A Study to Test the Safety of Three Experimental HIV Vaccines

NCT ID: NCT00000946

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2001-03-31

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.

Detailed Description

There are currently several Phase I and II clinical trials being performed within AVEG to evaluate different HIV-1 vaccine candidates. The HIV-1 vaccination approach that is furthest along the clinical development pathway is the so-called prime-boost regimen of live recombinant canarypox priming (ALVAC-HIV vCP205) with recombinant subunit protein boosting (HIV-1 SF-2 rgp120 in MF59 adjuvant). The protein boost enhances neutralizing antibody responses against laboratory strains of HIV-1 in assays performed in vitro, as well as enhancing CD4 cell response and increasing the frequency of CD8 cytotoxic T lymphocytes (CTLs). In all of the ALVAC-HIV trials of the prime-boost regimen completed to date, the protein boost has been the HIV-1 SF-2 rgp120 subunit protein. This study is designed to explore whether boosting of live recombinant canarypox vaccination with a novel protein subunit, recombinant HIV-1 SF-2 p24, can enhance the CD4 and CD8 cell responses directed against HIV-1 antigens.

Volunteers are randomized to 1 of 5 groups. All volunteers receive a total of 4 immunizations, administered at Months 0, 1, 3, and 6. Each group receives a different combination of vaccines as follows:

Group 1: ALVAC-HIV vCP205 plus HIV-1 SF-2 p24. Group 2: ALVAC-HIV vCP205 plus MF59 adjuvant and citrate vehicle (control for HIV-1 SF-2 p24 and HIV-1 SF-2 rgp120) at Months 0 and 1; then ALVAC-HIV vCP205 plus HIV-1 SF-2 p24 at months 3 and 6.

Group 3: ALVAC-HIV vCP205 plus control at Months 0 and 1; then ALVAC-HIV vCP205 plus HIV-1 SF-2 p24 combined with HIV-1 SF-2 rgp120 at Months 3 and 6.

Group 4: ALVAC-HIV vCP205 plus control at Months 0 and 1; then ALVAC-HIV vCP205 plus HIV-1 SF-2 rgp 120 at Months 3 and 6.

Group 5: ALVAC-RG vCP65 (control for ALVAC-HIV vCP205) plus control at Months 0,1,3, and 6.

The study lasts for approximately 18 months; patients receive clinical evaluations to measure vaccine safety at 11 study visits at specified time intervals.

Conditions

HIV Infections; HIV Seronegativity

Keywords

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

Study Design

• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

HIV p24/MF59 Vaccine

Intervention Type: BIOLOGICAL

ALVAC-HIV MN120TMG (vCP205)

Intervention Type: BIOLOGICAL

ALVAC-RG Rabies Glycoprotein (vCP65)

Intervention Type: BIOLOGICAL

rgp120/HIV-1 SF-2

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark J Mulligan, MD

Role: STUDY_CHAIR

Univ of Alabama at Birmingham

Locations

UAB AVEG

Birmingham, Alabama, United States

JHU AVEG

Baltimore, Maryland, United States

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, United States

Univ. of Rochester AVEG

Rochester, New York, United States

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, United States

FHCRC/UW Vaccine CRS

Seattle, Washington, United States

UW - Seattle AVEG

Seattle, Washington, United States

Countries

United States

Other Identifiers

10581

Identifier Type: REGISTRY

Identifier Source: secondary_id

AVEG 032

Identifier Type: -

Identifier Source: org_study_id