A Phase I Study of Safety and Immunogenicity of the WRAIR HIV-1 Vaccine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety of LFn-p24 administered at three different doses with Alhydrogel given
      intramuscularly

      To evaluate immune responses to LFn-p24 with Alhydrogel at three different doses given
      intramuscularly
    

Detailed description: 
      The study seeks to enroll healthy, vaccine naïve volunteers, 18 through 45 years old.
      Recruitment consists of using flyers, newspaper advertising, radio, and direct mailing at
      local military installations, targeting the general population of the greater Washington D.C.
      area.

      The study's primary objective is the safety and tolerability of Lfn-p24 given IM.

      Volunteers will be screened (visit 1) and enrolled within 2 to 12 weeks prior to the first
      vaccination. Study volunteers will receive a briefing from the Principal Investigator (PI) or
      a sub investigator. The briefing is followed by an opportunity for questions from the
      volunteers. The PI or designee will then review the consent form with potential volunteers
      (visit 1) and answer any questions. After review, an Informed Consent will be signed and a
      "Test of Understanding" will be completed by all volunteers, prior to enrollment in the
      study. A second pre-screening visit (visit 2) will occur 3 - 30 days prior to the first
      vaccination (visit 3) to confirm eligibility for vaccination. During this visit each
      volunteer will have an opportunity to ask questions about the study.

      On the day of vaccination (visits 3, 6, and 10), volunteers will be observed for 30 minutes
      following injection for acute adverse experiences and will be contacted the day following
      injection for a brief adverse reaction interview. In addition, volunteers will complete
      diaries for 7 days following each vaccination and will be evaluated by a clinical
      investigator if significant symptoms are reported. Adverse effects and laboratory
      abnormalities will be tabulated. Routine measurements of hematology, serum chemistry, and
      urinalysis laboratory tests will be performed in subsequent safety and general follow up
      visits.renee

      LFn-p24 with Alhydrogel adjuvant will be delivered IM in the deltoid muscle at the intervals
      shown below. Groups will be enrolled in staggered fashion beginning with the lowest dose
      group. The subsequent groups receiving higher doses will then be enrolled by the investigator
      if the second injection of the immediate lower dose is shown to be safe and well tolerated (<
      grade II toxicity), after the 2 week post vaccination follow-up visit.

      IMMUNIZATION SCHEDULE

      Group I Subjects *6 0:150µg LFn-p24 Alhydrogel;4th Week:150µg LFn-p24 Alhydrogel; 16th
      Week:150µg LFn-p24 Alhydrogel; Group II Subjects *6 0:300µg LFn-p24 Alhydrogel; 4th Week:
      300µg LFn-p24 Alhydrogel; 16th Week: 300µg LFn-p24 Alhydrogel; Group III Subjects *6 0: 450µg
      LFn-p24 Alhydrogel; 4th Week: 450µg LFn-p24 Alhydrogel; 16th Week: 450µg LFn-p24 Alhydrogel

      *Six subjects per group includes 4 vaccines and 2 placebos.
    

Intervention name(s): HIV LFn-p24
Intervention type(s): Biological
Intervention description(s): HIV LFn-p24 is a combination of an Anthrax derived polypeptide Lethal factor (LFn), from which the toxin domain has been removed, and the HIV-1 gag p24 protein has been fused to LFn. Lfn-p24 is formulated in liquid form, and vialed at 200 µg/ml and 600 µglml. The product will be administered IM in doses ranging from 150µg to 450µg with Alhydrogel.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV; Lfn-p24; Anthrax; IM; HIV-1; HIV Preventive Vaccine