HIV Infections, HIV Seronegativity
Conditions
Keywords
Injections, Intradermal, Injections, Intramuscular, HIV Antibodies, Immunity, Cellular, AIDS Vaccines, HIV Seronegativity, Dose-Response Relationship, Immunologic, Vaccines, DNA, Immunity, Mucosal
Brief 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.
Detailed description
Volunteers receive either intradermal or intramuscular injections of GENEVAX-HIV; humoral and cellular responses are assessed accordingly.
Interventions
BIOLOGICALAPL 400-003
Sponsors
Wyeth-Lederle Vaccines
Study design
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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)
Countries
United States
Outcome results
None listed