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<p>Building on results from the AELIX-002 trial with HIVACAT T-cell immunogen (HTI)-based vaccines, the AELIX-003 (NCT04364035) trial tested the safety of the combination of ChAdOx1.HTI (C) and MVA.HTI (M), with the TLR7 agonist vesatolimod (VES), in a double-blind, placebo-controlled, randomized clinical trial in 50 virally suppressed early-treated men with HIV-1 infection. Secondary objectives included immunogenicity and effects on viral rebound kinetics during a 24-week antiretroviral treatment interruption (ATI). The most common treatment-related adverse events were mild-to-moderate injection-site pain, influenza-like illness, headache, and fatigue. Strong, broad, and HTI-focused T-cell responses were induced by vaccination. All participants experienced viral rebound in ATI; 33.3% and 23.5% (<i>P</i> = 0.4494) of CCMM + VES and placebo recipients, respectively, remained off antiretroviral therapy for 24 weeks. Post&#xa0;hoc analysis confirmed a correlation between levels of HTI-specific T cells and prolonged time off antiretroviral therapy. The combination of HTI vaccines and VES was safe and elicited robust T-cell responses.</p>

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Safety, immunogenicity and effect on viral rebound of HTI vaccines combined with a TLR7 agonist in early-treated HIV-1 infection: a randomized, placebo-controlled phase 2a trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月4日

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  • Lucia Bailón,
  • José Moltó,
  • Adrian Curran,
  • Julen Cadiñanos,
  • Juan Carlos Lopez Bernaldo de Quirós,
  • Ignacio de Los Santos,
  • Juan Ambrosioni,
  • Arkaitz Imaz,
  • Susana Benet,
  • Paula Suanzes,
  • Jordi Navarro,
  • Juan González-García,
  • Carmen Busca,
  • Leire Pérez-Latorre,
  • Juan Berenguer,
  • Lucio Jesús García-Fraile,
  • Gina Mejía-Abril,
  • Jose M. Miró,
  • Sofía Scévola,
  • Santiago Moreno,
  • Pere Domingo,
  • Yuan Tian,
  • Michelle Frankot,
  • Daina Lim,
  • Yanhui Cai,
  • Elena Vendrame,
  • Susan Guo,
  • Jeffrey J. Wallin,
  • Romas Geleziunas,
  • Devi SenGupta,
  • Yovaninna Alarcón-Soto,
  • Isabel Leal,
  • Alvaro Aranguen,
  • Margarida Garcia-Garcia,
  • Ian McGowan,
  • Christian Brander,
  • Jose Ramón Arribas,
  • Beatriz Mothe,
  • Ignacio de Los Santos,
  • Patricia Cobarsí,
  • Cristina Martinez,
  • Aroa Nieto,
  • Francisco Perez,
  • Jordi Puig,
  • Samandhy Cedeño,
  • Bonaventura Clotet,
  • Eulalia Grau,
  • Anuska Llano,
  • Roger Paredes,
  • Jose Luís Cabero,
  • Jordi Naval,
  • Vicenç Falcó,
  • Bibiana Planas,
  • Joaquin Burgos,
  • María José Buzón,
  • Meritxell Genescà,
  • Judith Grau,
  • Alberto Borobia,
  • Victor Hontañon,
  • Javier Queiruga,
  • Rafael Mican,
  • Enrique Seco,
  • Cristina Diez,
  • Paloma Gijón,
  • Margarita Ramirez,
  • Samuel Martín-Vílchez,
  • Alejandro de Miguel-Cáceres,
  • José María Serra,
  • Tamara De la Torre-Muñoz,
  • Eva Ariza,
  • Anna Ferrer,
  • Benito Garcia,
  • Sandra Morenilla,
  • Jordi Niubó,
  • Camila Piatti,
  • Irene Soriano,
  • Daniel Vázquez

摘要

Building on results from the AELIX-002 trial with HIVACAT T-cell immunogen (HTI)-based vaccines, the AELIX-003 (NCT04364035) trial tested the safety of the combination of ChAdOx1.HTI (C) and MVA.HTI (M), with the TLR7 agonist vesatolimod (VES), in a double-blind, placebo-controlled, randomized clinical trial in 50 virally suppressed early-treated men with HIV-1 infection. Secondary objectives included immunogenicity and effects on viral rebound kinetics during a 24-week antiretroviral treatment interruption (ATI). The most common treatment-related adverse events were mild-to-moderate injection-site pain, influenza-like illness, headache, and fatigue. Strong, broad, and HTI-focused T-cell responses were induced by vaccination. All participants experienced viral rebound in ATI; 33.3% and 23.5% (P = 0.4494) of CCMM + VES and placebo recipients, respectively, remained off antiretroviral therapy for 24 weeks. Post hoc analysis confirmed a correlation between levels of HTI-specific T cells and prolonged time off antiretroviral therapy. The combination of HTI vaccines and VES was safe and elicited robust T-cell responses.