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

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

Abstract 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, randomi...

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Main Authors: 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, On behalf of the AELIX-003 Study Group
Format: Article
Language:English
Published: Nature Portfolio 2025-03-01
Series:Nature Communications
Online Access:https://doi.org/10.1038/s41467-025-57284-w
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Summary:Abstract 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.
ISSN:2041-1723

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