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The aim of the present study was to evaluate the efficacy of the immunosti-mulating therapy with a new vaccine Ismigen® in preventing recurrent infections of the upper respiratory tract in subjects belonging to a community of cloistered nuns. This product is a lysate obtained by mechanical lysis of bacteria (MLBL) usually responsible of respiratory tract infections. A randomized, double-blind, parallel groups, placebo controlled clinical trial was carried out in 47 nuns (age range 25-84) years) living in a cloistered religious community, suffering from recurrent infections of the upper respiratory tract. The 47 patients were allocated by randomization to two groups: Group A - The 24 patients (mean age ± SI): 48.12 ± 14.25 years) of this group received one sublingual tablet of MLBL per day, for 10 consecutive days per month for 3 consecutive months (October, November and December 2001). Group B - The 23 patients (mean age ± SI): 49.04 ± 14.73 years) of this group received daily one sublingual tablet of taste masked placebo, for 10 consecutive days per month for 3 consecutive months (October, November and December 2001). At the end of the treatment period patients of both groups were followed up for further three months without any immunostimulating treatment. Results: During and at the end of the treatment phase the number of respiratory infections (primary end-point) and their duration were statistically significantly lower in the MLBL group than in the placebo group. Moreover the administration of MLBL induced a marked reduction in the number of patients showing symptoms of infection in comparison to baseline and approximately 79 % of the patients showed an improvement of one or more of the evaluated symptoms. [ABSTRACT FROM AUTHOR]

Purpose: Lung cancer is the most common cause of death from cancer worldwide, largely due to late diagnosis. Thus, there is an urgent need to develop new approaches to improve the detection of early-stage lung cancer, which would greatly improve patient survival., Experimental Design: The quantitative protein expression profiles of microvesicles isolated from the sera from 46 lung cancer patients and 41 high-risk non-cancer subjects were obtained using a mass spectrometry method based on a peptide library matching approach., Results: We identified 33 differentially expressed proteins that allow discriminating the two groups. We also built a machine learning model based on serum protein expression profiles that can correctly classify the majority of lung cancer cases and that highlighted a decrease in the levels of Arysulfatase A (ARSA) as the most discriminating factor found in tumors., Conclusions and Clinical Relevance: Our study identified a preliminary, non-invasive protein signature able to discriminate with high specificity and selectivity early-stage lung cancer patients from high-risk healthy subjects. These results provide the basis for future validation studies for the development of a non-invasive diagnostic tool for lung cancer., (© 2023 The Authors. Proteomics - Clinical Applications published by Wiley-VCH GmbH.)

Unlabelled: The aim of the present study was to evaluate the efficacy of the immunostimulating therapy with a new vaccine Ismigen in preventing recurrent infections of the upper respiratory tract in subjects belonging to a community of cloistered nuns. This product is a lysate obtained by mechanical lysis of bacteria (MLBL) usually responsible of respiratory tract infections. A randomized, double-blind, parallel groups, placebo controlled clinical trial was carried out in 47 nuns (age range 25-80 years) living in a cloistered religious community, suffering from recurrent infections of the upper respiratory tract. The 47 patients were allocated by randomization to two groups: Group A--The 24 patients (mean age SD: 48.12 +/- 14.25 years) of this group received one sublingual tablet of MLBL per day, for 10 consecutive days per month for 3 consecutive months (October, November and December 2001). Group B--The 23 patients (mean age +/- SD: 49.04 +/- 14.73 years) of this group received daily one sublingual tablet of taste masked placebo, for 10 consecutive days per month for 3 consecutive months (October, November and December 2001). At the end of the treatment period patients of both groups were followed up for further three months without any immunostimulating treatment., Results: During and at the end of the treatment phase the number of respiratory infections (primary end-point) and their duration were statistically significantly lower in the MLBL group than in the placebo group. Moreover the administration of MLBL induced a marked reduction in the number of patients showing symptoms of infection in comparison to baseline and approximately 79 % of the patients showed an improvement of one or more of the evaluated symptoms. In the MLBL group a statistically significant increase of serum immunoglobulins (IgG +35%; IgM +86%; IgA +80 %) and salivary IgA (+110%) was found, in comparison to baseline; on the contrary no significant differences were observed in the placebo group. The beneficial effects of MLBL found in the treatment period were maintained also in the three-month follow-up. No adverse events associated with the treatment were found in both group. The results of this study demonstrate that MLBL is an efficacious and safe therapeutic option for the treatment and prevention of recurrent upper respiratory tract infections and that its use is recommended in subjects with a possible immune deficit.