- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000777
Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of VaxSyn Recombinant gp160 (NOTE: Some Patients Receive Placebo)
To evaluate the safety of gp160 vaccine (VaxSyn) in HIV-1 infected pregnant women with CD4 counts >= 400 cells/mm3. To evaluate the immunogenicity of this vaccine in pregnant women and the passive acquisition of vaccine-specific antibody in their infants.
Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus. Slowing the progression of disease, reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Evidence suggests that an advanced stage of disease with high plasma viremia is associated with increased transmission of HIV-1 to the fetus. Slowing the progression of disease, reducing the titer of virus in plasma, and increasing the titer of epitope-specific antibody are potentially attainable goals through active immunization of the mother during pregnancy.
Pregnant women are randomized to receive an initial injection of VaxSyn or alum placebo between week 16 and week 24 of gestation, followed by monthly booster injections concluding at the end of pregnancy, for a total of five injections. Patients may have optional booster immunizations (vaccine or placebo) at 3, 6, 9, and 12 months after delivery. Mothers and infants are followed through 18 months after delivery.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06504
- Yale Univ Med School
-
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt Univ Hosp
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
Concurrent Medication:
Allowed:
- AZT.
- Acyclovir.
Patients must have:
- HIV-1 infection.
- CD4 count >= 400 cells/mm3.
- No AIDS-defining illness or other systemic manifestations related to HIV (other than generalized lymphadenopathy).
- HIV p24 < 30 pg/ml.
- Proven pregnancy in the 16th to 24th week of gestation at study entry, with no special obstetrical risks.
- Concurrent AZT therapy is permitted.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Known hypersensitivity to a component of the vaccine.
- Evidence of fetal abnormality on ultrasound.
- Evidence of maternal risk factors including insulin-dependent diabetes, moderate to severe hypertension, repeated fetal wastage (> 3), Rh-sensitization or other blood group alloimmunization, severe renal disease, previous infants with malformations or other factors that obstetrically are judged to constitute a special risk of spontaneous abortion or premature birth.
- Active syphilis.
- Hepatitis B surface antigen positive.
Concurrent Medication:
Excluded:
- Antiretroviral or immunomodulating agent other than AZT during the pregnancy.
Prior Medication:
Excluded:
- Antiretroviral or immunomodulating agent other than AZT within 90 days prior to study entry.
Current use of illicit drugs or known chronic alcohol use.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Collaborators and Investigators
Investigators
- Study Chair: Sullivan JL
- Study Chair: Lambert JS
- Study Chair: Wright PF
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ACTG 234
- VEU 102
- 11211 (Registry Identifier: DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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