{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T12:09:37Z","timestamp":1790251777111,"version":"4.1.0"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"9","license":[{"start":{"date-parts":[[2026,9,21]],"date-time":"2026-09-21T00:00:00Z","timestamp":1789948800000},"content-version":"vor","delay-in-days":20,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006507","name":"Funda\u00e7\u00e3o Oswaldo Cruz","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100006507","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Tuberculosis (TB) remains a leading cause of morbidity and mortality among people living with HIV (PLHIV). Although M72\/AS01 demonstrated efficacy against active TB in HIV-negative adults, its safety in PLHIV is uncertain. As AS01 induces strong innate immune activation, evaluating tolerability in immunocompromised individuals is essential. We assessed the safety of M72\/AS01 in PLHIV receiving antiretroviral therapy (ART).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We systematically searched MEDLINE, Embase, CENTRAL, and Web of Science for randomized controlled trials (RCTs) of PLHIV receiving M72\/AS01 or placebo (last search 28 September 2025). Risk of bias was assessed using RoB 2 and certainty of evidence with GRADE. The protocol was registered in PROSPERO (CRD420251180412). Primary outcomes were risks of solicited local and systemic adverse events (AEs), any grade and grade 3, within 7 days postvaccination. Pooled risk ratios (RRs) were estimated using random-effects inverse-variance models.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Three RCTs (510 participants; M72\/AS01 = 263, placebo = 247) were included. M72\/AS01 increased risk of pain (RR 3.24, 95% CI 1.87\u20135.62), swelling (RR 4.64, 95% CI 2.93\u20137.34), headache (RR 1.83, 95% CI 1.52\u20132.20), myalgia (RR 2.36, 95% CI 1.80\u20133.10), and fever (RR 1.95, 95% CI 1.45\u20132.63). Events were predominantly mild-to-moderate and self-limited. No meaningful difference was observed in unsolicited AEs, and no vaccine-related serious AEs (SAEs) were reported. Certainty ranged from high (common events) to low (rare grade 3 AEs) due to imprecision.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>M72\/AS01 demonstrated a favorable safety profile in immunologically stable, virologically suppressed adults living with HIV on ART, with no increase in SAE or unsolicited AEs. These findings support its safe use and justify future studies evaluating its efficacy for TB prevention in this population.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ofid\/ofag578","type":"journal-article","created":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T13:53:49Z","timestamp":1788616429000},"source":"Crossref","is-referenced-by-count":0,"title":["Safety of the M72\/AS01 Tuberculosis Vaccine in People Living With HIV: A Systematic Review and Meta-Analysis"],"prefix":"10.1093","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-4274-8008","authenticated-orcid":false,"given":"Pedro Sandes","family":"Pereira","sequence":"first","affiliation":[{"name":"Curso de Medicina, Escola Bahiana de Medicina e Sa\u00fade P\u00fablica , Salvador ,","place":["Brazil"]},{"name":"MONSTER Institute for Education, Care, Research, and Technological Development in Health, Institute for Research in Priority Populations (IRPP) , Salvador ,","place":["Brazil"]},{"name":"Laboratory of Clinical and Translational Research, Gon\u00e7alo Moniz Institute, Oswaldo Cruz Foundation , Salvador ,","place":["Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judson Carlos Santos","family":"Neri Junior","sequence":"additional","affiliation":[{"name":"Curso de Medicina, Escola Bahiana de Medicina e Sa\u00fade P\u00fablica , Salvador ,","place":["Brazil"]},{"name":"MONSTER Institute for Education, Care, Research, and Technological Development in Health, Institute for Research in Priority Populations (IRPP) , Salvador ,","place":["Brazil"]},{"name":"Laboratory of Clinical and Translational Research, Gon\u00e7alo Moniz Institute, Oswaldo Cruz Foundation , Salvador ,","place":["Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deivide","family":"Oliveira-De-Souza","sequence":"additional","affiliation":[{"name":"MONSTER Institute for Education, Care, Research, and Technological Development in Health, Institute for Research in Priority Populations (IRPP) , Salvador ,","place":["Brazil"]},{"name":"Laboratory of Clinical and Translational Research, Gon\u00e7alo Moniz Institute, Oswaldo Cruz Foundation , Salvador ,","place":["Brazil"]},{"name":"Programa de P\u00f3s-Gradua\u00e7\u00e3o em Medicina e Sa\u00fade Humana, Escola Bahiana de Medicina e Sa\u00fade P\u00fablica , Salvador ,","place":["Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6833-3811","authenticated-orcid":false,"given":"Bruno B","family":"Andrade","sequence":"additional","affiliation":[{"name":"Curso de Medicina, Escola Bahiana de Medicina e Sa\u00fade P\u00fablica , Salvador ,","place":["Brazil"]},{"name":"MONSTER Institute for Education, Care, Research, and Technological Development in Health, Institute for Research in Priority Populations (IRPP) , Salvador ,","place":["Brazil"]},{"name":"Laboratory of Clinical and Translational Research, Gon\u00e7alo Moniz Institute, Oswaldo Cruz Foundation , Salvador ,","place":["Brazil"]},{"name":"Programa de P\u00f3s-Gradua\u00e7\u00e3o em Medicina e Sa\u00fade Humana, Escola Bahiana de Medicina e Sa\u00fade P\u00fablica , Salvador ,","place":["Brazil"]},{"name":"Brazilian Tuberculosis Research Network (REDE-TB) , Rio de Janeiro, RJ ,","place":["Brazil"]},{"name":"Division of Infectious Diseases, Johns Hopkins University School of Medicine , Baltimore, Maryland ,","place":["USA"]},{"name":"Department of International Health, Johns Hopkins University Bloomberg School of Public Health , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beatriz","family":"Barreto-Duarte","sequence":"additional","affiliation":[{"name":"MONSTER Institute for Education, Care, Research, and Technological Development in Health, Institute for Research in Priority Populations (IRPP) , Salvador ,","place":["Brazil"]},{"name":"Laboratory of Clinical and Translational Research, Gon\u00e7alo Moniz Institute, Oswaldo Cruz Foundation , Salvador ,","place":["Brazil"]},{"name":"Brazilian Tuberculosis Research Network (REDE-TB) , Rio de Janeiro, RJ ,","place":["Brazil"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,9,21]]},"reference":[{"key":"2026092407515311300_ofag578-B1","author":"World Health Organization"},{"key":"2026092407515311300_ofag578-B2","author":"Global tuberculosis report 2023"},{"key":"2026092407515311300_ofag578-B3","author":"World Health Organization"},{"key":"2026092407515311300_ofag578-B4","author":"World Health Organization"},{"key":"2026092407515311300_ofag578-B5","author":"World Health Organization"},{"key":"2026092407515311300_ofag578-B6","doi-asserted-by":"crossref","first-page":"571","DOI":"10.5588\/ijtld.10.0483","article-title":"Antiretroviral therapy and the control of HIV-associated tuberculosis. 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