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)
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
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.
Trial Health
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 1, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed during pregnancy:
- AZT.
- Methadone maintenance.
- NOTE:
- Patients may not initiate antiretroviral therapy for disease progression.
- NOTE:
- Patients may change from AZT to another antiretroviral agent or may begin antiretroviral therapy following delivery, if clinically indicated.
- Patients must have:
- Documented HIV infection.
- CD4 count \>= 400 cells/mm3 (average of two determinations obtained 1 week apart).
- No clinical criteria for a diagnosis of AIDS.
- HIV p24 antigen \<= 30 pg/ml.
- Estimated gestational age between 16 and 24 weeks, confirmed by baseline sonogram that does not demonstrate any congenital abnormalities considered to be incompatible with life.
- Intention to carry pregnancy to term.
- +6 more criteria
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Known hypersensitivity to a component of the vaccine.
- Hepatitis B antigen positive at study entry.
- Evidence of life-threatening or other serious pre-existing fetal abnormalities (e.g., anencephaly, renal agenesis, Potter's syndrome).
- Evidence of syphilis that requires therapy during this pregnancy.
- Intention to breast-feed.
- Presence of obstetrical high-risk factors such as:
- insulin-dependent diabetes
- hypertension requiring the use of anti-hypertensive therapy
- repeated intrauterine fetal demise
- Rh-sensitization or other blood group alloimmunization
- diseases requiring use of immunosuppressive therapy (e.g., asthma, lupus).
- Concurrent Medication:
- Excluded during pregnancy:
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Starr S
- STUDY CHAIR
Allen M
- STUDY CHAIR
Scott GB
- STUDY CHAIR
Silverman N
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
November 1, 2021
Record last verified: 2021-10