Abstract
Background: Recurrent wheezing affects one third of children being a global health problem with considerable expenditure and impact on quality of life. Virtually all wheezing attacks (WA) in young children are of viral etiology. Their prevention is a major concern as effective therapies are still lacking.
Aims: To evaluate the efficacy and safety of a mucosal whole-cell inactivated polybacterial preparation (MV130) in the prevention of WA, and to investigate the underlying mechanism of action.
Methods: A randomized, double-blind, placebo-controlled, parallel-group study, including 120 children <3 years old with ≥3 episodes of wheezing during the previous year was performed. Children received (sublingual) active treatment (MV130) or placebo for 6 months daily, being the number of WA during 1 year the main outcome. In parallel, the possible antiviral mechanism of MV130 was addressed experimentally.
Results: A reduction of 40% in the number of WA in the active vs the placebo group (p<0.001) was observed. Secondary outcomes including symptoms and medication scores were also significantly improved in the active group. Only minor adverse events, not considered to be related to the treatment, were registered in 9.2% of participants (active and placebo).
Administration of MV130 conferred protection to intranasal viral infection in mice. This non-specific resistance was mediated by trained immunity.
Conclusion: We provide evidence for the first time that a mucosal (sublingual) polybacterial formulation induces trained immunity, confers broad protection beyond the pathogens included in the preparation and shows clinical efficacy against a virus-related condition such as WA, with an excelent safety profile.
Footnotes
Cite this article as: European Respiratory Journal 2019; 54: Suppl. 63, PA4998.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2019