Journal
AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
Volume 204, Issue 4, Pages 462-472Publisher
AMER THORACIC SOC
DOI: 10.1164/rccm.202003-0520OC
Keywords
clinical trial; wheeling attacks; mucosal vaccination; MV130
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Funding
- INNPACTO [IPT-2012-0639-090000]
- Spanish Ministry of Economy, Industry, and Competitiveness (MINECO), Spain
- MINECO [BES-2014-069933]
- European Respiratory Society Fellowship [RESPIRE2-2013-3708]
- Ministerio de Ciencia e Innovacion
- Pro-CNIC Foundation
- Severo Ochoa Center of Excellence [SEV-2015-0505]
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The study demonstrates the clinical efficacy and safety of mucosal bacterial immunotherapy with MV130 in preventing recurrent wheezing attacks (WA) in children.
Rationale: Recurrent wheezing in children represents a severe public health concern. Wheezing attacks (WA), mainly associated with viral infections, lack effective preventive therapies. Objectives: To evaluate the efficacy and safety of mucosal sublingual immunotherapy based on whole inactivated bacteria (MV130) in preventing WA in children. Methods: A Phase 3 randomized, double-blind, placebo-controlled, parallel-group trial including a cohort of 120 children <3 years old with >= 3 WA during the previous year was conducted. Children with a positive skin test to common aeroallergens in the area where the clinical trial was performed were excluded from the trial. Subjects received MV130 or placebo daily for 6 months. The primary endpoint was the number of WA within 1 year after the first dose comparing MV130 and placebo. Measurements and Main Results: There was a significant lower number of WA in MV130 versus the placebo group, 3.0 (interquartile range [IQR], 2.0-4.0) versus 5.0 (IQR, 3.0-7.0) (P < 0.001). As secondary outcomes, a decrease in the duration of WA and a reduction in symptoms and medication scores in the MV130 versus placebo group were found. No adverse events were reported related to the active treatment. Conclusions: Mucosal bacterial immunotherapy with MV130 shows safety and clinical efficacy against recurrent WA in children.
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