NCT00002402

Brief Summary

The purpose of this study is to see if it is safe and effective to give AIDSVAX B/B or AIDSVAX B/E, two potential HIV vaccines, to HIV-negative volunteers.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
1 country

4 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

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

June 24, 2005

Status Verified

August 1, 1998

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV Infections

Keywords

HIV-1Dose-Response Relationship, DrugAcquired Immunodeficiency SyndromeAIDS VaccinesHIV SeronegativityAntigens, ViralAlum Compounds

Interventions

MN rgp120/HIV-1 and GNE8 rgp120/HIV-1BIOLOGICAL
MN rgp120/HIV-1 and A244 rgp120/HIV-1BIOLOGICAL
Aluminum hydroxideBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Patients must: Be HIV-uninfected men and women at low or intermediate risk for HIV-1 infection.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Dr Frank Judson / Director of Public Health Dept

Denver, Colorado, 80204, United States

Location

Johns Hopkins Bloomberg School of Public Health

Washington D.C., District of Columbia, 20037, United States

Location

Fenway Community Health Ctr

Boston, Massachusetts, 02115, United States

Location

Saint Louis Univ Health Sciences Ctr

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • Mayer K, Judson F, Gorse G, Harro C, Peterson M, Zaharias E, Good J, Shibata R, Lee S, Eastman D, Chernow M, Francis D, Berman P. A phase I/II trial to evaluate the safety and immunogenicity of the AIDSVAX B/B vaccine in the United States (final report). 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 178)

    BACKGROUND

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Interventions

Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAluminum CompoundsAnionsIonsElectrolytes

Study Design

Study Type
interventional
Phase
phase 1
Purpose
PREVENTION
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1998-08

Locations

US(4)