Evaluating the Safety and Immune Response of a Prime-Boost HIV Vaccine Regimen in Healthy, HIV-Uninfected, Vaccinia-Naive Adults
Condition: HIV Infections
MeSH terms: Vaccinia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety and immune responses of a prime-boost regimen of two HIV
      vaccines- a DNA vaccine followed by a modified vaccinia Ankara (MVA) vaccine- in healthy,
      HIV-uninfected, vaccinia-naive adults.
    

Detailed description: 
      Although multiple candidate HIV vaccines are being studied, there is not yet an effective
      preventive HIV vaccine. This study will test the safety and immune responses of prime-boost
      regimens of two HIV vaccines: two injections of GEO-D03 DNA priming vaccine followed by
      either two or three boosting injections of MVA/HIV62B (MVA62B) vaccine.

      This study will enroll 48 healthy, HIV-1-uninfected, vaccinia-naive adults into 1 of 3
      groups. Participants within each group will be randomly assigned to receive either the study
      vaccine regimen (40 total participants) or placebo vaccine regimen (8 total participants).

      The total study duration will be approximately 45 months. Participants in Group 1 will attend
      clinic visits for 14 months followed by annual health contacts, for a total of 3 years after
      initial study injection. Participants in Group 2 will attend clinic visits for 22 months
      followed by annual health contacts, for a total of 3 years after initial study injection.
      Participants in Group 3 will attend clinic visits for 20 months followed by annual health
      contacts, for a total of 3 years after initial study injection. Participants in Group 1 will
      have 17 study visits, participants in Group 2 will have 23 visits, and participants in Group
      3 will have 21 visits.

      At the screening visit, participants will give a medical history and undergo a complete
      physical exam, electrocardiogram (ECG), urine collection, blood collection, interview, HIV
      test, and pregnancy test (for participants who were born female). Participants will receive
      an intramuscular (IM) vaccination (study vaccine or placebo) into the deltoid on the schedule
      assigned to their group. The vaccination schedule is as follows: Group 1 participants will
      receive an injection on Days 0, 56, 112, 168, and 224; Group 2 participants will receive an
      injection on Days 0, 56, 112, 168, and 303; Group 3 participants will receive an injection on
      Days 0, 56, 112, and 224. On vaccination visits, participants will also undergo an
      abbreviated physical exam, a pregnancy test (for participants who were born female),
      risk-reduction counseling, and blood collection. Immediately following vaccination,
      participants will remain in the clinic for observation for 30 minutes; participants will be
      given a post-vaccination symptom log and instructed on how to complete it. Follow-up visits
      will consist of a brief physical exam, blood collection, and interview; some follow-up visits
      may also consist of a urine collection, HIV test, or ECG.

      The last clinic visit will be at Day 425 for participants in Group 1, Day 667 for
      participants in Group 2, and Day 607 for participants in Group 3; after this visit,
      participants will be contacted for annual health follow-up consisting of confirming vital
      status, collecting safety information, and reporting a new HIV diagnosis or a pregnancy. A
      clinic visit will only be required if HIV confirmatory testing is necessary.
    

Intervention name(s): GEO-D03 DNA vaccine; MVA/HIV62B (MVA62B) vaccine; Placebo for GEO-D03 DNA; Placebo for MVA62B:
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Either a 0.3-mg (Group 1: study vaccine) or 3-mg dose (Groups 2 and 3: study vaccine) administered as a 1-mL IM injection into the deltoid; 1 x 10^8-TCID50 dose of MVA62B vaccine, administered as a 1-mL IM injection into the deltoid; Administered as a 1-mL IM injection into the deltoid; Administered as a 1-mL IM injection into the deltoid
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention