Safety and immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv vaccines in individuals with documented acute/recent HIV-1 infection initiating early antiretroviral treatment | BCN01

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Safety and immunogenicity of ChAdV63.HIVconsv and MVA.HIVconsv vaccines in individuals with documented acute/recent HIV-1 infection initiating early antiretroviral treatment | BCN01

01/09/2012 - 30/09/2015

Type of research: Interventional Promoter: IrsiCaixa AIDS Research Institute Main researchers: Christian Brander Participating entities: Hospital Universitario Germans Trias i Pujol (Fundación Lucha contra el Sida) , Hospital Clínic de Barcelona

Phase I open-label clinical trial of candidate vaccines ChAdV63.HIVconsv and MVA.HIVconsv, developed by University of Oxford researchers as therapeutic vaccines specifically aimed at combating viral diversity by stimulating immune response to the most conserved regions of the virus. Included are 48 individuals with documented acute/recent HIV-1 infection initiating early antiretroviral therapy with TDF/FTC/RAL. The vaccines are administered by two attenuated viral vectors — a chimpanzee adenovirus (ChAd) and a vaccinia virus (MVA) — at 24 and 32 (n=12) or 64 (n=12) weeks from antiretroviral treatment inistiation. An additional 24 individuals who receive early treatment but are not vaccinated are included.  Objectives include studying vaccine administration safety and immune response for the two immunization schedules and evaluating viral reservoir decrease in the context of early treatment initiation and therapeutic vaccination. Patients do not suspend antiretroviral treatment throughout the study. 

  • Design: Open label, Multicentre
  • Sample size: 48
  • CEIC Code: AC-11-027
  • NCT01712425
  • EudraCT: 2011-000846-39

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Irsi Caixa

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