Safety of and Immune Response to Prime/Boost Vaccine Regimens in Healthy, HIV-1 Uninfected, Ad5 Seronegative Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigators will examine the safety of and immune responses to two vaccines expressing
      synthetic HIV proteins: NYVAC-B (a poxvirus), and rAd5 (an adenovirus). The study will
      compare responses in participants receiving NYVAC-B first, and rAd5 later, to those who
      receive rAd5 first, and NYVAC-B later. A different dose of rAd5 will be tested in each group.
    

Detailed description: 
      In order to halt the HIV pandemic an effective vaccine must be developed. In this study,
      investigators will examine the safety and immune response to a prime-boost strategy using two
      different vaccine regimens, NYVAC-B and rAd5.

      Eighty participants will be recruited to this study. Participants will be randomly assigned
      to one of four different groups (study arms). Each group will receive both study vaccines and
      placebo but at different times. All NYVAC-B vaccine doses will be the same, but the doses of
      the rAD5 vaccine will differ from group to group. Some participants in each group will
      receive only placebo. Participants will visit the study clinic about 13 times over the course
      of 12 months and be contacted for follow-up for 4 years.

      All study injections will be given in the same upper arm area. There will be a total of four
      injections during the course of the study. After each injection, participants will need to
      stay in the clinic for at least 25 minutes to check for any adverse reactions. Additionally,
      participants will need to monitor their own health on the evening after the injection and for
      the next three evenings, by taking their temperature and making notes of any noticed side
      effects. Tools will be provided to accomplish both of these tasks. During these few days
      following the injection, study investigators will need to maintain contact with participants
      (the participant will specify the best mode of contact).

      Certain clinical procedures will be performed during the course of this study including
      regular HIV testing and counseling, physical exams, collection of blood and urine, pregnancy
      tests if applicable, questions about health and medications, questions about HIV risk and
      sexual behaviors, and any personal problems or benefits participants may have experienced
      from participating in the study.
    

Intervention name(s): NYVAC-B; Placebo; rAd5; rAd5; rAd5
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): New York Vaccinia (NYVAC) vector for HIV-1, delivered intramuscularly by injection at a dose of 1 x 10 ^7 PFU; Sodium Chloride for injection, delivered intramuscularly; Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^10 PFU; Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^9 PFU; Recombinant adenoviral serotype 5 (rAd5) vector vaccine, delivered by injection intramuscularly at a dose of 1 x 10^8 PFU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: HIV; Vaccine; HIV Seronegativity; Preventive Vaccine