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
Bailón, Lucía (Institut Germans Trias i Pujol. Fundació Lluita Contra les Infeccions)
Moltó, José (Institut Germans Trias i Pujol. Fundació Lluita Contra les Infeccions)
Curran, Adrian (Hospital Universitari Vall d'Hebron)
Cadiñanos, Julen (Hospital Universitario La Paz (Madrid))
Lopez Bernaldo de Quirós, Juan Carlos (Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM))
de los Santos Gil, Ignacio (Hospital Universitario de la Princesa (Madrid))
Ambrosioni, Juan (Hospital Clínic i Provincial de Barcelona)
Imaz, Arkaitz (Institut d'Investigació Biomèdica de Bellvitge)
Benet, Susana (Institut Germans Trias i Pujol. Fundació Lluita Contra les Infeccions)
Suanzes, Paula (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Navarro, Jordi (Hospital Universitari Vall d'Hebron. Institut de Recerca)
González-García, Juan (Hospital Universitario La Paz (Madrid))
Busca, Carmen (Hospital Universitario La Paz (Madrid))
Pérez Latorre, Leire (Hospital General Universitario Gregorio Marañón. Instituto de Investigación Sanitaria Gregorio Marañón (IiSGM))
Berenguer, Juan (Hospital General Universitario Gregorio Marañón)
García-Fraile Fraile, Lucio (Hospital Universitario de la Princesa (Madrid))
Mejía-Abril, Gina (Hospital Universitario de la Princesa (Madrid))
Miró, Jose M. (Hospital Clínic i Provincial de Barcelona)
Scévola, Sofia (Institut d'Investigació Biomèdica de Bellvitge)
Moreno, Santiago (Hospital Universitario Ramón y Cajal (Madrid))
Domingo, Pere (Institut de Recerca Sant Pau)
Tian, Yuan (Gilead Sciences, Inc, Foster City, CA, USA)
Frankot, Michelle (ClinData Insight, Inc, Moraga, CA, USA)
Lim, Daina (Gilead Sciences, Inc, Foster City, CA, USA)
Cai, Yanhui (Gilead Sciences, Inc, Foster City, CA, USA)
Vendrame, Elena (Gilead Sciences, Inc, Foster City, CA, USA)
Guo, Susan (Gilead Sciences, Inc, Foster City, CA, USA)
Wallin, Jeffrey J. (Gilead Sciences, Inc, Foster City, CA, USA)
Geleziunas, Roman (Gilead Sciences, Inc, Foster City, CA, USA)
SenGupta, Devi (Gilead Sciences, Inc, Foster City, CA, USA)
Alarcón-Soto, Yovaninna (Institut Germans Trias i Pujol. Fundació Lluita Contra les Infeccions)
Leal, Isabel (AELIX Therapeutics S.L)
Aranguen, Alvaro (AELIX Therapeutics S.L)
Garcia-Garcia, Margarida (AELIX Therapeutics S.L)
McGowan, Ian (AELIX Therapeutics S.L)
Brander, Christian (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)
Arribas, José Ramón (Hospital Universitario La Paz (Madrid))
Mothe, Beatriz (Institut Germans Trias i Pujol. Institut de Recerca de la Sida IrsiCaixa)

Date:	2025
Abstract:	520 3_.
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.
Grants:	Instituto de Salud Carlos III CM20/00097
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	Nature communications, Vol. 16, Núm. 1 (March 2025) , ISSN 2041-1723

DOI: 10.1038/s41467-025-57284-w
PMID: 40038256

16 p, 3.0 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles