A Phase I/II randomized trial of H56:IC31 vaccination and adjunctive cyclooxygenase-2-inhibitor treatment in tuberculosis patients

Synne Jenum, Kristian Tonby, Corina S. Rueegg, Morten Rühwald, Max P. Kristiansen, Peter Bang, Inge Christoffer Olsen, Kjersti Sellæg, Kjerstin Røstad, Tehmina Mustafa, Kjetil Taskén, Dag Kvale, Rasmus Mortensen and Anne Ma Dyrhol-Riise ()
Additional contact information
Synne Jenum: Oslo University Hospital
Kristian Tonby: Oslo University Hospital
Corina S. Rueegg: Oslo University Hospital
Morten Rühwald: Statens Serum Institut Artillerivej 5
Max P. Kristiansen: Statens Serum Institut
Peter Bang: Statens Serum Institut
Inge Christoffer Olsen: Oslo University Hospital
Kjersti Sellæg: Oslo University Hospital
Kjerstin Røstad: Oslo University Hospital
Tehmina Mustafa: University of Bergen
Kjetil Taskén: University of Oslo
Dag Kvale: Oslo University Hospital
Rasmus Mortensen: Statens Serum Institut Artillerivej 5
Anne Ma Dyrhol-Riise: Oslo University Hospital

Nature Communications, 2021, vol. 12, issue 1, 1-13

Abstract: 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.

Date: 2021
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
https://www.nature.com/articles/s41467-021-27029-6 Abstract (text/html)

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:nat:natcom:v:12:y:2021:i:1:d:10.1038_s41467-021-27029-6

Ordering information: This journal article can be ordered from
https://www.nature.com/ncomms/

DOI: 10.1038/s41467-021-27029-6

Access Statistics for this article

Nature Communications is currently edited by Nathalie Le Bot, Enda Bergin and Fiona Gillespie

More articles in Nature Communications from Nature
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().