MedTrace Logo

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)

NCT00000777 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-10-28

No results posted yet for this study

Summary

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.

Conditions

  • HIV Infections
  • Pregnancy
  • HIV Seronegativity

Interventions

BIOLOGICAL

gp160 Vaccine (MicroGeneSys)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Sullivan JL

  • Lambert JS

  • Wright PF

Study Design

Purpose
TREATMENT
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Completion
1998-07-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00000777 on ClinicalTrials.gov