Safety of and Immune Response to an Investigational HIV-1 Vaccine With or Without Interleukin-12 (IL-12) in HIV-1 Infected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Therapeutic HIV vaccines are designed to control HIV infection by boosting the body's natural
      immune response. There are currently no FDA-approved therapeutic HIV vaccines. This study
      will test whether giving an HIV-1 vaccine together with or without interleukin 12 (IL-12) is
      safe and effective. This study will also test a new way of giving the vaccine called
      electroporation (EP).
    

Detailed description: 
      Although highly active antiretroviral therapy (HAART) has greatly reduced HIV
      infection-related morbidity and mortality, individual response to therapy can be variable.
      Therapeutic vaccination works by augmenting virus-specific immunity and can be given with or
      without immunomodulatory agents or adjuvants. In conjunction with HAART, therapeutic
      vaccination may be a more effective treatment for the suppression of HIV-1 replication. This
      study will examine the safety and efficacy of giving an investigational vaccine with or
      without IL-12 in HIV-1 infected adults receiving HAART. This study will also test whether
      delivering the vaccine using EP is safe and increases the efficacy of the vaccine.

      Participation in this study will last approximately 36 weeks. Participants will be randomly
      assigned to one of five cohorts. Cohort 1 will receive the HIV multi-antigen plasmid DNA (HIV
      MAG pDNA) vaccine or placebo intramuscularly (IM) in the upper arm followed by EP. Cohorts 2
      through 4 will receive the HIV MAG pDNA vaccine and sequentially increasing doses of GENEVAX
      IL-12 pDNA or placebo by IM/EP. Cohort 5 will receive the HIV MAG pDNA vaccine with the
      highest dose of IL-12 pDNA or placebo by needle and syringe in the upper arm.

      Participants receive two injections at Weeks 0, 4, and 12. Participants will complete a
      questionnaire that assesses the acceptability of the vaccine and remain at the clinic 30
      minutes for observation after each vaccination. Participants will be contacted by telephone 2
      to 3 days post-vaccination to assess vaccination-related signs and/or symptoms. All
      participants will be asked to record their temperatures and any symptoms they experience
      daily for 4 days following each vaccination on a Vaccination Report Card (VRC). All nonstudy
      vaccines or medications should also be recorded on the VRC. Study visits will occur at Weeks
      0, 1, 2, 4, 5, 6, 8, 12, 13, 14, 16, 24, and 36. At most visits, participants will undergo a
      physical examination. Women of reproductive potential will also undergo pregnancy testing
      before receiving injections on Weeks 0, 4, and 12. Blood will be drawn at various time points
      to evaluate participants' health and measure immunologic markers, CD4 and CD8 T-cell counts,
      and cytokine levels. Blood and plasma will also be stored for future exploratory studies.
    

Intervention name(s): Profectus HIV MAG pDNA vaccine; IL-12; Placebo
Intervention type(s): Biological; Biological; Other
Intervention description(s): 3,000 mcg admixture of two vaccine plasmids: ProfectusVax DNA Plasmid (HIV-1 gag/pol) and ProfectusVax DNA Plasmid (HIV-1 nef/tat/vif, env) at Weeks 0, 4, and 12; Administered at Weeks 0, 4, and 12; Saline injections at Weeks 0, 4, and 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Interleukin-12; Electroporation; HIV Therapeutic Vaccine