Protective Efficacy in a Hamster Model of a Multivalent Vaccine for Human Visceral Leishmaniasis (MuLeVaClin) Consisting of the KMP11, LEISH-F3+, and LJL143 Antigens in Virosomes, Plus GLA-SE Adjuvant.

Visceral leishmaniasis (VL) is the most severe clinical form of leishmaniasis, fatal if untreated. Vaccination is the most cost-effective approach to disease control; however, to date, no vaccines against human VL have been made available. This work examines the efficacy of a novel vaccine consisting of the Leishmania membrane protein KMP11, LEISH-F3+ (a recombinant fusion protein, composed of epitopes of the parasite proteins nucleoside hydrolase, sterol-24-c-methyltransferase, and cysteine protease B), and the sand fly salivary protein LJL143, in two dose ratios. The inclusion of the TLR4 agonist GLA-SE as an adjuvant, and the use of virosomes (VS) as a delivery system, are also examined. In a hamster model of VL, the vaccine elicited antigen-specific immune responses prior to infection with Leishmania infantum. Of note, the responses were greater when higher doses of KMP11 and LEISH-F3+ proteins were administered along with the GLA-SE adjuvant and/or when delivered within VS. Remarkably, hamsters immunized with the complete combination (i.e., all antigens in VS + GLA-SE) showed significantly lower parasite burdens in the spleen compared to those in control animals. This protection was underpinned by a more intense, specific humoral response against the KMP11, LEISH-F3+, and LJL143 antigens in vaccinated animals, but a significantly less intense antibody response to the pool of soluble Leishmania antigens (SLA). Overall, these results indicate that this innovative vaccine formulation confers protection against L. infantum infection, supporting the advancement of the vaccine formulation into process development and manufacturing and the conduction of toxicity studies towards future phase I human clinical trials.

Prospective observational study on the characteristics of eosinophilic esophagitis in southeast Spain.

INTRODUCTION: Eosinophilic esophagitis (EoE) is a chronic esophageal atopic disease because sensitization to aeroallergens and foods allergens is very common. OBJECTIVES: This study is the first work that studies multiple characteristics of EoE in the southeast of Spain to know whether EoE in the patients of this region is similar to that of other regions of Spain in terms of demography, symptoms, and atopic characteristics. METHOD: It is an observational prospective study of patients diagnosed with EoE at Granada (Spain). We recorded demographic data (age, sex, and personal history of atopy), clinical data (impaction and dysphagia), allergologic data (prick test and specific immunoglobulin E) to foods, aeroallergen, and pan-allergens, and other endoscopic-histologic data and comorbidities. RESULTS: The demographic, allergologic, and endoscopic characteristics of patients with EoE in Granada were similar to the rest of Spain, except the higher frequency of sensitization to olive pollen, food allergy, and anaphylaxis reactions. CONCLUSIONS: The higher frequency of sensitization to olive pollen and food allergy with severe clinical manifestations (anaphylaxis) in patients with EoE in Granada could have a negative impact on patients' quality of life.