Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in Children: A Randomized, Double-blind, Placebo-controlled Trial.

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 a 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 positive skin test to common aeroallergens in the area where the clinical trial was carried out were excluded from the trial. Subjects received MV130 or placebo daily for 6 months. The primary endpoint was the number of WA within one year after the first dose comparing MV130 and placebo. MEASUREMENTS AND MAIN RESULTS There was a significant lower number of WA in MV130 vs placebo group, 3.0 [IQR, 2.0 - 4.0] vs 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 MV130 vs 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. Clinical trial registration available at www.clinicaltrials.gov, ID: NCT01734811.