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A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines ChAdOx1.HTI and MVA.HTI with Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted with MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals

01/01/2021 - 31/12/2023

Type of research: interventional Promoter: European Comission– EAVI2021 Principal Investigators: Beatriz Mothe, Christian Brander

BCN03 tests a novel combined regimen with T- and B-cell immunogens, and the primary endpoints of BCN03 will be safety and tolerability. BCN03 is designed as a pilot study, and the sample size has been chosen that will only allow the detection of large response differences. The BCN03 Phase I study will evaluate the safety, tolerability, immunogenicity, and efficacy of a vaccine regimen that includes a sequence of the T- and B-cell immunogens ChAdOx1.HTI and MVA.HTI and ConM SOSIP.v7 gp140 adjuvanted with MPLA liposomes in virologically-suppressed ART-treated HIV-1 positive individuals. The primary objective of this study is to assess the safety and tolerability of the vaccine components, and secondary objectives include immunogenicity and efficacy of the vaccine components.

  • Design: randomized, double-blind, placebo-controlled
  • Phase: I
  • CEIC Code: 2020-000292-20

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Irsi Caixa

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'La Caixa' Foundation Generalitat de Catalunya - Departament de Salut


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