Safety of and Immune Response to a DNA Vaccine and a Recombinant HIV-1-MVA Vaccine, Separately and in Combination, in Healthy Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of and immune response to two
      experimental vaccines, designed for use in combination, for the prevention of HIV infection
      in healthy adults.
    

Detailed description: 
      The worldwide HIV/AIDS epidemic may only be controlled through the development of a safe and
      effective vaccine that will prevent HIV infection. DNA-based vaccines alone promote a weak
      immune response but when used as priming immunogens, followed by a recombinant viral vaccine
      that is a very attenuated vaccinia (smallpox) vaccine presenting the same immunogens as a
      booster, immunization with such a combination regimen seems to induce much stronger
      responses. EP-1233 is a DNA-HIV-recombinant vaccine designed to interact with CD4
      (helper-inducer) and CD8 (cytotoxic) T lymphocytes (T cells) to prime CD4 and CD8 cells to
      respond to HIV components. MVA-mBN32 is a HIV-recombinant viral (MVA) vaccine that through
      other ways of interacting with CD4 and CD8 cells to immunize (boost) with similar HIV
      immunogens, may result in a stronger immune response.

      The purpose of this study is to determine the safety of and immune response to two
      experimental vaccines for the prevention of HIV infection, individually and in combination,
      in healthy adults who have not been previously vaccinated against smallpox. Participants will
      be randomly assigned to one of three groups. All participants will receive injections at Days
      0, 28, 84, and 168 of the study. Participants assigned to Group 1 will receive, on Day 0, one
      injection in each arm of EP-1233 or placebo and the same study product (EP-1233 or the DNA
      placebo) on Day 28. Thereafter, each Group 1 participant will receive one injection of
      MVA-mBN32 or placebo on Days 84 and 168. Groups 2 and 3 will not begin enrollment until
      safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to
      Group 2 will receive only the DNA vaccine EP-1233 (or placebo) in each arm on all injection
      days. Participants in Group 3 will not begin enrollment until safety and immunogenicity data
      from Group 1 have been evaluated. Participants assigned to Group 3 will receive a consistent
      regimen of MVA-mBN32 (or placebo) on all injection days. Participants will be required to
      keep a symptom log for 3 days after each injection and attend clinical visits on Day 0, 14,
      28, 42, 84, 98, 168, 182, 273, and 364 of the study. At each of the 10 visits, a physical
      exam, cardiac assessment, and HIV risk reduction and prevention counseling will occur. Blood
      collection will occur on Days 0, 14, 42, 98, 182, 273, and 364. Urine collection will occur
      on Days 14, 42, 98, and 182.
    

Intervention name(s): EP-1233; MVA-mBN32
Intervention type(s): Biological; Biological
Intervention description(s): DNA-HIV-recombinant vaccine; HIV-recombinant viral vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV Seronegativity; EP1233; MVA-mBN32; HIV Preventive Vaccine