Evaluating the Safety and Priming Response of an HIV Vaccine Regimen in Healthy, HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety of and the body's immune response to experimental HIV
      vaccine regimens using different vaccine priming combination, and boosting with the vaccines
      NYVAC and AIDSVAX® B/E.
    

Detailed description: 
      Although multiple candidate HIV vaccines are being studied, there is not yet an effective
      preventive HIV vaccine. This study will test 4 experimental HIV vaccine regimens, each
      boosting with the NYVAC + AIDSVAX® B/E vaccine combination. Priming will be done with NYVAC
      or DNA vaccines, alone or in combination with AIDSVAX® B/E.

      The study will enroll 96 healthy participants, ages 18 - 50 years. Participants will be
      randomly assigned to 1 of 4 groups. In each group, there will be 20 participants who receive
      the vaccine regimen and 4 receiving only placebo. Injections will take place at months 0, 1,
      3, and 6.

      All groups will enroll simultaneously. Enrollment will be restricted to a maximum of 2
      participants per day, with no more than (1) participant in group 1 or 2 and (1) participant
      in group 3 or 4 until 20 participants have been enrolled with 5 in each group (4 vaccine
      recipients and 1 placebo recipient in each group). The HVTN 096 PSRT will review the safety
      and immune response data for the first 168 hours postvaccination on each of these
      participants, and will determine whether it is safe to proceed with full enrollment.

      Total study duration will be 60 months: 18 months of clinic visits followed by annual health
      contacts to a total of 5 years after initial study injection. At the screening visit,
      participants will give a medical history and undergo a complete physical exam, cardiac
      symptom assessment (including ECG), urine collection, blood collection, interview, HIV test,
      and pregnancy test (for participants who were born female). On Days 0, 28, 84, and 168
      participants will receive intramuscular (IM) vaccination (vaccine or placebo) into the right
      and left deltoids. On vaccination visits, participants will also undergo an abbreviated
      physical exam, cardiac symptom assessment, Social impact assessment, 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.
      Optional mucosal secretion collection, if the participant agrees, will be done on days 0,
      168, and 364.

      The last clinic visit will be at Day 545; 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): DNA-HIV-PT123; NYVAC-HIV-PT1; NYVAC-HIV-PT4; AIDSVAX® B/E; Placebo for DNA/NYVAC; Placebo for AIDSVAX(R) B/E
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 4 mg of DNA encoding clade C ZM96 Gag and gp140, CN54 Pol-Nef, administered intramuscularly (IM); (along with NYVAC-HIV-PT4); ≥ 5x106 PFU encoding clade C ZM96 gp140 and ZM96 Gag and CN54 Pol-Nef, administered IM; (along with NYVAC-HIV-PT1); ≥ 5x106 PFU encoding clade C ZM96 gp140 and ZM96 Gag and CN54 Pol-Nef, administered IM; 300mcg of subtype B (MN) HIV gp120 glycoprotein and 300mcg of subtype E (A244) HIV gp120 glycoprotein absorbed onto 600mcg of aluminum hydroxide gel adjuvant, administered IM.; Sodium Chloride for injection, 0.9% administered IM; 600 mcg of aluminum hydroxide adjuvant, administered IM
Other intervention name(s): DNA Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention