a phase i safety and immunogenicity trial of ubi hiv lipopeptide vaccine component p3c541b in hiv-1 seronegative human subjects

Conditions: HIV Infections

Summary: to evaluate an hiv synthetic lipopeptide candidate vaccine component, p3c541b, at two dose levels, administered subcutaneously (s.c.) in a randomized, double-blind, placebo controlled study.

the prospective volunteers will be screened and hla typed for class i mhc haplotypes. only volunteers possessing hla alleles a33, b8, b27, b35 or bw62 or any combination thereof will be enrolled in the study. subjects will be allocated to 1 of 2 study groups. group 1 will receive 70 mcg of p3c541b or the placebo and group ii will receive 350 mcg of p3c541b or the placebo. note: enrollment for group ii wil not begin until at least 5 group i participants have reached day 14 without serious adverse events.

Eligibility criteria:
inclusion criteria patients must have or be: * healthy * negative elisa for hiv. * one or more hla alleles: * a33, b8, b27, b35, or bw62. * negative for hepatitis b surface antigen. * normal urine dipstick. * normal history and physical examination. * availability for follow-up planned duration of the study (12 months). * viable ebv line prior to enrollment. risk behavior: required: * lower risk sexual behavior as defined by aveg. exclusion criteria co-existing condition: patients with any of the following symptoms or conditions are excluded: * medical or psychiatric condition or occupational responsibilities, which preclude subject compliance with the protocol (e.g., recent suicidal ideation or present psychosis). * active syphilis. note: if the serology is documented to be false positive due to a remote (\> 6 months) treated infection, the volunteer is eligible. * hepatitis b surface antigenemia. * active tuberculosis. note: volunteers with a positive ppd and a normal chest x-ray showing no evidence of tb and not requiring inh therapy are eligible. patients with any of the following prior conditions are excluded: * history of immunodeficiency, chronic illness, malignancy, autoimmune disease. * history of cancer, unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of a cure. * history of anaphylaxis or history of other serious adverse reactions to vaccines. * history of serious allergic reaction to any substance, requiring hospitalization or emergent medical care. * history of suicide attempts or past psychosis. prior medication: excluded: * history of use of immunosuppressive medication. * live attenuated vaccines within 60 days of study. note: * medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary but should be given at least 2 weeks away from hiv immunizations. * use of experimental agents within 30 days prior to study. prior treatment: excluded: * receipt of blood products or immunoglobulin in the past 6 months. risk behavior: excluded: * subjects with identifiable higher risk behavior for hiv infection as determined by screening questionnaire designed to identify risk factors for hiv infection. * history of injection drug use within the last 12 months prior to enrollment. * higher or intermediate risk sexual behavior as defined by aveg.

Keywords: vaccines, synthetic aids vaccines hiv seronegativity hiv preventive vaccine