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Interferon-γ ELISPOT as a biomarker of treatment efficacy in latent tuberculosis infection a clinical trial
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Adetifa, I. M., Ota, M. O. C., Jeffries, D. J., Lugos, M. D., Hammond, A. S., Battersby, N. J., Owiafe, P. K., Donkor, S. D., Antonio, Martin, Ibanga, H. B., Brookes, R. H., Aka, P., Walton, Robert T., Adegbola, R. A. and Hill, P. C. (2013) Interferon-γ ELISPOT as a biomarker of treatment efficacy in latent tuberculosis infection a clinical trial. American Journal of Respiratory and Critical Care Medicine, 187 (4). pp. 439-445. doi:10.1164/rccm.201208-1352OC
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Official URL: https://doi.org/10.1164/rccm.201208-1352OC
Abstract
Rationale: Biomarkers that can be used to evaluate new interventions against latent tuberculosis infection (LTBI) and predict reactivation TB disease are urgently required. Objectives: To evaluate ESAT-6 and CFP-10 (EC) IFN-g ELISPOT as a biomarker for treatment efficacy in LTBI. Methods: This was a randomized, blinded, and placebo-controlled trial of INH in EC ELISPOT and Mantoux test positive participants. Measurements and Main Results: Participants received a 6-month course of 900 mg INH twice weekly or a matching placebo. INH acetylator genotypes were determined and urine tested for INH metabolites to confirm adherence. The proportion of positive responders for CFP-10 and ESAT-6 between treatment armswas comparedusing mixed effects logistic regression models. A Tweedie (compound Poisson) model was fitted to allow for zero inflation and overdispersionofquantitativeresponse. The proportionsofECELISPOT- positive subjects reduced over time (P,0.001) but did not differby study arm (P = 0.36). Median spot-forming units for ESAT-6 and CFP-10 also declined significantly with time (P,0.001) but did not differby study arm (P = 0.74 and 0.71, respectively). There was no evidence of an interactionbetween acetylator status and INHtreatmentwithrespect to ELISPOT results over time. Conclusions: In contacts with LTBI, INH therapy plays no role in observed decreases in Mycobacterium tuberculosis antigen-specific T-cell responses over time. IFN-g ELISPOT is probably not a useful biomarker of treatment efficacy in LTBI. Clinical trial registered with www.clinicaltrials.gov (NCT 00130325).
| Item Type: | Journal Article | ||||||
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| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Medicine > Warwick Medical School |
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| Journal or Publication Title: | American Journal of Respiratory and Critical Care Medicine | ||||||
| Publisher: | American Thoracic Society | ||||||
| ISSN: | 1073-449X | ||||||
| Official Date: | 15 February 2013 | ||||||
| Dates: |
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| Volume: | 187 | ||||||
| Number: | 4 | ||||||
| Page Range: | pp. 439-445 | ||||||
| DOI: | 10.1164/rccm.201208-1352OC | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Publisher Statement: | cited By 23 | ||||||
| Access rights to Published version: | Open Access |
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