{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T06:06:06Z","timestamp":1789538766802,"version":"build-2803163510"},"reference-count":28,"publisher":"International Union Against Tuberculosis and Lung Disease","issue":"9","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJTLD Open"],"accepted":{"date-parts":[[2026,5,11]]},"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:title>SUMMARY<\/jats:title>\n                  <jats:sec>\n                    <jats:title>BACKGROUND<\/jats:title>\n                    <jats:p>Historically, pregnant and lactating women (PLW) have been excluded from clinical trials for TB, thereby denying them access to novel treatment and prevention regimens. We aimed to develop an inventory of TB therapeutic and vaccine trials and determine the barriers and facilitators to the inclusion of PLW in TB clinical trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>METHODS<\/jats:title>\n                    <jats:p>Using a mixed-methods approach, we conducted: a review of recent, current, and planned trials\u2019 inclusion and exclusion practices, and in-depth interviews with trialists and sponsors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>Of 40 TB therapeutic trials, 7\/40 (18%) included PLW; 3\/40 (8%) excluded PLW at enrolment but allowed women to remain on study treatment if they became pregnant. None of 12 vaccine trials included PLW but 6\/12 (50%) included PLW in safety and\/or immunogenicity assessments during study follow-up. Eighteen participants completed in-depth interviews. We identified four broad themes: shifting the narrative, differentiated risks, perceived concerns of PLW, and strategies for inclusion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>With limited inclusion of PLW in TB therapeutic trials and no inclusion in vaccine trials at the time of enrolment, there was consensus that clear guidance is required for trialists, funders, and sponsors on strategies for inclusion of PLW, thus ensuring equitable access to novel TB prevention and treatment regimens.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.5588\/ijtldopen.26.0107","type":"journal-article","created":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T05:49:38Z","timestamp":1789537778000},"page":"574-579","source":"Crossref","is-referenced-by-count":0,"title":["Inclusion of pregnant and lactating women in TB treatment and vaccine trials"],"prefix":"10.5588","volume":"3","author":[{"given":"S-A.","family":"Meehan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.C.","family":"Hesseling","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Viljoen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.M.","family":"Cranmer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Verkuijl","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"K.","family":"Viney","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Maktabi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Isaacs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Y.","family":"Hirsch-Moverman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"3554","published-online":{"date-parts":[[2026,9,1]]},"reference":[{"issue":"3","key":"2026091522493313000_3.9.574.1","doi-asserted-by":"crossref","first-page":"20200320","DOI":"10.1183\/13993003.01886-2019","article-title":"Increased risk of active tuberculosis during pregnancy and postpartum: a register-based cohort study in Sweden","volume":"55","author":"Jonsson","year":"2020","journal-title":"Eur Respir J"},{"key":"2026091522493313000_3.9.574.2","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201106-1083OC"},{"issue":"11","key":"2026091522493313000_3.9.574.3","doi-asserted-by":"crossref","first-page":"e0003578","DOI":"10.1371\/journal.pgph.0003578","article-title":"Mycobacterium tuberculosis infection in pregnancy: a systematic review","volume":"4","author":"Morton","year":"2024","journal-title":"PLOS Glob Public Health"},{"issue":"3","key":"2026091522493313000_3.9.574.4","doi-asserted-by":"crossref","first-page":"E337","DOI":"10.1016\/S2214-109X(25)00431-0","article-title":"Global estimates of tuberculosis incidence during pregnancy and postpartum: a rapid review and modelling analysis","volume":"14","author":"Mafirakureva","year":"2026","journal-title":"Lancet Glob Health"},{"key":"2026091522493313000_3.9.574.5","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(04)00939-9"},{"key":"2026091522493313000_3.9.574.6","doi-asserted-by":"publisher","DOI":"10.1093\/jinfdis\/jiq064"},{"issue":"7","key":"2026091522493313000_3.9.574.7","doi-asserted-by":"crossref","first-page":"1125","DOI":"10.1111\/1471-0528.16573","article-title":"Multidrug-resistant tuberculosis during pregnancy and adverse birth outcomes: a systematic review and meta-analysis","volume":"128","author":"Alene","year":"2021","journal-title":"BJOG"},{"key":"2026091522493313000_3.9.574.8","doi-asserted-by":"publisher","DOI":"10.1136\/bmjopen-2023-081209"},{"issue":"12","key":"2026091522493313000_3.9.574.9","doi-asserted-by":"crossref","first-page":"e675","DOI":"10.1016\/S2214-109X(14)70338-9","article-title":"The neglected global burden of tuberculosis in pregnancy","volume":"2","author":"Zumla","year":"2014","journal-title":"Lancet Glob Health"},{"key":"2026091522493313000_3.9.574.10","unstructured":"European AIDS Treatment Group . Community consensus on the earlier inclusion of pregnant women and persons in TB research. Brussels, Belgium: EATG, 2023. https:\/\/www.eatg.org\/hiv-news\/community-consensus-on-the-earlier-inclusion-of-pregnant-women-and-persons-in-tb-research\/."