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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., Modulating the host immune response during tuberculosis is an emerging and critical advance in the therapeutic approach. Here the authors present data from a first-in-human phase I/II randomised trial on the safety and immunogenicity of adjuvant therapy of the H56:IC31 vaccine and cyclooxygenase-2 inhibitors in patients with tuberculosis.

The SMA-TB Consortium has developed a leaflet with basic information on Tuberculosis to be distributed to general public during communication activities. This leaflet was created within the SMA-TB Project jointly by the IGTP team andthe Public Health Agency of Barcelona (ASPB). The Fundació Lluita contra les Infeccions (Fight Infections Foundation)has also contributed to it,and Laura Ginès and Pepón Meneses illustrated it. Theleaflethas been translated toseveral languagesbymembers of theSMA-TB Consortium partners (all listed as contributors)in order others can reuse it: Catalan Spanish French Italian Portuguese Polish Deutsch Norwegian Ukrainian Georgian Afrikaans Per each language, two versions are provided: one to be printed in a home printer and another one to be printed in a printshop.