Evaluating the Safety of and Immune Response to HIV-MAG DNA Vaccine With or Without Plasmid IL-12 Adjuvant Delivered Intramuscularly Via Electroporation Followed by VSV-gag HIV Vaccine Boost in Healthy, HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Some vaccines may work better when given together with another substance known as an adjuvant
      or when given with an experimental procedure called electroporation (EP). EP is a method
      where an electric pulse is administered to the same muscle where the vaccine injection is
      given. The addition of the adjuvant to the vaccine and the delivery with EP may increase a
      person's immune response to the vaccine. Combination approaches such as a DNA vaccine
      followed by live vector boost may also increase a person's immune response to the vaccine
      components. All of these interventions will be tested in this study.

      This study will evaluate the safety and tolerability of and immune response to an HIV DNA
      vaccine with or without plasmid IL-12 adjuvant, when given by EP and followed by a live
      vector vaccine given IM by needle and syringe in healthy, HIV-uninfected adults.
    

Detailed description: 
      The effectiveness of a vaccine may be increased when combined with an adjuvant and/or when
      given with EP. The addition of an adjuvant or EP may increase a person's immune response to a
      vaccine. Furthermore, the immune response to HIV antigens may be improved by giving a DNA
      vaccine boosted with a live vector vaccine. The purpose of this study is to evaluate the
      safety, tolerability, and immunogenicity of an HIV DNA vaccine (HIV-MAG) alone or in
      combination with an IL-12 pDNA adjuvant, delivered IM via EP followed by a Vesicular
      Stomatitis Virus (VSV) HIV gag vaccine boost given IM by needle and syringe in healthy,
      HIV-uninfected adults.

      Participants will be enrolled into the study in one of four groups. Each of the four groups
      will receive 3 mg of the HIV-MAG vaccine alone or combined with one of three different doses
      of the IL-12 pDNA adjuvant, followed by the VSV HIV gag vaccine boost. Within each of the
      four groups, participants will be randomly assigned to receive the study vaccines or placebo.
      At study entry (Day 0), all participants will undergo a physical examination and blood
      collection. Female participants will also take a pregnancy test. Participants will complete
      questionnaires and receive counseling on HIV risk reduction. They will also receive their
      first vaccination. Participants will remain in the clinic for 30 minutes after the
      vaccination for observation and monitoring.

      Additional vaccination study visits will occur at Months 1, 3, and 6. At Months 1 and 3,
      participants will receive the same vaccine or placebo they received at study entry; at Month
      6, participants will receive the VSV HIV gag vaccine or placebo. For 3 days after the study
      entry and Months 1 and 3 vaccination visits, participants will record their symptoms in a
      diary. After the Month 6 vaccination visit, participants will record their symptoms for 7
      days.

      Participants in Groups 1 and 3 will attend additional study visits on Days 1, 3, 14, 42, 91,
      98, 169, 171, 175, 182, 273, and 364. Participants in Groups 2 and 4 will attend additional
      study visits on Days 14, 42, 98, 182, 273, and 364. Most study visits will include a physical
      examination, blood collection, oral mucosa examination, interviews and questionnaires, and
      oral mucosa examination. If participant has any oral sores, oral swabs may be collected.
      Saliva also may be collected. Select study visits will include a mini mental state exam,
      urine collection, HIV testing, and risk reduction counseling. Study researchers will contact
      participants at Months 15, 24, and 36 for follow-up health monitoring.
    

Intervention name(s): HIV-MAG vaccine; IL-12 pDNA adjuvant; VSV HIV gag vaccine; Placebo; Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device
Intervention type(s): Biological; Biological; Biological; Biological; Device
Intervention description(s): Participants assigned to receive the HIV-MAG vaccine will receive 3 mg of the vaccine with bupivacaine, alone or admixed with one of three doses of the IL-12 pDNA adjuvant.; Participants assigned to receive the IL-12 plasmid (IL-12 pDNA) adjuvant will receive one of three doses (total of 250 mcg, 1000 mcg, or 1500 mcg) of the adjuvant admixed with the HIV-MAG vaccine.; Participants assigned to receive the VSV HIV gag vaccine will receive a total dose of 1x10^8 plaque-forming units (PFUs) administered as 5x10^7 PFU in 1 mL by IM injection in both the left and right deltoids at Month 6.; Placebo will consist of sodium chloride for injection, USP 0.9%.; The HIV-MAG vaccine, IL-12 pDNA adjuvant, and placebos for IL-12 pDNA adjuvant/HIV-MAG vaccines will be delivered IM into the deltoid by the Ichor Medical Systems TDS EP device.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention