Background Tuberculosis remains one of the world's deadliest transmissible diseases despite the widespread use of BCG. MTBVAC is a new live tuberculosis vaccine based on a genetically attenuated phoP-/fadD26-deletion mutant of M. tuberculosis that expresses most antigens present in human isolates in contrast to BCG. Methods We conducted this randomized, double-blind, controlled phase I study at CHUV, Lausanne, Switzerland, to compare MTBVAC to BCG in healthy, PPD-negative adults. Primary outcome was safety in all vaccinated participants. Secondary outcome included whole blood cell mediated immune response to live MTBVAC and BCG as well as interferon-gamma release assay (IGRA) on peripheral blood mononuclear cells. Volunteers fulfilling the inclusion criteria were randomly allocated (on a 3:1 basis) in a dose-escalation manner to three cohorts. Each cohort included 9 subjects who were injected with MTBVAC 5x10 3 , 5x10 4 , or 5x10 5 colony forming units (CFU) in 0.1 mL and 3 subjects with BCG (single dose of 5x10 5 CFU in 0.1 mL). Each subject received a single intradermal injection in the non-dominant arm starting with the lowest MTBVAC dose. Findings Thirty-six volunteers were recruited. Vaccination with MTBVAC (5x10 3 , 5x10 4 , 5x10 5 CFU/0.1mL) was as safe as with BCG, and did not induce serious adverse events. All individuals were IGRA negative at the end of follow-up (D210). After whole blood stimulation with live MTBVAC or BCG, MTBVAC was immunogenic in a dosedependent manner. At the same dose level as BCG (5x10 5 CFU), although no

Summary Auto‐reactive cytotoxic T lymphocytes play a key role in the progressive loss or destruction of melanocytes in vitiligo but the mechanism underlying the loss of self‐tolerance is unknown. A deregulation of regulatory T‐cell biology has recently been suggested. The analysis of the suppressive effects of peripheral T regulatory cells in vitiligo patients revealed a functional defect in seven of 15 cases. This defect was strongly correlated with disease activity. The evaluation of the percentage of peripheral regulatory T lymphocytes did not reveal any intrinsic quantitative defect. Yet, a decrease in the percentage of such cells was noted in patients with progressive forms, suggesting a recruitment of regulatory T cells from the peripheral blood to the site of injury. This was further corroborated by the significant increase of Forkhead box P3 expression in the vitiliginous skin of patients. Our data support the involvement of a functional defect of peripheral regulatory T cells in the pathogenesis of vitiligo and open new possibilities to advance therapeutic approaches.

This trial was registered in clinicaltrials.gov (NCT01949909) and www.pactr.org (PACTR201310000683408).

<b><i>Background:</i></b> Clinically meaningful specific IgE determination is an important step in the diagnosis of allergic diseases. While patient’s history and skin prick tests are available during the medical visit, most IgE immunoassays require hours to several days to be available. Recent developments in the field of nanofluidic technology open new horizons for point-of-care management of this unmet medical need. <b><i>Objective:</i></b> This study aimed to compare IgE diagnostic agreement between a nanofluidic assay (abioSCOPE®) and a laboratory reference method (Phadia Laboratory System®) in a real-world clinical setting. <b><i>Methods:</i></b> Sera from 105 patients whose routine allergy diagnostic workup required a blood sampling were used to compare the novel nanofluidic IgE assay to a reference method in a blind manner for a panel of five respiratory allergens. To assess the agreement between methods, patient records were reviewed by four independent experts to establish the final diagnosis. Experts were blinded to the IgE serological method used, but had access to patient history, skin prick tests, and blood test results. <b><i>Results:</i></b> Analytic agreement between the two methods was 81% for the tested panel of allergens (ranging from 77 to 89%). The overall agreement in clinical diagnosis decision taken by the expert panel was 94.6% with the nanofluidic IgE assay when compared to the reference method. <b><i>Conclusion:</i></b> The nanofluidic IgE assay, as determined through an evaluation based on clinical history, skin prick tests, and IgE measurement, is a valuable tool for allergy experts to identify patients’ sensitization patterns at the point of care, and for routine IgE diagnostic workup.