A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
Condition: HIV Infections
MeSH terms: HIV Seropositivity
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety and immunogenicity of vaccinia-derived HIV-1 recombinant envelope
      glycoprotein (gp160) in asymptomatic HIV-infected adult volunteers. To compare safety and
      immunogenicity of two different schedules of gp160 administration. To examine the effects of
      gp160 and hepatitis B vaccine (Engerix-B) on various markers of viral load and on selected
      immune parameters.

      Potentiation of a patient's immune response to HIV might possibly prolong the period of
      clinical latency and protect the patient indefinitely. Preliminary results from a study of
      Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that
      the vaccine is safe and produces antibodies against the virus. Because another previous study
      failed to demonstrate a specific anti-HIV response in patients injected with a recombinant
      vaccinia virus containing HIV-1 genes, this study is also testing the immunotherapeutic role
      of other immunizations (such as hepatitis B vaccination) that would be expected to induce a
      nonspecific immune response in HIV-infected persons.
    

Detailed description: 
      Potentiation of a patient's immune response to HIV might possibly prolong the period of
      clinical latency and protect the patient indefinitely. Preliminary results from a study of
      Immuno-AG recombinant gp160 vaccine in healthy volunteers not infected with HIV suggest that
      the vaccine is safe and produces antibodies against the virus. Because another previous study
      failed to demonstrate a specific anti-HIV response in patients injected with a recombinant
      vaccinia virus containing HIV-1 genes, this study is also testing the immunotherapeutic role
      of other immunizations (such as hepatitis B vaccination) that would be expected to induce a
      nonspecific immune response in HIV-infected persons.

      Fifty-five healthy HIV-positive volunteers are randomly assigned to one of the following
      treatment arms: six injections (arm I) or four injections (arm II) of HIV-1 gp160 vaccine,
      four injections of hepatitis B vaccine as a non-HIV viral vaccine control (arm III), or six
      placebo injections consisting of the adjuvant vehicle used for the gp160 vaccine (arm IV).
      Immunizations or placebo are given at 4-week intervals for 5 months. To maintain blinding,
      adjuvant vehicle placebo is administered on days 84 and 112 to those volunteers receiving
      four instead of six vaccine injections (arms II and III). Volunteers are followed at 4-month
      intervals for 2 years.
    

Intervention name(s): gp160 Vaccine (Immuno-AG); Hepatitis B Vaccine (Recombinant)
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Primary purpose: Treatment
Keywords: Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; HIV-1; HIV Envelope Protein gp160; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; AIDS Vaccines; HIV Therapeutic Vaccine