{"id":24629,"date":"2025-03-06T09:08:13","date_gmt":"2025-03-06T08:08:13","guid":{"rendered":"https:\/\/lluita.org\/assaig-clinic-de-fase-ii-aelix-003\/"},"modified":"2025-03-06T09:28:12","modified_gmt":"2025-03-06T08:28:12","slug":"assaig-clinic-de-fase-ii-aelix-003","status":"publish","type":"post","link":"https:\/\/lluita.org\/en\/assaig-clinic-de-fase-ii-aelix-003\/","title":{"rendered":"Phase II clinical trial AELIX-003 confirms that the immune response to the HTI therapeutic vaccine helps improve HIV control without treatment"},"content":{"rendered":"<p>A Phase II clinical trial has confirmed that the combination of the HTI therapeutic vaccine\u2014designed at <strong>IrsiCaixa<\/strong>, developed by <strong>AELIX Therapeutics<\/strong> and recently acquired by <a href=\"https:\/\/www.gilead.es\/\"><strong>Gilead Sciences, Inc.<\/strong><\/a>\u2014along with an immune system-modulating drug, is safe and capable of generating an immune response that improves virus control in the absence of antiretroviral treatment in some people. This study, published in <a href=\"https:\/\/www.nature.com\/ncomms\/\">Nature Communications<\/a>, was led by researchers from the <a href=\"http:\/\/www.lluita.org\/en\"><strong>Fight Infections Foundation<\/strong><\/a> at <a href=\"https:\/\/www.hospitalgermanstrias.cat\/web\/guest\"><em>Hospital Germans Trias i Pujol<\/em><\/a>, <a href=\"https:\/\/www.irsicaixa.es\/en\">IrsiCaixa<\/a>, and <a href=\"https:\/\/www.comunidad.madrid\/hospital\/lapaz\/\"><em>Hospital La Paz<\/em><\/a>, with collaboration from multiple hospitals across Spain.<\/p>\n<h3><strong>Enhancing the immune system against HIV <\/strong><\/h3>\n<p>Antiretroviral treatment suppresses the virus to undetectable levels, preventing the progression of infection and eliminating the risk of transmission\u2014an established concept known as <em>undetectable = untransmittable<\/em>. However, finding a cure remains a top priority for the scientific community and for the 39 million people with HIV worldwide.<\/p>\n<p><strong>\u201cThe HTI therapeutic vaccine is designed to retrain the immune system of people with HIV to control the virus without treatment,\u201d<\/strong>\u00a0explains Beatriz Mothe, physician at <em>Hospital Germans Trias i Pujol<\/em>, researcher at IrsiCaixa and the <em>Fundaci\u00f3n Lucha contra las Infecciones<\/em>, and one of the inventors of the vaccine alongside IrsiCaixa principal investigator Christian Brander.<\/p>\n<p>Brander adds: <strong>\u201cWith this study, we aimed to test the vaccine\u2019s efficacy in a new format, reducing the number of vaccine doses and adding the compound Vesatolimod, which modulates the immune system.\u201d<\/strong><\/p>\n<p>In this clinical trial, 50 people with HIV, who had received early treatment after acquiring the virus and had an undetectable viral load, were given the HTI vaccine in combination with the immune-modulating drug Vesatolimod. <strong>\u201cThe results demonstrate that the combination is safe and generates a robust immune response against HIV. Moreover, it confirms what we had observed in previous trials: that the immune response generated contributes to improving HIV control when antiretroviral treatment is temporarily interrupted,\u201d<\/strong> states Luc\u00eda Bail\u00f3n, first author of the study, physician at <em>Hospital Germans Trias i Pujol<\/em>, and researcher at the <em>Fundaci\u00f3n Lucha contra las Infecciones<\/em>.<\/p>\n<p>During the trial, after receiving the vaccine and Vesatolimod combination, participants underwent a supervised interruption of their antiretroviral treatment for up to 24 weeks. The results showed that, although all participants experienced a viral rebound, 33.3% of those who received the vaccine and immune-modulating drug were able to maintain better-controlled viral load levels throughout the treatment interruption period, compared to 23.5% in the group that did not receive the combination.