A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived MN HIV-1 Recombinant Envelope Glycoprotein (rgp160) of Human Immunodeficiency Virus at Two Different Vaccination Schedules
Condition: HIV Infections; HIV Seronegativity
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      AMENDED 8/94: To expand the safety and immunogenicity profile of MN rgp160 vaccine
      (Immuno-AG) by administering a higher dose (800 mcg) at 0, 1, 6, and 12 months and 0, 2, 8
      and 14 months (these two schedules were compared in VEU 013A using a dose of 200 mcg). To
      obtain plasma following the fourth immunization. To evaluate skin test reactivity.

      ORIGINAL (replaced): To determine in healthy volunteers the safety and immunogenicity of two
      immunizations of MN rgp160 vaccine (Immuno-AG) in combination with a live recombinant
      vaccinia virus LAV HIV-1 gp160 vaccine (HIVAC-1e) versus DryVax (the standard smallpox
      vaccine that was used for many years) control in combination with placebo.

      ORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of
      HIV-1 in the United States, has been developed. A previous study showed that a combination
      vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160
      subunit vaccine, resulted in humoral and cellular immune responses of greater and longer
      duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN
      rgp160 vaccine merits investigation.
    

Detailed description: 
      ORIGINAL (replaced): A gp160 vaccine derived from the MN strain, the most prevalent strain of
      HIV-1 in the United States, has been developed. A previous study showed that a combination
      vaccine strategy, consisting of priming with HIVAC-1e followed by boosting with a gp160
      subunit vaccine, resulted in humoral and cellular immune responses of greater and longer
      duration than either vaccine alone. Thus, a live vector/subunit boost approach using the MN
      rgp160 vaccine merits investigation.

      AMENDED 8/94: Volunteers are randomized to receive 800 mcg MN rgp160 vaccine (Immuno-AG) or
      adjuvant control (placebo) on one of two dosing schedules. Sixteen volunteers receive
      candidate vaccine and four volunteers receive placebo.

      ORIGINAL (replaced): Volunteers are randomized to receive either HIVAC-1e on days 0 and 56
      followed by immunization with MN rgp160 vaccine on days 224 and 364, or DryVax control on
      days 0 and 56 followed by placebo on days 224 and 364. Ten volunteers are entered on the MN
      rgp160 vaccine arm and two volunteers on the placebo arm.

      PER AMENDMENT 7/96: Two additional booster immunizations of 600 mcg of MN rgp 120/HIV-1
      vaccine given at study months 22 and 24 to consenting St. Louis University volunteers.
    

Intervention name(s): gp160 Vaccine (Immuno-AG)
Intervention type(s): Biological
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; Smallpox Vaccine; HIV-1; HIV Envelope Protein gp160; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine