a study of genevax-hiv, a possible vaccine

Conditions: HIV Infections; HIV Seronegativity

Summary: the purpose of this study is to see if it is safe to give genevax-hiv, a potential hiv vaccine, to hiv-negative volunteers. the study also compares the effects of genevax-hiv injected into the muscle to the effects of the drug when injected into the skin.

volunteers receive either intradermal or intramuscular injections of genevax-hiv; humoral and cellular responses are assessed accordingly.

Eligibility criteria:
inclusion criteria patients must have: * good health. * ability to understand the basis of hiv transmission and other common sexual and blood-borne infections. * the following parameters within normal range: * hematopoietic: * total white blood cell, lymphocyte, granulocyte, and platelet count, hemoglobin and hematocrit. * renal: * bun and creatinine, urinalysis. * hepatic: * total serum bilirubin. * endocrine/metabolic: * serum calcium, serum glucose, total serum cpk. * immunologic: * total serum immunoglobulin and absolute cd4 count. * hepatitis b and hepatitis c negative. * urinalysis: * normal screen with dipstick for esterase and nitrite. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * hiv-seropositive status. * any positive result for anti-dna antibodies considered of potential clinical significance as measured by anti-dna antibody and/or anti-nuclear antibody (ana) assays. * any condition which, in the opinion of the principal investigator, might interfere with completion of the study or evaluation of the results. * known hypersensitivity to bupivacaine or any amide-type local anesthetic (such as lidocaine, dibucaine, mepivacaine, and prilocaine) or a history of anaphylaxis or other serious adverse reactions to vaccines. concurrent medication: excluded: any medication which may affect immune function with the exception of low doses of nonprescription-strength nsaids, aspirin, or acetaminophen for acute conditions such as headache or trauma. patients with the following prior conditions are excluded: * hiv-seropositive. * known or suspected history of impairment or abnormality in immune functioning. * exposure to potentially-infective hiv fluids within the prior 6 months or tested positive for hiv at any time. * history of any prior disease or therapy which would affect immune function including: * prior malignancy, except curatively-treated basal cell or squamous cell carcinoma in situ of the cervix. * immunodeficiency or autoimmune disease. * acute infection or a recent (within 6 months) history of chronic infection. * history of serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., stevens-johnson syndrome, bronchospasm, or hypotension). prior medication: excluded: cytotoxic chemotherapy that may affect immune function. prior treatment: excluded: * previous immunization with any experimental vaccines directed against hiv or receipt of any experimental agent within 30 days prior to enrollment. * receipt of any blood products or immunoglobulin within 6 months prior to enrollment. * exposure to live attenuated vaccines within 60 days of study. * radiotherapy that may affect immune function. risk behavior: excluded: * active drug or alcohol abuse or uncontrolled (unstable) psychiatric disorders which, in the opinion of the investigator, would interfere with study participation. * higher- or intermediate-risk sexual behavior (aveg criteria)

Keywords: injections, intradermal injections, intramuscular hiv antibodies immunity, cellular aids vaccines hiv seronegativity dose-response relationship, immunologic vaccines, dna immunity, mucosal