TBDERMATEST

Development of a novel skin test using the HBHA antigen for the diagnosis of latent M. tuberculosis infection

TBDERMATEST est accrédité par Lyonbiopôle

Identity card

Global budget: 4342 k€

Public funding: 2048 k€

Public funders: Conseil général de l'Isère, Fonds Unique Interministériel (FUI) – DGCIS/Oséo, Grand Lyon, Grenoble Alpes Métropole, Région Rhône-Alpes, Ville de Grenoble

Call for projects: FUI (FUI AAP6)

Year start: 2008

Completed project (2012-10)


Accredited by the French competitiveness cluster Lyonbiopôle


Strategic business area: Human Medicines, In vivo diagnostic

Application fields: Infectious diseases

Technological approaches / Keywords: Bioinformatics / Software, Biologics, Biomanufacturing, Immunotherapy, Minimally Invasive Technologies

Stage of development at the beginning of the project: Preclinical development

Abstract

Approximately 2 billion individuals are estimated to be latently infected with the causative agent of Tuberculosis (TB), Mycobacterium tuberculosis and represent an important reservoir for future active TB cases. The most widely used diagnostic test for latent TB infection (tuberculin skin test) suffers from many limitations. TB Dermatest aims at assessing the potential of HBHA antigen as an improved skin test reagent and at developping a novel delayed type hypersensitivity skin test based upon the antigen of interest contained in the BD microinjection device.


Objectives

The objective is to develop as a proof of concept a safe, easy and ready to use (point of care test), innovative, reliable and cost-effective delayed type hypersensitivity DTH skin test for the clinical diagnosis of latent TB. The test is based on the intradermic injection of the highly selective MT HBHA antigen by applying the BD intradermic microinjection delivery system.


Innovative assets
Highlights
Actual results
Perspectives

Innovative assets

A cGMP manufacturing process of HBHA was developped during this project from a BCG biomass. A recombinant HBHA was also produced in E. coli. Non regulatory preclinical studies in pig showed that HBHA does not induce local effect as well as systemic effect and did not induce delayed hypersensitivity reaction on BCG vaccinated pig. A clinical study allowed to validate the BD micro-needle in comparison with the Mantoux system with the tuberculine antigenes. The reading system (pilot stage) for the skin test gave promising results during its clinical   evaluation    

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