NCT00001041

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 hiv-infections

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

July 1, 1998

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

November 2, 1999

Last Update Submit

October 28, 2021

Conditions

HIV InfectionsPregnancy

Keywords

Vaccines, SyntheticPregnancyPregnancy Complications, InfectiousHIV Envelope Protein gp120AIDS VaccinesHIV Therapeutic Vaccine

Interventions

rgp120/HIV-1MNBIOLOGICAL

Eligibility Criteria

Age16 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Concurrent Medication:
  • Allowed:
  • AZT.
  • Acyclovir.
  • Patients must have:
  • HIV-1 infection.
  • CD4 count \>= 400 cells/mm3.
  • No AIDS-defining illness or other systemic manifestations related to HIV (other than generalized lymphadenopathy).
  • HIV p24 \< 30 pg/ml.
  • Proven pregnancy in the 16th to 24th week of gestation at study entry, with no special obstetrical risks.
  • Concurrent AZT therapy is permitted.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following symptoms and conditions are excluded:
  • Known hypersensitivity to a component of the vaccine.
  • Evidence of fetal abnormality on ultrasound.
  • Evidence of maternal risk factors including insulin-dependent diabetes, moderate to severe hypertension, repeated fetal wastage (\> 3), Rh-sensitization or other blood group alloimmunization, severe renal disease, previous infants with malformations or other factors that obstetrically are judged to constitute a special risk of spontaneous abortion or premature birth.
  • Active syphilis.
  • Hepatitis B surface antigen positive.
  • Concurrent Medication:
  • Excluded:
  • Antiretroviral or immunomodulating agent other than AZT during the pregnancy.
  • Prior Medication:
  • Excluded:
  • Antiretroviral or immunomodulating agent other than AZT within 90 days prior to study entry.
  • Current use of illicit drugs or known chronic alcohol use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

San Francisco Gen. Hosp.

San Francisco, California, 941102859, United States

Location

UCSF Pediatric AIDS CRS

San Francisco, California, United States

Location

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases

Baltimore, Maryland, 212874933, United States

Location

Washington U CRS

St Louis, Missouri, 63104, United States

Location

St. Louis ConnectCare, Infectious Diseases Clinic

St Louis, Missouri, 63112, United States

Location

Univ. of Rochester ACTG CRS

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Hompe ED, Mangold JF, Kumar A, Eudailey JA, McGuire E, Haynes BF, Moody MA, Wright PF, Fouda GG, Giorgi EE, Gao F, Permar SR. Induction of Neutralizing Responses against Autologous Virus in Maternal HIV Vaccine Trials. mSphere. 2020 Jun 3;5(3):e00254-20. doi: 10.1128/mSphere.00254-20.

    PMID: 32493720DERIVED

MeSH Terms

Conditions

HIV InfectionsPregnancy Complications, Infectious

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Wara DW

    STUDY CHAIR

  • Lambert JS

    STUDY CHAIR

  • Wright PF

    STUDY CHAIR

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

Study Completion

July 1, 1998

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(6)