Safety and Immunogenicity Study of tgAAC09, a Gag-PR-RT AAV HIV Vaccine (A001)

Inclusion Criteria:

• Healthy males and females
• Age at least 18 years on the day of screening and no greater than 50 years on the day of vaccination
• Available for follow-up for the planned duration of the study (screening plus 12 months)
• Able to give written informed consent;
• No reported high-risk behavior for HIV (Appendix C), willing to undergo HIV testing and receive results;
• If sexually active, willing to use or have partner use condoms from screening until at least 4 months after the vaccination. Additional means of contraception are permitted and encouraged.

Exclusion Criteria:

• Clinically relevant abnormality on history or examination including history of immunodeficiency or use of immunosuppressive medication in last 6 months;
• A chronic medical condition or concurrent condition, which, in the opinion of the investigator, would make the volunteer unsuitable for the study.
• Any of the following abnormal laboratory parameters that are mild and judged to be clinically significant by the principal investigator or designee, or moderate, severe, or very severe: hematology (hemoglobin, absolute neutrophil count [ANC] absolute lymphocyte count [ALC], absolute CD4 count, platelets); urinalysis, clinical chemistry (total bilirubin, creatinine, AST, ALT). Refer to Appendix D for the grading of these laboratory parameters.
• If female, pregnant or planning a pregnancy within 4 months after receiving the vaccine, or lactating;
• Receipt of live attenuated vaccine within 60 days or other vaccine within 14 days of vaccination;
• Receipt of other experimental HIV vaccine at any time;
• Receipt of blood transfusion or blood products within 6 months of vaccination;
• Participation in another clinical trial of an investigational product currently or within 12 weeks of vaccination, or expected during participation in this study;
• History of severe local or systemic reaction to vaccination or history of allergic reactions to vaccines;
• Confirmed infection with HIV-1 or HIV-2;
• Positive for hepatitis B (surface antigen), hepatitis C antibodies, or active syphilis (confirmed by treponemal test such as TPHA in addition to non-treponemal test such as RPR) or active tuberculosis.
• Unlikely to comply with protocol.