Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)

Phase 1

Completed

• Conditions: HIV Infections; Pregnancy

• Registration Number: NCT00001041
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

To evaluate the safety of rgp120/HIV-1MN vaccine 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. To evaluate the induction or augmentation by rgp120/HIV-1MN vaccine of mucosal immune response in the gastrointestinal and reproductive tracts during pregnancy. To isolate and genetically characterize the HIV-1 present in cervicovaginal fluid specimens of pregnant women and compare it to that present in their peripheral blood mononuclear cells and to that of their infected 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.

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 MN rgp120 vaccine 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. Per 06/94 addendum, patients will be contacted once or twice per year for at least 5 years to check on health status of patient and child. PER 12/21/94 ADDENDUM, post-partum immunizations are discontinued.

Study Timeline

• Study Completion: 1998-07
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (6)

San Francisco Gen. Hosp.; 🇺🇸 San Francisco, California, United States

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases; 🇺🇸 Baltimore, Maryland, United States

UCSF Pediatric AIDS CRS; 🇺🇸 San Francisco, California, United States

Washington U CRS; 🇺🇸 Saint Louis, Missouri, United States

Univ. of Rochester ACTG CRS; 🇺🇸 Rochester, New York, United States

St. Louis ConnectCare, Infectious Diseases Clinic; 🇺🇸 Saint Louis, Missouri, United States