A Study to Test the Safety of Three Experimental HIV Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000946
First received: November 2, 1999
Last updated: May 16, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
HIV Infections
HIV Seronegativity
Biological: HIV p24/MF59 Vaccine
Biological: ALVAC-HIV MN120TMG (vCP205)
Biological: ALVAC-RG Rabies Glycoprotein (vCP65)
Biological: rgp120/HIV-1 SF-2
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Phase I Trial to Evaluate the HIV-1 SF-2 Recombinant p24 Subunit Vaccine [Chiron Vaccines] Administered as a Novel Boost in "Prime-Boost" Vaccination Regimens With ALVAC-HIV vCP205 [Pasteur Merieux Connaught] and HIV-1 SF-2 rgp120 in MF59 [Chiron Vaccines]

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 40
Study Completion Date: March 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000946

Locations
United States, Alabama
UAB AVEG
Birmingham, Alabama, United States, 35294
United States, Maryland
JHU AVEG
Baltimore, Maryland, United States, 21205
United States, Missouri
St. Louis Univ. School of Medicine AVEG
Saint Louis, Missouri, United States, 63110
United States, New York
Univ. of Rochester AVEG
Rochester, New York, United States, 14642
United States, Tennessee
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232
United States, Washington
FHCRC/UW Vaccine CRS
Seattle, Washington, United States, 98104
UW - Seattle AVEG
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Investigators
Study Chair: Mark J Mulligan, MD Univ of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000946     History of Changes
Other Study ID Numbers: AVEG 032, 10581
Study First Received: November 2, 1999
Last Updated: May 16, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Drug Evaluation
Drug Therapy, Combination
AIDS Vaccines
HIV Seronegativity
HIV Preventive Vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Krestin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 28, 2014