A Study to Test the Safety of Three Experimental HIV Vaccines

NCT00000946 | Completed Phase 1

• 2 other identifiers: AVEG 03210581
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to test three experimental HIV vaccines. This study will look at whether it is safe to give these vaccines together and how the immune system responds to the vaccines. There are a number of studies being performed to test HIV vaccines. The vaccines that seem to be the most promising are canarypox vaccines, known as ALVAC vaccines. The three experimental HIV vaccines used in this study are called ALVAC-HIV vCP205, HIV-1 SF-2 p24, and HIV-1 SF-2 rgp120. The HIV-1 SF-2 p24 and HIV-1 SF-2 rgp120 vaccines are mixed with an adjuvant, which is a substance that increases immune response.

Conditions

HIV Infections; HIV Seronegativity

Keywords

Drug Evaluation; Drug Therapy, Combination; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Interventions

HIV p24/MF59 Vaccine BIOLOGICAL

ALVAC-HIV MN120TMG (vCP205) BIOLOGICAL

ALVAC-RG Rabies Glycoprotein (vCP65) BIOLOGICAL

rgp120/HIV-1 SF-2 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• You may be eligible for this study if you:
• Are between the ages of 18 and 60.
• Are HIV-negative.
• Are negative for Hepatitis B.
• Have a normal physical exam.
• Are available for 18 months of follow-up.
• Agree to use an effective method of birth control for 1 month before receiving a vaccine and during the study.

You may not qualify if:

• You will not be eligible for this study if you:
• Have a history of an immunodeficiency, chronic illness, or cancer.
• Have a medical or psychiatric condition which would make you unable to comply with the study.
• Are at higher-risk for HIV infection; for example, have a history of injection drug use in the past year or practice higher risk sexual behavior.
• Have syphilis or tuberculosis.
• Have received a live vaccine in the past 60 days, have ever received an HIV vaccine or placebo in a previous HIV vaccine study, or have ever received a rabies vaccine.
• Have a history of a serious allergic reaction to a vaccine or to any other substance, including neomycin or egg products.
• Have received certain medications.
• Are pregnant or breast-feeding.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (7)

UAB AVEG

Birmingham, Alabama, 35294, United States

Location

JHU AVEG

Baltimore, Maryland, 21205, United States

Location

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, 63110, United States

Location

Univ. of Rochester AVEG

Rochester, New York, 14642, United States

Location

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, 37232, United States

Location

FHCRC/UW Vaccine CRS

Seattle, Washington, 98104, United States

Location

UW - Seattle AVEG

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mark J Mulligan, MD

  Univ of Alabama at Birmingham

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: March 1, 2001
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

US (7)