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This pooled analysis combines two randomized, placebo-controlled trials (AELIX-002 and AELIX-003) evaluating HTI immunogen-based vaccines alone or with vesatolimod, analyzing 88 participants. Logistic regression and ROC analyses link HTI-specific T-cell magnitude with slower, delayed viral rebound. An HTI-specific threshold of 835 spot-forming cells/10^6 PBMCs predicts staying off ART for over 12 weeks and can support futility criteria and participant selection in future HIV cure trials.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/predictors-of-virological-outcomes-after-analytical-interruption-of-antiretroviral-therapy-and-hti-vaccination-abstract/455669/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/predictors-of-virological-outcomes-after-analytical-interruption-of-antiretroviral-therapy-and-hti-vaccination-abstract/455669.png","ImageObject",300,407,{"name":92,"@type":93},"Riley","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-06","2026-09-30",true,{"@type":102,"interactionType":103,"userInteractionCount":14},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What is the goal of the AELIX-002 and AELIX-003 trials combined in this analysis?","Question",{"text":112,"@type":113},"To identify predictors of virological outcomes during a 24-week analytical treatment interruption (ATI), based on immune responses elicited by HTI vaccines alone or with vesatolimod.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How was the relationship between immune responses and ATI outcomes evaluated?",{"text":117,"@type":113},"By performing a pooled analysis of both RCTs and using logistic regression and receiver operating characteristic (ROC) analyses on clinical, immunogenicity, and viral data.",{"name":119,"@type":110,"acceptedAnswer":120},"What immune threshold predicts delayed and slower viral rebound during ATI?",{"text":121,"@type":113},"An HTI-specific threshold of 835 spot-forming cells per 10^6 peripheral blood mononuclear cells (PBMCs).","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},455669,1791306892,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":14,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":34,"language":139,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":140,"faqs":141,"seo_title":142,"seo_description":67,"update_tm":143,"read_time":144},1374391975076,"https://ap-avatar.wpscdn.com/avatar/14000253ca4ec9f6853?x-image-process=image/resize,m_fixed,w_180,h_180&k=1783305029341752051","A Nature Portfolio journal  \n[https://doi.org/10.1038/s43856-025-01266-y](https://doi.org/10.1038/s43856-025-01266-y)  \ncacy of  \nPublished guidelines describe safe conduct of  \n\n| Predictors of virological outcomes after analytical interruption of antiretroviral therapy and HTI vaccination in early treated people with HIV-1. \u003Cbr> Check for updates |  |  |\n| --- | --- | --- |\n| Lucia Bailón  1,2,17, Yovaninna Alarcón-Soto  1,17, José R. Arribas3,4,5, Adrian Curran6, Anuska Llano7, Samandhy Cedeño 8, Roger Paredes 1,3,8,9,10,11, Elena Vendrame 12, Devi SenGupta12,\u003Cbr>Jeffrey J. Wallin12, Romas Geleziunas12, Marie P. Malice13, Ian McGowan14,15,\u003Cbr>Christian Brander 3,8,10,14,16,17 , José Moltó1,3,17  & Beatriz Mothe  1,3,8,10,17 |  |  |\n| Abstract Plain language summary |  |  |\n| Background Randomized, placebo-controlled clinical trials (RCTs) that include analytical treatment interruptions (ATI) are conducted to test the efficacy of HIV cure strategies. Two independent RCTs, AELIX-002 and AELIX-003, evaluated the HTI immunogen-based vaccines alone or combined with the TLR7 agonist vesatolimod in early-treated people with HIV (etPWH). These studies individually demonstrated that higher levels of vaccine-induced HTI-specific T-cell responses were associated with extended time off antiretroviral therapy (ART) during a 24-week ATI.\u003Cbr>Methods We conducted a pooled analysis of both RCTs including the individual data of a total of 88 participants. The association between clinical, immunogenicity and viral data andrebound outcomes during the ATI was evaluated using logistic regression and receiver operating characteristic (ROC) analyses.\u003Cbr>Results We identify an HTI-specificthreshold of835spot-forming cells/106 peripheral blood mononuclear cells as a predictor of delayed and slower viral rebound during ATI. This threshold distinguishes participants who remain offART for>12weeks, with58%sensitivity, 85% specificity, 75% positive and 73% negative predictive value.\u003Cbr>Conclusions Thesefindings confirm that HTI-specificT-cell magnitude atATI initiation is the strongest predictor ofATI outcomes observed inAELIX002/003 studies and that a threshold of vaccine-induced HTI-specific T-cell responses can be used as futility criteria before ATI and/or guide participant selection in future HTI-based HIV cure trials aimed at achieving therapy-free remission. |  | People with HIV have a weakened immune system and so cannot respond well to other infections. Current treatment usually requires people to take antiretroviral therapy (ART) for life. Vaccination could potentially help the body’s immune system control the virus without daily treatment. To test how well vaccinations work, people with HIV were asked stop taking ART. In this study, we combined the results from two clinical trials that tested different combinations of HIV vaccines that were given alone or with another drug that stimulated the immune system. We found that participants who developed higher levels of immune responses to the vaccines were more likely to keep the virus under control for longer periods of time after stopping ART. Importantly, we found an amount of vaccine response that could predict which participants could remain withoutART for at least 12 weeks. This information could be useful in future HIV treatment studies to recommend which study participants can or cannot stop ART, which is helpful to reduce the risks associated to ART interruption. |\n| Over the past decade, interest has grown in developing immune strategies to induce durable HIV-1 control without antiretroviral therapy (ART). However, no validated biomarkers currently predict virological control after ART cessation, leaving analytical treatment interruptions (ATI) and | inclusion of placebo groups as the only reliable tools to assess the effi therapeutic interventions1,2.\u003Cbr>ATI in clinical trials, ensuring that participants can re-suppress HIV-1 plasma viral load (pVL) upon resuming ART with no/minimal increases in ","cbCaieGegXn7ohSQ","https://ap.wps.com/l/cbCaieGegXn7ohSQ","pdf",760405,"English","# Abstract\n## Background\n## Methods\n## Results\n## Conclusions","[{\"question\":\"What is the goal of the AELIX-002 and AELIX-003 trials combined in this analysis?\",\"answer\":\"To identify predictors of virological outcomes during a 24-week analytical treatment interruption (ATI), based on immune responses elicited by HTI vaccines alone or with vesatolimod.\"},{\"question\":\"How was the relationship between immune responses and ATI outcomes evaluated?\",\"answer\":\"By performing a pooled analysis of both RCTs and using logistic regression and receiver operating characteristic (ROC) analyses on clinical, immunogenicity, and viral data.\"},{\"question\":\"What immune threshold predicts delayed and slower viral rebound during ATI?\",\"answer\":\"An HTI-specific threshold of 835 spot-forming cells per 10^6 peripheral blood mononuclear cells (PBMCs).\"}]","Predictors of virological outcomes after analytical interruption of antiretroviral therapy and HTI vaccination - Abstract | PDF",1790743818,18]