{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T07:39:21Z","timestamp":1792741161181,"version":"4.5.0"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2024,4,1]],"date-time":"2024-04-01T00:00:00Z","timestamp":1711929600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000866","name":"IAVI","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000866","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000865","name":"Bill and Melinda Gates Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000865","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,11,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>H56:IC31 is a candidate vaccine against tuberculosis (TB) with the potential to reduce TB recurrence rate. It is thus important for future clinical trials to demonstrate safety and immunogenicity of H56:IC31 in individuals treated for TB.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Twenty-two adults confirmed to be Mycobacterium tuberculosis negative (by 2 GeneXpert tests or 2 sputum cultures) after 4\u20135 months of TB treatment, and not more than 28 days after completion of TB treatment, were randomized to receive 2 doses of H56:IC31 (5\u2005mg H56:500\u2005nmol IC31; n = 16) or placebo (n = 6) 56 days apart. Participants were followed for 420 days for safety and immunogenicity.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>H56:IC31 vaccination was associated with an acceptable safety profile, consisting mostly of mild self-limited injection site reactions. No serious adverse events or vaccine-related severe adverse events were reported. H56:IC31 induced a CD4+ T-cell response for Ag85B and ESAT-6, with ESAT-6 being immunodominant, which persisted through 6 months after the last vaccination. There was some evidence of CD8+ T-cell responses for both Ag85B and ESAT-6, but to a lesser extent than CD4+ responses.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>H56:IC31 was associated with an acceptable safety profile, and induced a predominant CD4+ T-cell response, in adults recently treated for drug-susceptible, uncomplicated pulmonary TB.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trials Registration<\/jats:title>\n                  <jats:p>NCT02375698.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/infdis\/jiae170","type":"journal-article","created":{"date-parts":[[2024,4,1]],"date-time":"2024-04-01T11:10:18Z","timestamp":1711969818000},"page":"1262-1270","source":"Crossref","is-referenced-by-count":18,"title":["Safety and Immunogenicity of the H56:IC31 Tuberculosis Vaccine Candidate in Adults Successfully Treated for Drug-Susceptible Pulmonary Tuberculosis: A Phase 1 Randomized Trial"],"prefix":"10.1093","volume":"230","author":[{"given":"Dereck","family":"Tait","sequence":"first","affiliation":[{"name":"Independent Consultant"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Diacon","sequence":"additional","affiliation":[{"name":"TASK Clinical Research Centre , Cape Town ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2020-3828","authenticated-orcid":false,"given":"\u00c1lvaro H","family":"Borges","sequence":"additional","affiliation":[{"name":"Department of Infectious Disease Immunology, Statens Serum Institut , Copenhagen ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elana","family":"van Brakel","sequence":"additional","affiliation":[{"name":"IAVI (Formerly Aeras) , Cape Town ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Hokey","sequence":"additional","affiliation":[{"name":"Aeras , Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn T","family":"Rutkowski","sequence":"additional","affiliation":[{"name":"IAVI (Formerly Aeras) , Cape Town ,","place":["South Africa"]},{"name":"Aeras , Rockville, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Devin J","family":"Hunt","sequence":"additional","affiliation":[{"name":"IAVI (Formerly Aeras) , Cape Town ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marisa","family":"Russell","sequence":"additional","affiliation":[{"name":"IAVI (Formerly Aeras) , Cape Town ,","place":["South Africa"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter L","family":"Andersen","sequence":"additional","affiliation":[{"name":"Novo Nordisk Foundation , Hellerup"},{"name":"Department of Immunology and Microbiology, University of Copenhagen"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingrid","family":"Kromann","sequence":"additional","affiliation":[{"name":"Department of Vaccine Development, Statens Serum Institut , Copenhagen ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morten","family":"Ruhwald","sequence":"additional","affiliation":[{"name":"Department of Infectious Disease Immunology, Statens Serum Institut , Copenhagen ,","place":["Denmark"]},{"name":"Foundation of Innovative New Diagnostics , Geneva ,","place":["Switzerland"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gavin","family":"Churchyard","sequence":"additional","affiliation":[{"name":"Aurum Institute"},{"name":"School of Public Health, Faculty of Health Sciences, University of the Witwatersrand , Johannesburg ,","place":["South Africa"]},{"name":"Department of Medicine, Vanderbilt 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