A Phase I Clinical Trial to Evaluate: Part A. The Safety of MTP-PE/MF59 Adjuvant Emulsion. Part B. The Safety and Immunogenicity of Env 2-3, a Yeast Derived Recombinant Envelope Protein of Human Immunodeficiency Virus-1, in Combination With MTP-PE/MF59
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety of a fixed antigen dose with an increasing dose of adjuvant
      (MTP-PE/MF59, a substance to enhance the immune response to vaccine) in volunteers. To
      evaluate local and systemic reactions (Part A). To determine the safety and immunogenicity of
      Env 2-3 in combination with MTP-PE/MF59 in volunteers (Part B). The vaccine Env 2-3 is
      created from one of the viral proteins that make up HIV called envelope glycoprotein gp120. A
      problem with many immunogens, including candidate HIV vaccines, is that they may evoke
      relatively weak immune responses, particularly in humans and in nonhuman primates. Thus,
      there is considerable interest in the development of "adjuvants" (substances that augment
      immune responses to vaccines). MTP-PE/MF59 is an adjuvant that appears to be particularly
      promising, and is selected for the studies with this HIV vaccine candidate.
    

Detailed description: 
      The vaccine Env 2-3 is created from one of the viral proteins that make up HIV called
      envelope glycoprotein gp120. A problem with many immunogens, including candidate HIV
      vaccines, is that they may evoke relatively weak immune responses, particularly in humans and
      in nonhuman primates. Thus, there is considerable interest in the development of "adjuvants"
      (substances that augment immune responses to vaccines). MTP-PE/MF59 is an adjuvant that
      appears to be particularly promising, and is selected for the studies with this HIV vaccine
      candidate.

      This study is being conducted in two parts: Part A examines the safety of the adjuvant
      MTP-PE/MF59 alone; Part B examines the safety and immunogenicity of Env 2-3 in combination
      with MTP-PE/MF59. In Part A, three volunteers receive MTP-PE/MF59, and one volunteer receives
      emulsion alone at each dose level. Initiation of each dose level is separated by at least 72
      hours. Doses of adjuvant emulsion are administered at day 0 and day 30 for the highest
      tolerated dose. If significant reactions are encountered, additional subjects may be studied
      at lower doses. In Part B, six doses of MTP-PE adjuvant (0, 5, 10, 25, 50, or 100 mcg) in the
      MF59 emulsion are studied. Six volunteers receive Env 2-3/MTP-PE/MF59 and two receive
      MTP-PE/MF59 alone at each dose level. There is a minimum 1-week interval between dose
      escalations. Per amendment, volunteers may receive an additional dose of Env 2-3 or placebo
      in MF59 emulsion only, administered 12-18 months post initial inoculation.
    

Intervention name(s): MTP-PE/MF59; Env 2-3
Intervention type(s): Biological; Biological
Allocation: Randomized
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Drug Evaluation; Adjuvants, Immunologic; AIDS Vaccines; HIV Preventive Vaccine