dc.contributor.author | Jenum, Synne | |
dc.contributor.author | Tonby, Kristian | |
dc.contributor.author | Rueegg, Corina Silvia | |
dc.contributor.author | Ruhwald, Morten | |
dc.contributor.author | Kristiansen, Max Per | |
dc.contributor.author | Bang, Peter | |
dc.contributor.author | Olsen, Inge Christoffer | |
dc.contributor.author | Sellæg, Kjersti | |
dc.contributor.author | Røstad, Kjerstin | |
dc.contributor.author | Mustafa, Tehmina | |
dc.contributor.author | Tasken, Kjetil | |
dc.contributor.author | Kvale, Dag | |
dc.contributor.author | Mortensen, Rasmus | |
dc.contributor.author | Riise, Anne Margarita Dyrhol | |
dc.date.accessioned | 2022-01-31T13:08:41Z | |
dc.date.available | 2022-01-31T13:08:41Z | |
dc.date.created | 2022-01-05T10:49:44Z | |
dc.date.issued | 2021 | |
dc.identifier.issn | 2041-1723 | |
dc.identifier.uri | https://hdl.handle.net/11250/2976013 | |
dc.description.abstract | Host-directed-therapy strategies are warranted to fight tuberculosis. Here we assess the safety and immunogenicity of adjunctive vaccination with the H56:IC31 candidate and cyclooxygenase-2-inhibitor treatment (etoricoxib) in pulmonary and extra-pulmonary tuberculosis patients in a randomized open-label phase I/II clinical trial (TBCOX2, NCT02503839). A total of 222 patients were screened, 51 enrolled and randomized; 13 in the etoricoxib-group, 14 in the H56:IC31-group, 12 in the etoricoxib+H56:IC31-group and 12 controls. Three Serious Adverse Events were reported in the etoricoxib-groups; two urticarial rash and one possible disease progression, no Serious Adverse Events were vaccine related. H56:IC31 induces robust expansion of antigen-specific T-cells analyzed by fluorospot and flow cytometry, and higher proportion of seroconversions. Etoricoxib reduced H56:IC31-induced T-cell responses. Here, we show the first clinical data that H56:IC31 vaccination is safe and immunogenic in tuberculosis patients, supporting further studies of H56:IC31 as a host-directed-therapy strategy. Although etoricoxib appears safe, our data do not support therapy with adjunctive cyclooxygenase-2-inhibitors. | en_US |
dc.language.iso | eng | en_US |
dc.publisher | Nature | en_US |
dc.rights | Navngivelse 4.0 Internasjonal | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/deed.no | * |
dc.title | A Phase I/II randomized trial of H56:IC31 vaccination and adjunctive cyclooxygenase-2-inhibitor treatment in tuberculosis patients | en_US |
dc.type | Journal article | en_US |
dc.type | Peer reviewed | en_US |
dc.description.version | publishedVersion | en_US |
dc.rights.holder | Copyright 2021 The Author(s) | en_US |
dc.source.articlenumber | 6774 | en_US |
cristin.ispublished | true | |
cristin.fulltext | original | |
cristin.qualitycode | 2 | |
dc.identifier.doi | 10.1038/s41467-021-27029-6 | |
dc.identifier.cristin | 1974962 | |
dc.source.journal | Nature Communications | en_US |
dc.identifier.citation | Nature Communications. 2021, 12, 6774 | en_US |
dc.source.volume | 12 | en_US |