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

November 2, 1999
May 16, 2012
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Complete list of historical versions of study NCT00000946 on ClinicalTrials.gov Archive Site
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A Study to Test the Safety of Three Experimental HIV Vaccines
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]

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Prevention
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
March 2001
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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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00000946
AVEG 032, 10581
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National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
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Study Chair: Mark J Mulligan, MD Univ of Alabama at Birmingham
National Institute of Allergy and Infectious Diseases (NIAID)
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP