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Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
This study has been terminated.
Sponsored by: | National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
Purpose
PRIMARY: To evaluate the short-term safety of rgp120/HIV-1SF2 vaccine versus MF59 placebo administered to HIV-infected pregnant women. SECONDARY: To evaluate the immunogenicity and long-term safety of rgp120/HIV-1SF2 in HIV-infected pregnant women who received the vaccine during pregnancy only or during pregnancy and postpartum. To evaluate immunogenicity and safety in the infant through 18 months of age following maternal immunization with the vaccine during pregnancy. Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibody. Also, active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers.
Condition | Treatment or Intervention | Phase |
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HIV Infections Pregnancy HIV Seronegativity |
Vaccine: MF59 Vaccine: rgp120/HIV-1 SF-2 |
Phase I |
MedlinePlus related topics: AIDS
Study Type: Interventional
Study Design: Prevention, Parallel Assignment, Safety Study
Expected Total Enrollment: 24
Active immunization of HIV-infected women during pregnancy may slow the progression of maternal disease, reduce the titer of virus in maternal plasma, and increase the titer of epitope-specific antibody. Also, active immunization has the potential to induce primary immunity in the fetus and to boost both T-cell and humoral immune responses to HIV in the mothers.
Women are randomized to receive rgp120/HIV-1SF2 vaccine or MF59 placebo. Patients receive the first immunization between 16 and 24 weeks gestation and monthly thereafter until delivery, for a maximum of five immunizations. Patients may continue to receive the immunization regimen to which they were originally assigned at 3, 6, 9, and 12 months postpartum. Maternal follow-up continues until 18 months postpartum; infants are followed until age 18 months.
Eligibility
Ages Eligible for Study: 16 Years - 40 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria
Concurrent Medication: Allowed during pregnancy:
NOTE:
NOTE:
Patients must have:
NOTE:
Prior Medication: Allowed:
Exclusion Criteria
Co-existing Condition: Patients with the following symptoms or conditions are excluded:
Presence of obstetrical high-risk factors such as:
Concurrent Medication: Excluded during pregnancy:
NOTE:
Prior Medication: Excluded within 90 days prior to study entry:
Current use of illicit drugs or chronic alcohol use by patient history.
Location Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
Copyright, Privacy, Accessibility, Freedom of Information Act |