Evaluating the Safety and Immune Response to Three HIV Vaccine Schedules in Healthy, HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      NOTE: This study has stopped enrolling new participants, and all study vaccinations for
      currently enrolled participants have been stopped.

      Currently, there are no vaccines approved for the prevention of HIV infection, but there are
      many clinical trials taking place that are studying experimental HIV vaccines. The purpose of
      this study is to evaluate the safety and tolerability of three different HIV vaccine
      schedules in healthy, HIV-uninfected adults.
    

Detailed description: 
      NOTE: This study has stopped enrolling new participants, and all study vaccinations for
      currently enrolled participants have been stopped.

      This study will evaluate the safety and immune response to three different vaccine schedules
      of a DNA HIV vaccine (DNA-HIV-PT123) followed by a NYVAC HIV vaccine boost (NYVAC-HIV-PT1 and
      NYVAC-HIV-PT4) in healthy, HIV-uninfected adults. Study researchers will also evaluate the
      safety of administering the HIV vaccine on a shorter administration schedule.

      This study will take place in two parts. Participants in Part A of the study will receive the
      DNA HIV vaccine on a faster schedule than usual: at Days 0, 14, and 28. At study entry,
      participants will undergo a physical examination, HIV risk reduction counseling, and
      interviews and questionnaires. Female participants will take a pregnancy test. Study visits
      will occur at Days 0, 14, 28, 42, 140, and 224. These study visits will include some of the
      same procedures performed at study entry, as well as blood collection, urine collection, and
      HIV testing.

      Study researchers will evaluate participant data from Part A of the study, and if there are
      no safety concerns, they will enroll participants into Part B of the study. Participants in
      Part B of the study will be randomly assigned to one of three groups, and within each group,
      some participants will be randomly assigned to receive placebo vaccine. Participants will
      receive DNA HIV vaccine or placebo on Days 0, 14, and 28 (Group 2); or Days 0 and 28 (Group
      3); or Days 0, 28, and 56 (Group 4). The NYVAC HIV vaccine boost will be administered at Day
      84 (Groups 2 and 3) or 140 (Group 4). Participants in Part B of the study, in Groups 2 and 3,
      will attend study visits at Days 0, 14, 28, 42, 84, 98, 168, and 273. Participants in Part B
      in Group 4 will attend study visits at Days 0, 14, 28, 42, 56, 70, 140, 154, 224, and 334.
      Participants in Part B of the study will undergo the same study procedures that occurred in
      Part A of the study, with the addition of a cardiac symptoms assessment performed at some
      study visits. Participants in Part B who received the NYVAC vaccine or its placebo prior to
      study vaccinations being stopped will be contacted by phone or e-mail once a year for 5 years
      after they enrolled into the study for follow-up health monitoring.
    

Intervention name(s): DNA-HIV-PT123 vaccine; NYVAC-HIV-PT1 vaccine; NYVAC-HIV-PT4 vaccine; Placebo for DNA-HIV-PT123 vaccine; Placebo for NYVAC-HIV-PT1 vaccine; Placebo for NYVAC-HIV-PT4 vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): DNA-HIV-PT123 4 mg/mL; administered as 1 mL IM in participant's deltoid; NYVAC-HIV-PT1 at greater than or equal to 5x10^6 plaque-forming units (PFU)/ml for a planned maximum dose of 1.2x10^8 PFU/ml; administered as 1 mL IM in participant's deltoid; NYVAC-HIV-PT4 at greater than or equal to 5x10^6 PFU/ml for a planned maximum dose of 1.1x10^7 PFU/ml; administered as 1 mL IM in participant's deltoid; Placebo for DNA-HIV-PT123 administered as 1 mL IM in participant's deltoid; Placebo for NYVAC-HIV-PT1 vaccine administered as 1 mL IM in participant's deltoid; Placebo for NYVAC-HIV-PT4 vaccine administered as 1 mL IM in the participant's deltoid
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention