Prevention of COPD exacerbations with a mucosal trained immunity-based vaccine (MV130): a randomised phase 3 trial
In brief
Sublingual MV130 cuts COPD exacerbations by 30% in frequent exacerbators
In a Spanish trial of 198 people with frequent COPD flare-ups, those taking MV130 had 1.87 exacerbations per patient-year, compared with 2.68 with placebo - about 30% fewer over 18 months. Adverse events were reported in about half of participants in each group, with only two judged possibly related to treatment; whether the benefit holds in broader COPD populations remains unknown.
- Journal
- The European respiratory journal (Q1)
- Published
- 23 July 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Luis Puente Maestu, Myriam Calle Rubio, Paola Benedetti, Walther Iván Girón Matute, Juan Luis Rodríguez Hermosa, José Luis Álvarez-Sala, et al.
- PMID
- 42492956
- DOI
- 10.1183/13993003.00027-2026
Why clinicians should know about it
- Picked for Pulmonary and Respiratory Medicine (top studies of the week, 11 October 2026): Phase 3 RCT, MV130 reduces COPD exacerbations, directly relevant to
Abstract
BACKGROUND: Respiratory infections are the primary trigger of acute exacerbations in COPD, yet preventive strategies remain limited. This study aims to evaluate the efficacy and safety of MV130, a sublingual mucosal vaccine, in preventing COPD exacerbations alongside maintenance therapy. METHODS: A phase 3, multicentre, double-blind, placebo-controlled, randomised clinical trial included 198 subjects across seven hospitals in Spain, with 1:1 allocation to MV130 or placebo. Eligible patients had ≥3 moderate COPD exacerbations or≥2 with at least one requiring hospitalisation in the previous year. Patients received MV130 (300 FTU) or placebo daily for 12 months. The primary outcome, assessed in both intention-to-treat (ITT) and per-protocol (PP) populations, was the number of exacerbations over 18 months (12 months of treatment +6 months follow-up). Secondary exploratory endpoints related to healthcare resource utilisation and medication use were also evaluated in the ITT population. Safety was also assessed in the ITT population. (ClinicalTrials.gov: NCT01842360; EudraCT: 2012-003253-28). RESULTS: Between May 2013 and January 2018, 198 eligible participants (154 men, 44 women; 97 MV130, 101 placebo) were enrolled. Baseline COPD medication use was well balanced between the treatment groups. Median number of acute exacerbations in the ITT set was 3.0 [interquartile range, IQR, 1.0-5.0] for placebo versus 2.0 [IQR, 1.0-3.0] for MV130 (p=0.001). MV130 reduced exacerbation rate from 2.68 to 1.87 events per patient-year (95% CI 0.44-1.18; p<0.001). There were 229 adverse events (AEs) reported in 103 participants (52%), 113 (48.5%) in the placebo group and 116 (55.7%) in the MV130 group. Two AEs, urticaria (placebo) and pruritus (MV130), were non-serious and assessed as possibly related to the study medication. CONCLUSION: MV130 reduces moderate and severe COPD exacerbations, suggesting its potential role as an adjunct preventive therapy.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.