Evaluating Heterologous-Insert Prime-Boost HIV Vaccine Regimens in HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immune response of an
      adenovirus-based HIV-1 vaccine regimen that includes two vaccines given at different time
      points in HIV-uninfected adults.
    

Detailed description: 
      One approach to developing a preventive HIV vaccine includes the use of a prime-boost vaccine
      strategy. This type of strategy involves two vaccines, given sequentially at different time
      points. The goal is to stimulate different parts of the immune system and enhance the body's
      overall immune response to HIV. In this study, participants will receive two HIV vaccines 3
      months apart. Heterologous-insert prime-boost vaccine regimens, which use the same gene from
      different HIV-1 subtypes, may be more effective than traditional homologous insert
      prime-boost vaccine regimens at eliciting immune responses directed at epitopes that are
      highly prevalent, possibly leading to a more effective immune system response to the vaccine.
      The purpose of this study is to assess the safety and immunogenicity of a heterologous-insert
      prime-boost HIV vaccine regimen that uses inserts from different HIV-1 subtypes and different
      adenovirus vectors.

      This study will enroll healthy, HIV-uninfected people. Participants will be randomly assigned
      to one of five study groups:

        -  Group 1 will receive the recombinant adenovirus serotype 35 (rAd35) Env A vaccine at
           baseline and the recombinant adenovirus serotype 5 (rAd5) Env A vaccine at Month 3.

        -  Group 2 will receive the rAd35 Env A vaccine at baseline and the rAd5 Env B vaccine at
           Month 3.

        -  Group 3 will receive the rAd35 Env A vaccine at baseline and at Month 3.

        -  Group 4 will receive the rAd5 Env A vaccine at baseline and at Month 3.

        -  Group 5 will receive the rAd5 Env A vaccine at baseline and the rAd5 Env B vaccine at
           Month 3.

      All vaccines will be injected into the upper arm. At both vaccination study visits,
      participants will undergo a physical exam, a medical and medication history review, a blood
      and urine collection, and questionnaires. Participants will receive counseling on HIV risk
      reduction and pregnancy prevention. After receiving the vaccine, participants will remain in
      the clinic for at least 30 minutes for observation and monitoring of side effects. For 3 days
      after each vaccination, participants will record their temperature and side effects in a
      symptom log. In addition to the vaccine study visits, other study visits will occur at Week
      2, two weeks after the Month 3 visit, and at Months 4, 6, and 9, at which time various study
      procedures will be repeated.

      Participants will be contacted by study researchers once a year for 5 years for follow-up
      safety monitoring. Safety monitoring will not involve visiting a clinic except if a
      confirmatory HIV test is needed. Questions will assess health and adverse events.

      The primary objective of this study is to assess the safety and tolerability, as well as the
      ability, of a heterologous-insert prime-boost vaccine regimen using env inserts from
      different HIV-1 clades to increase T-cell responses. In addition, this study is evaluating
      the effectiveness of a heterologous-insert prime-boost and vector prime-boost vaccine regimen
      at increasing T-cell responses. The study will also compare the degree of polyfunctionality
      of insert specific T cells after vaccination within heterologous and homologous vector
      vaccine regimens.
    

Intervention name(s): rAd35 Env A; rAd5 Env A; rAd5 Env B
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1 x 10^10 particle units (PU) administered as 1 mL intramuscularly (IM) in deltoid; 1 x 10^10 PU administered as 1 mL IM in deltoid; 1 x 10^10 PU administered as 1 mL IM in deltoid
Other intervention name(s): VRC-HIVADV027-00-VP; VRC-HIVADV038-00-VP; VRC-HIVADV052-00-VP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV Preventive Vaccine