Evaluating the Safety and Immunogenicity of PENNVAX®-GP DNA Vaccine and IL-12 Plasmid, Delivered Via Intradermal or Intramuscular Electroporation in Healthy, HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and
      interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM)
      injection with electroporation (EP), in healthy, HIV-uninfected adults.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and tolerability of the PENNVAX®-GP HIV-1
      DNA vaccine and IL-12 DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection
      with electroporation (EP), in healthy, HIV-uninfected adults. All study injections will be
      given using an EP device, which uses an electric pulse to briefly open tiny pores in the
      cells. Researchers will evaluate whether EP increases the immune response to the vaccine.

      The study will enroll participants in four groups. Within each group, participants will be
      randomly assigned to receive the PENNVAX®-GP DNA vaccine/IL-12 DNA adjuvant or placebo. Each
      group will receive different doses of the vaccine. Enrollment will begin with Group 1, which
      will receive a low dose of the vaccine and adjuvant. Study staff will review safety data from
      Group 1 before enrolling people in Groups 2, 3, and 4 at higher doses. Participants in all
      groups will receive injections at study entry (Day 0) and Months 1, 3, and 6. At each
      injection visit, participants in Groups 1 and 4 will receive injections in one arm, and
      participants in Groups 2 and 3 will receive injections in both arms. Groups 1, 2, and 3 will
      receive ID injections, and Group 4 will receive IM injections.

      Participants will attend study visits at Day 0, Week 2, and Months 1, 1.5, 3, 3.5, 6, 6.5, 9,
      and 12. Visits will include physical examinations, urine collection, blood collection, HIV
      and risk reduction counseling, and assessments and questionnaires. Some participants may have
      photographs taken of the injection site (this is optional). Study staff will contact
      participants at Month 18 for follow-up health monitoring.
    

Intervention name(s): PENNVAX®-GP HIV-1 DNA vaccine; Interleukin-12 (IL-12) DNA adjuvant; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.; Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.; Sterile Water for Injection, USP. Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.
Intervention MeSH terms: Interleukin-12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention