A Phase I Safety and Immunogenicity Trial of Live Recombinant Canarypox-gp160 MN (ALVAC vCP125, HIV-1 gp160 MN) in HIV-1 Uninfected Adult Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A: To evaluate the safety and immunogenicity of ALVAC vCP125 HIV-1 gp160 MN live
      canarypox recombinant vaccine (ALVAC gp160 MN) versus a recombinant canarypox expressing the
      rabies glycoprotein (ALVAC rabies glycoprotein) as a control in healthy, HIV-1 uninfected
      adult volunteers.

      Part B: To evaluate the schedule of two immunizations with ALVAC gp160 MN for optimal
      immunogenicity.

      Amendment: 12/22/93: To determine whether ALVAC gp160 MN in combination with SF-2 rgp120
      subunit protein is capable of generating humoral and cellular immune responses of greater
      intensity and longer duration than either vaccine administered alone.

      A canarypox-vectored vaccine (ALVAC) that expresses the gp160 antigen of the HIV-1 MN strain
      might satisfy many criteria for an affordable HIV vaccine. Per 12/22/93 amendment: Cellular
      responses have been augmented by the combination of two recombinant vaccines, especially in
      vaccinia naive individuals.
    

Detailed description: 
      A canarypox-vectored vaccine (ALVAC) that expresses the gp160 antigen of the HIV-1 MN strain
      might satisfy many criteria for an affordable HIV vaccine. Per 12/22/93 amendment: Cellular
      responses have been augmented by the combination of two recombinant vaccines, especially in
      vaccinia naive individuals.

      In Part A, 28 healthy volunteers (15 vaccinia-immune and 13 vaccinia-naive) are randomized to
      receive intramuscular injections of ALVAC gp160 MN at a dose of 1 million TCID50 or ALVAC
      rabies glycoprotein as a control at months 0 and 2. In Part B, 90 healthy volunteers (60
      vaccinia immune and 30 vaccinia naive) are randomized to receive ALVAC gp160 MN at a dose of
      10 million TCID50 or ALVAC rabies glycoprotein control, on an immunization schedule of either
      month 0 and 1 or 0 and 2. For Part B, half of the patients receiving ALVAC gp160 MN, as well
      as approximately half of those receiving control vaccine, will receive booster immunizations
      with SF-2 rgp120 subunit protein, if available, at months 9 and 12; the other half will
      receive booster immunizations with the same preparation as they received for their first two
      immunizations. In Part A, all control volunteers except one within each control group receive
      SF-2 rgp120 subunit protein at months 9 and 12. An additional group of 10 volunteers will
      receive four injections of SF-2 rgp120 subunit protein at months 0, 1, 6 and 12. Part B will
      begin whenever the higher dose of ALVAC gp160 MN becomes available (at least 4 weeks after
      initiation of Part A). Volunteers are followed for at least 18 months. Per 06/10/94 addendum,
      volunteers will be contacted once or twice per year for at least 5 years to check on health
      status.
    

Intervention name(s): ALVAC-HIV gp160MN (vCP125); ALVAC-RG Rabies Glycoprotein (vCP65); rgp120/HIV-1 SF-2
Intervention type(s): Biological; Biological; Biological
Intervention MeSH terms: polysaccharide-K
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV Envelope Protein gp160; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; Avipoxvirus; HIV Preventive Vaccine