A Safety and Immunogenicity Trial of IHV01
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: 300 ug FLSC vaccine; 150 ug FLSC vaccine; 75 ug FLSC vaccine; Placebo
Intervention description: FLSC vaccine 300 ug (1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168; FLSC vaccine 150 ug (0.5 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168; FLSC vaccine 75 ug (0.25 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168; Placebo sterile saline (0.25 - 1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: vaccine; healthy volunteer

Summary:

      This study is designed to evaluate the safety of the FLSC vaccine and will be a randomized,
      placebo-controlled, modified double-blinded dose escalation study in 60 healthy adult
      volunteers (Human Immunodeficiency Virus-1 uninfected).
    

Eligibility criteria:

        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)