NCT00007332

Brief Summary

The purpose of this study is to see if the vaccines tested are safe when given alone and when given together, and how the immune system responds to the vaccines. Vaccines are given to people to try to prevent an infection or disease. Early testing in a few people has shown that the HIV vaccines ALVAC vCP1452 and AIDSVAX B/B seem to be safe to use.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for phase_2 hiv-infections

Geographic Reach
1 country

17 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

December 16, 2000

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
Last Updated

October 15, 2021

Status Verified

October 1, 2021

First QC Date

December 16, 2000

Last Update Submit

October 13, 2021

Conditions

HIV Infections

Keywords

Drug Therapy, CombinationHIV Envelope Protein gp120AIDS VaccinesCD8-Positive T-LymphocytesHIV SeronegativityAIDSVAXHIV Preventive Vaccine

Interventions

ALVAC(2)120(B,MN)GNP (vCP1452)BIOLOGICAL
MN rgp120/HIV-1 and GNE8 rgp120/HIV-1BIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteers may be eligible for this study if they:
  • Are HIV-negative.
  • Are 18 to 60 years old.
  • Have a CD4 cell count of 400 cells/mm3 or more.
  • Agree to use adequate birth control for 1 month before study entry and during the study (female participants).
  • Have a normal history and physical examination.
  • Are available for 12 months of follow-up for the planned duration of the study.
  • Have a negative pregnancy test within 3 days prior to injections.

You may not qualify if:

  • Volunteers will not be eligible for this study if they:
  • Are pregnant or breast-feeding.
  • Have chronic hepatitis B.
  • Are taking medications that affect the immune system.
  • Have an immune system problem, any long-term illness, or any autoimmune disease.
  • Have cancer, except if it has been removed with surgery and cure is likely.
  • Have a physical condition, mental condition, or job or work that may interfere with the study.
  • Have been suicidal, or have ever needed medicines for a serious mental condition.
  • Have received certain vaccines within 60 days of study entry.
  • Have used experimental drugs within 30 days prior to study entry.
  • Have received any blood products, such as immunoglobulin, in the last 6 months.
  • Have active syphilis.
  • Have active tuberculosis.
  • Have history of severe allergy or any serious reactions to vaccines.
  • Have had HIV-1 vaccines in a clinical study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Alabama Vaccine CRS

Birmingham, Alabama, 35294, United States

Location

San Francisco Dept. of Public Health, San Francisco Gen. Hosp.

San Francisco, California, 94102, United States

Location

San Francisco Vaccine and Prevention CRS

San Francisco, California, United States

Location

Project Brave HIV Vaccine CRS

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins Bloomberg School of Public Health, Ctr. for Immunization Research, Project SAVE-DC

Baltimore, Maryland, 21205, United States

Location

Johns Hopkins Bloomberg School of Public Health,Ctr for Immunization Research,Project SAVE-Baltimore

Baltimore, Maryland, United States

Location

Brigham and Women's Hosp. CRS

Boston, Massachusetts, 02115, United States

Location

Fenway Community Health Clinical Research Site (FCHCRS)

Boston, Massachusetts, 02215, United States

Location

Saint Louis Univ. School of Medicine, HVTU

St Louis, Missouri, 63110, United States

Location

HIV Prevention & Treatment CRS

New York, New York, 10032, United States

Location

NY Blood Ctr./Union Square CRS

New York, New York, United States

Location

Univ. of Rochester HVTN CRS

Rochester, New York, 14642, United States

Location

NY Blood Ctr./Bronx CRS

The Bronx, New York, 10456, United States

Location

Miriam Hospital's HVTU

Providence, Rhode Island, 02906, United States

Location

Vanderbilt Vaccine CRS

Nashville, Tennessee, 37232, United States

Location

Infectious Diseases Physicians, Inc.

Annandale, Virginia, 22003, United States

Location

FHCRC/UW Vaccine CRS

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Barney Graham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2000

First Posted

August 31, 2001

Study Completion

April 1, 2003

Last Updated

October 15, 2021

Record last verified: 2021-10

Locations

US(17)