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dc.contributor.authorJenum, Synne
dc.contributor.authorTonby, Kristian
dc.contributor.authorRueegg, Corina Silvia
dc.contributor.authorRuhwald, Morten
dc.contributor.authorKristiansen, Max Per
dc.contributor.authorBang, Peter
dc.contributor.authorOlsen, Inge Christoffer
dc.contributor.authorSellæg, Kjersti
dc.contributor.authorRøstad, Kjerstin
dc.contributor.authorMustafa, Tehmina
dc.contributor.authorTasken, Kjetil
dc.contributor.authorKvale, Dag
dc.contributor.authorMortensen, Rasmus
dc.contributor.authorRiise, Anne Margarita Dyrhol
dc.date.accessioned2022-01-31T13:08:41Z
dc.date.available2022-01-31T13:08:41Z
dc.date.created2022-01-05T10:49:44Z
dc.date.issued2021
dc.identifier.issn2041-1723
dc.identifier.urihttps://hdl.handle.net/11250/2976013
dc.description.abstractHost-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.isoengen_US
dc.publisherNatureen_US
dc.rightsNavngivelse 4.0 Internasjonal*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/deed.no*
dc.titleA Phase I/II randomized trial of H56:IC31 vaccination and adjunctive cyclooxygenase-2-inhibitor treatment in tuberculosis patientsen_US
dc.typeJournal articleen_US
dc.typePeer revieweden_US
dc.description.versionpublishedVersionen_US
dc.rights.holderCopyright 2021 The Author(s)en_US
dc.source.articlenumber6774en_US
cristin.ispublishedtrue
cristin.fulltextoriginal
cristin.qualitycode2
dc.identifier.doi10.1038/s41467-021-27029-6
dc.identifier.cristin1974962
dc.source.journalNature Communicationsen_US
dc.identifier.citationNature Communications. 2021, 12, 6774en_US
dc.source.volume12en_US


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Navngivelse 4.0 Internasjonal
Except where otherwise noted, this item's license is described as Navngivelse 4.0 Internasjonal