},{"key":"2026091522493313000_3.9.574.11","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/civ991"},{"key":"2026091522493313000_3.9.574.12","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cis732"},{"key":"2026091522493313000_3.9.574.13","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1002882"},{"issue":"1","key":"2026091522493313000_3.9.574.14","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1186\/s12910-017-0194-9","article-title":"A qualitative study on acceptable levels of risk for pregnant women in clinical research","volume":"18","author":"van der Zande","year":"2017","journal-title":"BMC Med Ethics"},{"key":"2026091522493313000_3.9.574.15","unstructured":"A Call to Action . Accelerating research to end tuberculosis in pregnant and lactating women: a call to action. Geneva: World Health Organization, 2025."},{"key":"2026091522493313000_3.9.574.16","unstructured":"World Health Organization . Optimal and early inclusion of pregnant and lactating women in tuberculosis research: consensus statement. Geneva: WHO, 2025."},{"issue":"1","key":"2026091522493313000_3.9.574.17","doi-asserted-by":"crossref","first-page":"160940691771213","DOI":"10.1177\/1609406917712131","article-title":"Rapid and rigorous qualitative data analysis: the \u201cRADaR\u201d technique for applied research","volume":"16","author":"Watkins","year":"2017","journal-title":"Int J Qual Methods"},{"key":"2026091522493313000_3.9.574.18","doi-asserted-by":"publisher","DOI":"10.1186\/s12978-017-0419-x"},{"issue":"6","key":"2026091522493313000_3.9.574.19","doi-asserted-by":"crossref","first-page":"801","DOI":"10.1016\/j.cmi.2021.10.024","article-title":"Characterizing the inclusion of pregnant and breastfeeding people in infectious diseases randomized controlled trials: a targeted literature review","volume":"28","author":"Jorgensen","year":"2022","journal-title":"Clin Microbiol Infect"},{"issue":"3","key":"2026091522493313000_3.9.574.20","doi-asserted-by":"crossref","first-page":"667","DOI":"10.1093\/cid\/ciad583","article-title":"Adverse pregnancy outcomes among women with human immunodeficiency virus taking isoniazid preventive therapy during the first trimester","volume":"78","author":"Gupta","year":"2024","journal-title":"Clin Infect Dis"},{"issue":"14","key":"2026091522493313000_3.9.574.21","doi-asserted-by":"crossref","first-page":"1333","DOI":"10.1056\/NEJMoa1813060","article-title":"Isoniazid preventive therapy in HIV-infected pregnant and postpartum women","volume":"381","author":"Gupta","year":"2019","journal-title":"N Engl J Med"},{"key":"2026091522493313000_3.9.574.22","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz1224"},{"key":"2026091522493313000_3.9.574.23","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2020.08.059"},{"key":"2026091522493313000_3.9.574.24","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.1004405"},{"issue":"2S","key":"2026091522493313000_3.9.574.25","doi-asserted-by":"crossref","first-page":"S135","DOI":"10.1097\/INF.0000000000004699","article-title":"High intention to vaccinate against tuberculosis during pregnancy and lactation: understanding vaccine-specific maternal immunization acceptance in Amhara, Ethiopia","volume":"44","author":"Quincer","year":"2025","journal-title":"Pediatr Infect Dis J"},{"key":"2026091522493313000_3.9.574.26","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14914"},{"key":"2026091522493313000_3.9.574.27","unstructured":"SMART4TB Consortium . Community consensus on the earlier inclusion of pregnant women and persons in TB research. Washington, DC: United States Agency for International Development (USAID), 2024."},{"key":"2026091522493313000_3.9.574.28","doi-asserted-by":"publisher","DOI":"10.1186\/s13063-017-2402-9"}],"container-title":["IJTLD Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.5588\/ijtldopen.26.0107","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,16]],"date-time":"2026-09-16T05:49:42Z","timestamp":1789537782000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.theunion.org\/lookup\/doi\/10.5588\/ijtldopen.26.0107"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":28,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2026,9,1]]},"published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.5588\/ijtldopen.26.0107"],"URL":"https:\/\/doi.org\/10.5588\/ijtldopen.26.0107","relation":{},"ISSN":["3005-7590"],"issn-type":[{"value":"3005-7590","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9]]}}}