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

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 and Beatriz Mothe ()
Additional contact information
Lucia Bailón: Badalona
José Moltó: Badalona
Adrian Curran: Vall d’Hebron Research Institute (VHIR)
Julen Cadiñanos: Instituto de Salud Carlos III
Juan Carlos Lopez Bernaldo de Quirós: Instituto de Salud Carlos III
Ignacio de Los Santos: Instituto de Salud Carlos III
Juan Ambrosioni: Instituto de Salud Carlos III
Arkaitz Imaz: University of Barcelona
Susana Benet: Badalona
Paula Suanzes: Vall d’Hebron Research Institute (VHIR)
Jordi Navarro: Vall d’Hebron Research Institute (VHIR)
Juan González-García: Instituto de Salud Carlos III
Carmen Busca: Instituto de Salud Carlos III
Leire Pérez-Latorre: Instituto de Investigación Sanitaria Gregorio Marañón
Juan Berenguer: Instituto de Salud Carlos III
Lucio Jesús García-Fraile: Instituto de Salud Carlos III
Gina Mejía-Abril: Hospital Universitario de la Princesa
Jose M. Miró: Instituto de Salud Carlos III
Sofía Scévola: University of Barcelona
Santiago Moreno: IRYCIS
Pere Domingo: Hospital de la Santa Creu i Sant Pau
Yuan Tian: Inc
Michelle Frankot: Inc
Daina Lim: Inc
Yanhui Cai: Inc
Elena Vendrame: Inc
Susan Guo: Inc
Jeffrey J. Wallin: Inc
Romas Geleziunas: Inc
Devi SenGupta: Inc
Yovaninna Alarcón-Soto: Badalona
Isabel Leal: AELIX Therapeutics S.L
Alvaro Aranguen: AELIX Therapeutics S.L
Margarida Garcia-Garcia: AELIX Therapeutics S.L
Ian McGowan: AELIX Therapeutics S.L
Christian Brander: Instituto de Salud Carlos III
Jose Ramón Arribas: Instituto de Salud Carlos III
Beatriz Mothe: Badalona

Nature Communications, 2025, vol. 16, issue 1, 1-16

Abstract: 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.

Date: 2025
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DOI: 10.1038/s41467-025-57284-w

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