanus-diphtheria toxoid immunization within the past 2 years.
- Receipt of Tdap immunization ever.
- Receipt of or plans to receive an investigational or licensed vaccine (excluding
influenza), blood product or experimental medicine within the 4 weeks prior to Adacel
vaccination through 4 weeks following Adacel vaccination
- Receipt of or plans to receive influenza vaccine within the 2 weeks prior to or
following Adacel vaccination.
- Intends to become pregnant during the study period between enrollment and 30 days
following receipt of the vaccine.
- Anything in the opinion of the investigator that would prevent a volunteer from
completing the study or put the volunteer at risk. |
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| Study is available at: |
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Seattle Children's Hospital
Seattle, WA 98105
United States
Primary Contact:
Carol Baker
Phone: (719) 798-4790 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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