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Safety, immunogenicity and effect on viral rebound of HTI vaccines in early treated HIV-1 infection: a randomized, placebo-controlled phase 1 trial

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

DOI

  • Lucia Bailón, Autonomous University of Barcelona
    • ,
  • Anuska Llano, Autonomous University of Barcelona
    • ,
  • Samandhy Cedeño, Autonomous University of Barcelona
    • ,
  • Tuixent Escribà, Autonomous University of Barcelona
    • ,
  • Miriam Rosás-Umbert
  • Mariona Parera, Autonomous University of Barcelona
    • ,
  • Maria Casadellà, Autonomous University of Barcelona
    • ,
  • Miriam Lopez, Autonomous University of Barcelona
    • ,
  • Francisco Pérez, Autonomous University of Barcelona
    • ,
  • Bruna Oriol-Tordera, Autonomous University of Barcelona
    • ,
  • Marta Ruiz-Riol, Autonomous University of Barcelona, Carlos III Health Institute (ISCIII)
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  • Josep Coll, Autonomous University of Barcelona, Carlos III Health Institute (ISCIII), BCN Checkpoint
    • ,
  • Felix Perez, BCN Checkpoint
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  • Àngel Rivero, BCN Checkpoint
    • ,
  • Anne R. Leselbaum, BCN Checkpoint
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  • Ian McGowan, AELIX Therapeutics, University of Pittsburgh
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  • Devi Sengupta, Gilead Sciences, Inc.
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  • Edmund G. Wee, University of Oxford
    • ,
  • Tomáš Hanke, University of Oxford, Kumamoto University
    • ,
  • Roger Paredes, Autonomous University of Barcelona, Carlos III Health Institute (ISCIII), The University of Vic - Central University of Catalonia, Germans Trias I Pujol Research Institte
    • ,
  • Yovaninna Alarcón-Soto, Autonomous University of Barcelona, Polytechnic University of Catalonia
    • ,
  • Bonaventura Clotet, Autonomous University of Barcelona, Carlos III Health Institute (ISCIII), The University of Vic - Central University of Catalonia
    • ,
  • Marc Noguera-Julian, Autonomous University of Barcelona, Carlos III Health Institute (ISCIII), The University of Vic - Central University of Catalonia
    • ,
  • Christian Brander, Autonomous University of Barcelona, Carlos III Health Institute (ISCIII), AELIX Therapeutics, The University of Vic - Central University of Catalonia, ICREA
    • ,
  • the AELIX002 Study Group

HIVACAT T-cell immunogen (HTI) is a novel human immunodeficiency virus (HIV) vaccine immunogen designed to elicit cellular immune responses to HIV targets associated with viral control in humans. The AELIX-002 trial was a randomized, placebo-controlled trial to evaluate as a primary objective the safety of a combination of DNA.HTI (D), MVA.HTI (M) and ChAdOx1.HTI (C) vaccines in 45 early-antiretroviral (ART)-treated individuals (44 men, 1 woman; NCT03204617). Secondary objectives included T-cell immunogenicity, the effect on viral rebound and the safety of an antiretroviral treatment interruption (ATI). Adverse events were mostly mild and transient. No related serious adverse events were observed. We show here that HTI vaccines were able to induce strong, polyfunctional and broad CD4 and CD8 T-cell responses. All participants experienced detectable viral rebound during ATI, and resumed ART when plasma HIV-1 viral load reached either >100,000 copies ml−1, >10,000 copies ml−1 for eight consecutive weeks, or after 24 weeks of ATI. In post-hoc analyses, HTI vaccines were associated with a prolonged time off ART in vaccinees without beneficial HLA (human leukocyte antigen) class I alleles. Plasma viral load at the end of ATI and time off ART positively correlated with vaccine-induced HTI-specific T-cell responses at ART cessation. Despite limited efficacy of the vaccines in preventing viral rebound, their ability to elicit robust T-cell responses towards HTI may be beneficial in combination cure strategies, which are currently being tested in clinical trials.

OriginalsprogEngelsk
TidsskriftNature Medicine
Vol/bind28
Nummer12
Sider (fra-til)2611-2621
Antal sider11
ISSN1078-8956
DOI
StatusUdgivet - dec. 2022

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