A Safety and Immunogenicity Trial of IHV01

This is a Phase 1 randomized, placebo-controlled, modified double-blinded dose escalation
study in 60 healthy adult volunteers who are Human Immunodeficiency Virus-1 (HIV-1)
uninfected. Participants in the study will receive 4 injections at 0, 4, 8 and 24 weeks and
will be followed for an additional 24 weeks. The total study duration will be 48 weeks. As
this is a Phase 1 trial, the primary objective is to document safety of the Full Length
Single Chain (FLSC) gp120-CD4 complex vaccine with a secondary objective to evaluate immune
responses induced by the vaccine. This vaccine is being evaluated as it is constructed so
that the gp120 and CD4 moieties form a stable intra-chain binding interaction that forms a
transition state structure that presents conserved, conformational domains involved in the
early HIV replication process. It is hypothesized that antibodies directed to these epitopes
would be highly cross-reactive and potentially useful for HIV vaccine development.

Inclusion Criteria:

1. Age: 18 to 45 years of age.

2. 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

3. Documented HIV-1 negative by ELISA

4. 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)

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

10. Laboratory parameters must be within pre-specified limits as defined by exclusion
criteria.

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.

Exclusion Criteria:

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)