A Safety and Immunogenicity Trial of IHV01

Inclusion Criteria

• Age: 18 to 45 years of age.
• Sex: Male or Female (female volunteers of child bearing potential must have a negative serum beta human chorionic gonadotropin (b-HCG or pregnancy) test at time of screening and entry into the study and provide assurance of the use of effective(as judged by the investigator) birth control methods or abstinence beginning at least 60 days prior to the study and during the study
• Documented HIV-1 negative by ELISA
• Be in good general health without clinically significant medical history, physical examination findings, or clinically significant abnormal laboratory results (i.e., chronic medical conditions as noted in the exclusion criteria such as cancer as well as any conditions that in the opinion of the investigator might pose a risk to the volunteer)
• No identifiable risk factor for acquisition of HIV infection (i.e., intravenous drug use/needle sharing, unprotected sex with multiple partners)
• Negative b-HCG pregnancy test on the day of initial vaccination.
• Negative screen for Hepatitis B surface antigen (HBsAg);
• Negative screen for antibodies to Hepatitis C virus (Patient may enroll if patient can provide documentation of negative hepatitis C viral load.)
• 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
• Laboratory parameters must be within pre-specified limits as defined by exclusion criteria.
• Volunteers must be willing and able to provide written informed consent to participate in the study.
• Available for at least 48 weeks of follow-up.

Exclusion Criteria

• 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)
• Volunteers with an acute and clinically significant medical event (as determined by the investigator) within the past 30 days of screening.
• Have active tuberculosis or other systemic infectious process by review of systems and physical examination
• Have a history of immunodeficiency, autoimmune disease, or use of immunosuppressive medications
• Current treatment for malignancy other than basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• Is pregnant
• History of any chronic illness that would interfere with conduct or completion of study(as determined by the investigator)
• 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
• Have occupational or other responsibilities that would prevent completion of participation in the study
• Have received any live, attenuated vaccine except rabies vaccine within 60 days of study entry
• 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
• Have used experimental therapeutic agents within 30 days of study entry
• Have received blood products or immunoglobulins in the past 12 weeks
• Have a history of anaphylaxis or other serious adverse reactions to vaccines
• Have previously received an HIV vaccine
• Volunteers with any of the following laboratory parameters at the screening visit (within 30 days of immunization): Hemoglobin 2.0 mg/dL; aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the upper limits of normal; total bilirubin > 1.5 mg/dL
• Pregnant women or women who are breast-feeding; female volunteers of childbearing potentia