HIV-1 Vaccine Test in Uninfected Adult Volunteers

Inclusion Criteria

• •Participants must be between 18-60 years of age (no more than 10% of the volunteers to be over 50).
• •Male and female subjects are eligible. (For female participants: negative pregnancy test at the screening visit; for both male and female participants: agree to practice abstinence or use barrier contraception from the date of the first vaccination until 3 months after the final immunization.)
• •No significant findings on medical history, physical exam or screening lab studies as determined by clinic personnel
• •Willing to identify HIV infection risks and amenable to risk reduction counceling.
• •All subjects must understand the basis of transmission of HIV and agree to abstain from higher risk behavior for HIV infection.
• •Normal complete blood count and differential defined as:
• •Hematocrit greater than or equal to 34 percent for women and 38 percent for men; White blood cell count greater than or equal to 3,500/mm(3) and less than or equal to 10,000/mm(3) with no significant findings on differential; Total lymphocyte count greater than or equal to 800 cells/mm(3); Absolute CD4 count greater than or equal 400 cells/mm(3); Platelets 150,000-550,000 cells/cm(3).
• •Normal ALT and AST (less than or equal to 1.5 times institutional upper limit) and creatinine (less than or equal to 1.6 mg/dl).
• •Normal or low positive ANA titer (1 to 3 EU) if there is no clinical evidence of underlying disorders that are associated with a positive ANA, if no first degree relative has an autoimmune disease, and if anti-ENA antibodies are negative
• •Negative anti-dsDNA antibodies
• •Normal IgG levels
• •CPK less or equal to 2 times institutional upper limit
• •No significant findings on urinalysis
• •No significant findings on chest x-ray
• •Negative RPR (unless determined to be a false positive or a positive result is due to a prior-greater than 6 month-treated infection)
• •Negative for Hepatitis B surface antigen and anti-hepatitis C antibody
• •Negative for HIV by ELISA and DNA-PCR (below the limit of detection of the assay used) within 4 weeks of immunization (note that if a potential subject will not be allowed on study until further studies--potentially including repeat ELISAs, RT-PCR and DNA PCR--demonstrate that the subject is not infected with HIV)
• •Availability for follow-up for planned duration of the study (12 months)
• •Give informed consent by signing the Institutional Review Board (IRB) approved informed consent form(s)
• •Willingness to have samples stored and to have HLA testing
• •Treatment with immunomodulators, except for NSAIDS, within 14 days prior to enrollment
• •Skin disease (e.g., eczema, psoriasis) affecting areas of immunization that precludes immunization