Bailón, LuciaMoltó, JoséCurran, AdrianCadiñanos Loidi, JulenLópez Bernaldo de Quirós, Juan CarlosSantos, Ignacio de losAmbrosioni, JuanImaz, ArkaitzBenet, SusanaSuanzes, PaulaNavarro, JordiGonzález García, JuanBusca, CarmenPérez Latorre, LeireBerenguer, JuanGarcía Fraile Fraile, Lucio JesúsMejía Abril, GinaMiró Meda, José M. (José María), 1956-Scévola, SofíaMoreno Guillén, SantiagoDomingo, Pere (Domingo Pedrol)Tian, YuanFrankot, MichelleLim, DainaCai, YanhuiVendrame, ElenaGuo, SusanWallin, Jeffrey J.Geleziunas, RomasSenGupta, DeviAlarcón Soto, YovaninnaLeal Cortijo, IsabelAranguen Ibáñez, AlvaroGarcía García, MargaridaMcgowan, IanBrander, ChristianArribas, Jose RamónMothe, BeatrizThe Aelix-003 Study Group2025-06-042025-06-042025-03-042041-1723https://hdl.handle.net/2445/221361Building 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.16 p.application/pdfengcc-by-nc-nd (c) Bailón et al., 2025http://creativecommons.org/licenses/by-nc-nd/3.0/es/AntiretroviralsVIH (Virus)Assaigs clínicsAntiretroviral agentsHIV (Viruses)Clinical trialsinfo:eu-repo/semantics/article2025-05-20info:eu-repo/semantics/openAccess40038256