<\/p>\n<h3><strong>A simplified strategy<\/strong><\/h3>\n<p>This trial involved multiple hospitals, reinforcing the validity of the results. Additionally, the study allowed for the evaluation of a simplified vaccination regimen compared to previous research, opening new possibilities for future combination designs. <strong>\u201cThe joint efforts of nine hospitals across Spain were key to evaluating this strategy and strengthening the reliability of the results,\u201d<\/strong> highlights Jos\u00e9 Ram\u00f3n Arribas, physician at Hospital La Paz and study coordinator.<\/p>\n<h3><strong>Immune cells specifically targeting HIV<\/strong><\/h3>\n<p>Analyses have shown that the HTI vaccine is capable of training the immune system so that its cells target specific regions of HIV. <strong>\u201cThis confirms that the vaccine is effectively impacting the immune system of people with HIV, and it is incredibly encouraging to know that we can achieve this,\u201d<\/strong> says co-first author Jos\u00e9 Molt\u00f3, physician at <em>Hospital Germans Trias i Pujol<\/em> and researcher at the <em>Fundaci\u00f3n Lucha contra las Infecciones<\/em>.<\/p>\n<p>These findings represent a significant step forward in the development of therapeutic HIV strategies, paving the way for future clinical trials that combine this vaccine with other approaches in the search for a functional cure for the virus.<\/p>\n<h3><strong>About the study<\/strong><\/h3>\n<p>The study was conducted with the participation of <em><strong>Hospital Germans Trias i Pujol<\/strong>, <strong>Hospital La Paz<\/strong>, <strong>Hospital Universitario Vall d\u2019Hebron<\/strong>, <strong>Hospital General Universitario Gregorio Mara\u00f1\u00f3n<\/strong>, <strong>Hospital Universitario de La Princesa<\/strong>, <strong>Hospital Cl\u00ednic<\/strong>, <strong>Hospital Universitario de Bellvitge<\/strong>, <strong>Hospital Universitario Ram\u00f3n y Cajal<\/strong>,<\/em> and <strong><em>Hospital de la Santa Creu i Sant Pau<\/em><\/strong>.<\/p>\n<p>The research team expresses its deepest gratitude to all the individuals who participated in this study. Without their commitment to advancing scientific research in the pursuit of an HIV cure, these promising results would not have been possible.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>A Phase II clinical trial has confirmed that the combination of the HTI therapeutic vaccine\u2014designed at IrsiCaixa, developed by AELIX Therapeutics and recently acquired by Gilead Sciences, Inc.\u2014along with an immune system-modulating drug, is safe and capable of generating an immune response that improves virus control in the absence of antiretroviral treatment in some people. [&hellip;]<\/p>\n","protected":false},"author":9,"featured_media":24624,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[272],"class_list":["post-24629","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-vih-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.3) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Phase II clinical trial AELIX-003 confirms that the immune response to the HTI therapeutic vaccine helps improve HIV control without treatment - Fundaci\u00f3 Lluita contra les Infeccions<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/lluita.org\/en\/assaig-clinic-de-fase-ii-aelix-003\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Phase II clinical trial AELIX-003 confirms that the immune response to the HTI therapeutic vaccine helps improve HIV control without treatment\" \/>\n<meta property=\"og:description\" content=\"A Phase II clinical trial has confirmed that the combination of the HTI therapeutic vaccine\u2014designed at IrsiCaixa, developed by AELIX Therapeutics and recently acquired by Gilead Sciences, Inc.\u2014along with an immune system-modulating drug, is safe and capable of generating an immune response that improves virus control in the absence of antiretroviral treatment in some people. 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