Abstract

BackgroundPolyvalent Mechanical Bacterial Lysate (PMBL®) contains antigens of bacteria responsible for respiratory infections. PMBL® has been proven to reduce the number of respiratory infections, and in its use, immunological benefits have been seen in allergic patients. PMBL® activates both innate and specific immune responses. The lysate induces dendritic cells, T and B lymphocytes and IgA secretion, as well as the production of antibodies directed against administered bacterial antigens. Moreover, it increases the response against other bacteria and viruses. The immunologic mechanism of lysate’s action is not yet clearly determined. The objective of this study was to assess the effect of PMBL® on T cells in children with allergic asthma.MethodsThis study was a part of the EOLIA study. Herein, 49 children with allergic asthma and house dust mites allergy were included: 21 in PMBL® and 28 in the Placebo group, both, drug and placebo were administered sublingually. The tests were done at baseline and 12 weeks after the last tablet intake. The lymphocytes CD45+, lymphocytes T CD3+, CD3+CD25+, CD3+CD69+, Th CD3+CD4+, CD4+CD25+, CD4+CD25+ high, CD4+CD69+, Treg CD4+CD25+FOXP3, Tc CD3+CD8+, CD8+CD25+, CD8+CD69+, NK-like T CD3+CD16+CD56+ and NK cells CD3−CD16+CD56+ were described.ResultsAt baseline, no significant differences between groups relative to blood count cells were observed, except for eosinophils. After 12 weeks, we observed an increase of T lymphocytes count. In addition, CD4+CD25+FOXP3+, CD8+ and CD3−CD16+CD56+ and (insignificantly) Th count increased. However, CD69+ and CD25+ subset of CD3+ significantly decreased.ConclusionsThe EOLIA study demonstrated that PMBL® administration 10 days per month for 3 months changed the panel of T lymphocytes.Trial registration Clinical Trial Registration: This study was a part of the EOLIA (Efficacy Of mechanical bacterial Lysate In Allergic children), a clinical study NCT02541331. Frederic Durmont, MD Lallemand Pharma International AG. Date of registration 09/08/2013. URL of trial registry record: https://clinicaltrials.gov/ct2/show/study/NCT02541331.

Highlights

  • Polyvalent Mechanical Bacterial Lysate (PMBL®) contains antigens of bacteria responsible for respiratory infections

  • This initial stimulation of innate immune system is brought about by the recruitment of a functionally efficient population of T and B lymphocytes, and results in the secretion of specific IgA and production of opsonizing antibodies directed against the administered bacterial antigens [6, 7]

  • This study was a part of the EOLIA (Efficacy Of mechanical bacterial Lysate In Allergic children, NCT02541331), a clinical study on the clinical course of asthma and related immunological parameters in asthmatic children

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Summary

Introduction

Polyvalent Mechanical Bacterial Lysate (PMBL®) contains antigens of bacteria responsible for respiratory infections. The lysate induces dendritic cells, T and B lymphocytes and IgA secretion, as well as the production of antibodies directed against administered bacterial antigens. It increases the response against other bacteria and viruses. PMBL induces a specific immune-stimulation against the 13 bacterial strains, activates both innate and specific immune responses and has the capacity of inducing maturation of dendritic cells [1] This initial stimulation of innate immune system is brought about by the recruitment of a functionally efficient population of T and B lymphocytes, and results in the secretion of specific IgA and production of opsonizing antibodies directed against the administered bacterial antigens [6, 7]. The demonstration of a polyclonal activity of PMBL seems to be important in suggesting that an efficient immune response could be raised by treatment, towards pathogens present in PMBL, and to other bacteria and viruses responsible for respiratory infections [5, 8]

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