A Phase I, Randomized, Double-Blind, Placebo-Controlled, Clinical Trial to Compare the Safety and Immunogenicity of Recombinant Envelope Protein rgp120/HIV-1SF2 (BIOCINE) Combined With Seven Adjuvants in Healthy HIV-1 Uninfected Individuals
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine in healthy HIV-negative volunteers the safety and immunogenicity of
      rgp120/HIV-1SF2 (BIOCINE) formulated with each of seven adjuvants.

      PER AMENDMENT 3/6/96: Purpose of the extension study - To determine the ability of
      immunization with rgp 120/SF-2 to induce an HIV-1 envelope-specific delayed-type
      hypersensitivity (DTH) response in volunteers who receive rsgp 120/MN skin testing.

      One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine
      the immunogen with an adjuvant. Adjuvants may augment vaccine immunogenicity by several
      mechanisms, and as a result induce a more favorable antibody response with high titers, which
      appear earlier in the course of immunization and persist over time.
    

Detailed description: 
      One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine
      the immunogen with an adjuvant. Adjuvants may augment vaccine immunogenicity by several
      mechanisms, and as a result induce a more favorable antibody response with high titers, which
      appear earlier in the course of immunization and persist over time.

      Volunteers are randomized to receive 50 mcg rgp120/HIV-1SF2 in combination with one of seven
      different adjuvants: aluminum hydroxide (alum), monophosphoryl lipid A, liposome-encapsulated
      monophosphoryl lipid A, MF59, MTP-PE/MF59, Syntex adjuvant formulation (SAF/2), and SAF/2
      plus threonyl muramyl dipeptide (threonyl MDP). An additional placebo control arm of
      volunteers receive alum only. Doses are administered at 0, 2, and 6 months. Volunteers are
      followed for 1 year after the last immunization. Per 8/5/94 amendment, eligible volunteers
      except those who received monophosphoryl lipid A for the first three immunizations may
      receive a fourth dose at month 15.

      PER AMENDMENT 3/6/96: Extension Study- Protocol 015 has been modified to add a special DTH
      study. At the end of the study, on day 784, intradermal injections of MN rsgp 120 will be
      administered to consenting volunteers who have received 4 immunizations as part of protocol
      015. Follow up will be extended to 56 days after administration of the intradermal
      injections.
    

Intervention name(s): Aluminum hydroxide; Lipid A, Monophosphoryl; Lipid A, Liposome-encapsulated monophosphoryl; Syntex adjuvant formulation; MF59; Threonyl Muramyl Dipeptide; rgp120/HIV-1 SF-2; MTP-PE/MF59
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide; MF59 oil emulsion; Acetylmuramyl-Alanyl-Isoglutamine
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Drug Therapy, Combination; Adjuvants, Immunologic; HIV Envelope Protein gp120; Acetylmuramyl-Alanyl-Isoglutamine; monophosphoryl lipid A; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine