a phase i safety and immunogenicity trial of live recombinant canarypox alvac-hiv (vcp205) and hiv-1 sf-2 rgp120 in hiv-1 uninfected volunteers to evaluate accelerated vaccine schedules

Conditions: HIV Infections

Summary: to evaluate the safety and immunogenicity of an accelerated schedule of recombinant canarypox vaccine alvac-hiv mn120tmg (vcp205) versus control followed by boost with rgp120/hiv-1 sf2 vaccine in hiv-negative volunteers. frequent injections of alvac-hiv vcp205 may result in more rapid induction of cytotoxic t-lymphocytes. this trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of alvac-hiv vcp205.

frequent injections of alvac-hiv vcp205 may result in more rapid induction of cytotoxic t-lymphocytes. this trial will evaluate whether an accelerated vaccination schedule can produce immunological responses comparable to those obtained in other trials of alvac-hiv vcp205. volunteers are randomized to receive immunization with either alvac-hiv vcp205 or alvac-rg rabies glycoprotein (vcp65) at days 0, 7, 14, and 21, followed by boost with rgp120/hiv-1 sf2 at days 28 and 84. a third cohort receives alvac-hiv vcp65 on the same schedule followed by boost with placebo.

Eligibility criteria:
inclusion criteria volunteers must have: * normal history and physical exam. * negative elisa and western blot for hiv. * cd4 count \>= 400 cells/mm3. * normal urine dipstick with esterase and nitrite. * lower-risk sexual behavior. exclusion criteria co-existing condition: volunteers with the following symptoms or conditions are excluded: * positive hepatitis b surface antigen. * medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance. * occupational responsibilities that preclude compliance. * active syphilis. note: subjects with serology documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible. * active tuberculosis. note: subjects with a positive ppd and a normal chest x-ray showing no evidence of tb and not requiring isoniazid therapy are eligible. * allergy to egg products or neomycin. * occupational exposure to birds. volunteers with the following prior conditions are excluded: * history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. * history of anaphylaxis or other serious adverse reactions to vaccines. * prior immunization against rabies. * history of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., stevens-johnson syndrome, bronchospasm, or hypotension). * prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance. * history of cancer unless there has been surgical excision that is considered to have achieved cure. prior medication: excluded: * live attenuated vaccines within 60 days prior to study entry. note: medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from hiv immunizations. * experimental agents within 30 days prior to study entry. * prior hiv vaccines. * prior rabies immunization. prior treatment: excluded: * blood products or immunoglobulin within 6 months prior to study entry. identifiable high-risk behavior for hiv infection, such as * injection drug use within past 12 months. * higher- or intermediate-risk sexual behavior.

Keywords: vaccines, synthetic hiv envelope protein gp120 aids vaccines hiv seronegativity avipoxvirus hiv preventive vaccine