A Safety and Immunogenicity Trial of IHV01

Exclusion Criteria

• •5. No identifiable risk factor for acquisition of HIV infection (i.e., intravenous drug use/needle sharing, unprotected sex with multiple partners)
• •6. Negative b-HCG pregnancy test on the day of initial vaccination.
• •7. Negative screen for Hepatitis B surface antigen (HBsAg);
• •8. Negative screen for antibodies to Hepatitis C virus (Patient may enroll if patient can provide documentation of negative hepatitis C viral load.)
• •9. Participant must have a CD4 count ( a type of white blood cells) within the normal range of the clinical laboratory utilized for the study and a CD4 percentage within 20% of the normal range of the clinical laboratory
• •11. Volunteers must be willing and able to provide written informed consent to participate in the study.
• •12. Available for at least 48 weeks of follow-up.
• •1. High risk behavior for acquisition of HIV within 24 weeks of study entry(i.e., intravenous drug use/needle sharing, unprotected sex with multiple partners)
• •2. Volunteers with an acute and clinically significant medical event (as determined by the investigator) within the past 30 days of screening.
• •3. Have active tuberculosis or other systemic infectious process by review of systems and physical examination
• •4. Have a history of immunodeficiency, autoimmune disease, or use of immunosuppressive medications
• •5. Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• •6. Is pregnant
• •7. History of any chronic illness that would interfere with conduct or completion of study(as determined by the investigator)
• •8. Have evidence of psychiatric, medical and/or substance abuse problems during the past 24 weeks that the investigator believes would adversely affect the volunteer's ability to participate in the trial
• •9. Have occupational or other responsibilities that would prevent completion of participation in the study
• •10. Have received any live, attenuated vaccine except rabies vaccine within 60 days of study entry
• •11. Vaccine (FDA approved; e.g. influenza, pneumovax, etc) administration within 30 days of immunization with the study vaccine. NOTE: Medically indicated subunit or killed vaccines (e.g., Hepatitis A or Hepatitis B) should be given prior to trial initiation or after completion of the study immunizations. If patient requires immunization, injections should be given more than 2 weeks prior or 2 weeks after study immunization
• •12. Have used experimental therapeutic agents within 30 days of study entry
• •13. Have received blood products or immunoglobulins in the past 12 weeks
• •14. Have a history of anaphylaxis or other serious adverse reactions to vaccines
• •15. Have previously received an HIV vaccine
• •16. Volunteers with any of the following laboratory parameters at the screening visit (within 30 days of immunization): Hemoglobin \<10 (without having received a blood or red blood cell transfusion within 30 days prior to laboratory test); neutrophil count \<750 cells/mm3; platelet count \<50,000/mm3; serum creatinine \> 2.0 mg/dL; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 times the upper limits of normal; total bilirubin \> 1.5 mg/dL
• •17. Pregnant women or women who are breast-feeding; female volunteers of childbearing potential who are not using or willing to use an effective (as judged by the investigator) barrier contraceptive methods or abstinence while enrolled in this study.
• •18. Use of any immune modulators or suppressors within 45 days of study entry including but not limited to agents such as interleukins (e.g. IL-2), interferons (e.g. IFN-\*), high dose systemic steroids (e.g. ≥ 20 mg prednisone equivalent/day) for \> 30 days, thalidomide, filgrastim (G-CSF), sargramostim (GM-CSF), dinitrochlorobenzene (DNCB), thymosin alpha, thymopentin, inosiplex, polyribonucleoside, ditiocarb sodium, cyclosporin, mycophenolate mofetil, methotrexate, and cancer chemotherapy.
• •19. No other investigational agent within 30 days of study entry
• •20. Any other condition which, in the opinion of the investigator, might interfere with completion of the study or evaluation of the results
• •21. Have active Hepatitis B virus infection (positive HBsAg) or Hepatitis C infection(defined as positive antibodies)