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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)

NCT00001046 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2021-11-01

No results posted yet for this study

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.

Conditions

  • HIV Infections
  • Pregnancy
  • HIV Seronegativity

Interventions

BIOLOGICAL

MF59

BIOLOGICAL

rgp120/HIV-1 SF-2

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Starr S

  • Allen M

  • Scott GB

  • Silverman N

Study Design

Purpose
PREVENTION
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001046 on ClinicalTrials.gov