a phase i trial to evaluate the safety and immunogenicity of the ubi hiv-1mn pnd peptide immunogen, given by im injection, in combination with the ubi microparticulate monovalent hiv-1 mn branched peptide given orally, in hiv-1 uninfected volunteers.

Conditions: HIV Infections

Summary: to evaluate safety and immunogenicity of 2 different hiv-1 peptide candidate vaccines, the ubi hiv-1 mn pnd peptide immunogen and the ubi microparticulate monovalent hiv-1 mn branched peptide when administered sequentially by 2 different routes of immunization, parental priming followed by oral boosting.

after the prescreening, volunteers will be randomized into group i or group ii. each group will contain 16 volunteers. at least 5 volunteers in each group must be women. at month 0 all volunteers will receive multivalent hiv-1 peptide immunogen or the placebo. group i will receive the injection in the deltoid and group ii will receive it in the anterior thigh. at months 1, 2 and 8 all patients will receive microparticulate monovalent hiv-1 peptide or the placebo. follow up will be conducted.

Eligibility criteria:
inclusion criteria patients must have or be: * healthy. * negative elisa for hiv. * negative for hepatitis b surface antigen. * normal urine dipstick. * normal history and physical exam. * availability for follow-up for planned duration of the study (60 weeks). risk behavior: required: * lower or intermediate 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. * active syphilis. note: if the serology is documented to be a false positive or due to a remote (\> 6 months) treated infection, the volunteer is eligible. * 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 or autoimmune disease. * history of anaphylaxis or other serious adverse reactions to vaccines. * history of inflammatory gastrointestinal disease, celiac disease or intestinal malignancy. * history of acute gastroenteritis within the past month or gastrointestinal surgery within the past 12 months. 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. * receipt of blood products or immunoglobulin in the past 6 months. * prior receipt of hiv vaccines or a placebo recipient in an hiv vaccine trial. 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 to enrollment. * higher risk sexual behavior as defined by aveg.

Keywords: vaccines, synthetic hiv-1 aids vaccines hiv seronegativity hiv preventive vaccine