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An open phase 1, dose-escalating, clinical trial on the safety of a new liposomal adjuvant system, CAF01, when given with the tuberculosis subunit vaccine Ag85B-ESAT-6 as two injections with two months interval to healthy adult volunteers.

Primary:The primary objective is to evaluate the safety profile of an adjuvated Tb subunit vaccine (CAF01) administered in 50 µg Ag85B-Esat-6 alone, 50 µg Ag85B-Esat-6 alone with three escalating CAF01 dose levels, to four groups of healthy…

Validation of Interferon Gamma Release Assays (IGRA) using frozen Peripheral Blood Mononuclear Cells (PBMC)

Determining the impact of freezing PBMC on the test result of the IGRA.

Tuberculin specific T-cell response after intravesical BCG-instillations.

1. Monitoring of cellular (T-cel) specifc immune response in bladder and bloodsamples after intravesical BCG- therapy. 2. Monitoring and comparing T-cell responses after BCG therapy in patients with clinical BCG-related complications to the T-…

Clinical validation of the dried blood spot analysis for antituberculosis drugs

The objective of this study is to validate drug concentration measurement using DBS by comparing the results of blood samples routinely withdrawn from venous blood versus withdrawn by finger prick and transferred to filter paper to make dried blood…

Enhancement of the sensitivity of a whole-blood interferon gamma assay (Quantiferon TB Gold) for diagnosis of latent tuberculosis infection

Enhancement of the sensitivity of the Quantiferon test for patients with an inflammatory disease who are screened for presence of latent tuberculosis infection.

Breath, sputum, serum and urine analysis for the diagnosis of tuberculosis; characterisation of volatile biomarkers for TB

The aim of our study is the development of a simple device that is able to differentiate between sputum from TB patients and non TB patients.With the knowledge and concentration of the VOCs from M. tuberculosis and possible the specific host…

A safety and immunogenicity phase 1 trial with an adjuvated TB subunit vaccine (Ag85B - ESAT-6 + IC31) administered in PPD positive volunteers at 0 and 2 months

Primary objective:The primary objective is to evaluate the safety of an adjuvated TB subunit vaccine administered in PPD positive volunteers at 0 and 2 months.Secondary objective:The secondary objective is to determine the immunogenicity profile of…

QUantiferon in Active and Latent Infection with Tuberculous mYcobacteria

Primary Objectives: To explore whether QFT-plus is equipped to differentiate between active TB disease and latent TB infectionTo explore a possible correlation between QFT-plus response and time after TB-infection and/or diagnosis tuberculosis /…

Evaluation of ultra low-dose CT for detection of latent tuberculosis

Primary Objectives:1. To determine the proportion of patients with any of various predefined lesions suggestive of old TB infection detected by ULDCT in patients with LTBI as defined by TST or IGRA result, but without any LTBI-lesions on CXR2. To…

Evaluation of the kinetics of a whole blood assay ( quantiferon- TB Gold) measuring M. Tuberculosis-specific immune responses in military personnel with a positive tuberculin skin test

Objectives* The primary aim is to study the kinetics of QFT-G in military personnel with a positive TST result. * Secondary aims are to study the practical feasibility of using QFT-G in the setting of a military hospital.Next to this we wish to…