Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD)

NCT01842360 | Completed Phase 2 Results

• 2 other identifiers: MV130-SLG-0012012-003253-28
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 7

Brief Summary

The goal of this clinical trial is to learn whether the bacterial vaccine MV130 helps reduce the number of exacerbations in adults with moderate to severe COPD. It will also assess the safety and immune effects of MV130. The main questions it aims to answer is: Does MV130 lower the number and severity of COPD flare-ups? Other questions include: Does it reduce the use of healthcare resources and improve quality of life? Researchers will compare MV130 to a placebo (a similar spray without the active substance; bacterial species) to see how well it works. Participants will use either MV130 or placebo daily under the tongue for 12 months, attend regular clinic visits, and be followed for an additional 6 months to monitor health outcomes and side effects.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Vaccine; Chronic obstructive pulmonary disease (COPD); Exacerbations; Prevention; Sublingual

Outcome Measures

Primary Outcomes (1)

• Number of COPD Exacerbations.

  Comparison in the number of COPD exacerbations in the two study groups in the 18-month study period.

  18 months

Secondary Outcomes (11)

• Change in the Rate of COPD Exacerbations.

  18 months

• Change in Severity of COPD Exacerbations.

  18 months

• Time Elapsed Between Start of Treatment and First COPD Exacerbation.

  18 months

• Use of Drugs (Antibiotics, Corticosteroids, Etc).

  18 months

• Number of Hospitalizations Due to a COPD Exacerbation.

  18 months

Study Arms (2)

Active - MV130

EXPERIMENTAL

The participants will receive daily dose of MV130 during 12 months sublingually.

Biological: MV130

Placebo

PLACEBO COMPARATOR

The participants will receive daily dose of placebo during 12 months sublingually.

Biological: Placebo

Interventions

Placebo BIOLOGICAL

The participants will receive daily dose of placebo during 12 months sublingually.

Placebo

MV130 BIOLOGICAL

The participants will receive daily dose of MV130 during 12 months sublingually.

Active - MV130

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Both sexes.
• Age between 35 and 85.
• Must be capable of complying with the dosing regimen.
• Diagnosis of moderate or severe COPD according to GOLD criteria.
• Experienced at least three moderate exacerbations (i.e., those requiring treatment with antibiotics, systemic corticosteroids, or both, as prescribed by their general practitioner or pulmonologist in the standard consultation and/or the Emergency Department of their Clinic) or two exacerbations with at least one requiring hospitalization due to a COPD exacerbation and the other one a moderate exacerbation occurred within the last year.
• Not changed their medication for the maintenance treatment of COPD within the past 6 months.
• Consumption of 10 or more packs of cigarettes/year. Participants may be or not active smokers.
• Live in the Autonomous Community of Madrid throughout the study period.
• Women of childbearing age women of must use an approved contraceptive method and obtain a negative result in the urine pregnancy test performed during the screening visit.

You may not qualify if:

• Participants outside allowed age range.
• Participants unable to cooperate and/or have a severe psychiatric disorder.
• Women who are pregnant, breastfeeding, expect to become pregnant during the study (including assisted reproduction), or who refuse to use contraceptives during the study (including barrier methods). Women who become pregnant during the clinical trial will have to discontinue their participation in it.
• Participants diagnosed with asthma based on the guidelines of the American Thoracic Society and the European Respiratory Society. If the investigators are unable to differentiate between COPD and asthma after applying the criteria listed in the following table, a bronchodilator test with inhaled salbutamol must be performed, excluding those subjects with FEV1 changes \>400 ml.
• Participants with a diagnosis other than COPD that causes them to have an unstable condition or a life expectancy \<3 years.
• Participants who had an exacerbation within 4 weeks before starting the trial.
• Participants with moderate COPD who required treatment with inhaled corticosteroids in the last 4 weeks.
• Participants with moderate COPD who received systemic corticosteroids (orally, intramuscularly, or intravenously) in the last 4 weeks.
• Participants diagnosed with chronic lymphoproliferative disease.
• Participants diagnosed with chronic infectious disease.
• Participants with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators.
• Participants diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa.
• Participants with COPD and bronchiectasis diagnosed by CT imaging before the age of 40.
• Participants diagnosed with very severe COPD according to the GOLD classification.
• Participants requiring home oxygen therapy or non-invasive mechanical ventilation.

Sponsors & Collaborators

• Inmunotek S.L.: lead

Study Sites (7)

Hospital Universitario de Vic

Vic, Barcelona, 08500, Spain

Location

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, 28850, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Miguel Casanovas
• Organization: Inmunotek S.L

mcasanovas@inmunotek.com

34691490175

Study Officials

• Eduardo Fernández Cruz, MD, PhD

  Hospital General Universitario Gregorio Marañón

  STUDY DIRECTOR

• Javier de Miguel Díez, MD, PhD

  Hospital General Universitario Gregorio Marañón

  PRINCIPAL INVESTIGATOR

• José Luis Álvarez-Sala, MD, PhD

  Hospital San Carlos, Madrid

  PRINCIPAL INVESTIGATOR

• María J Buendía, MD

  Hospital Universitario Infanta Leonor

  PRINCIPAL INVESTIGATOR

• Carlos J Álvarez, MD, PhD

  Hospital Universitario 12 de Octubre

  PRINCIPAL INVESTIGATOR

• Soledad Alonso, MD

  Hospital Universitario de Torrejón,Madrid

  PRINCIPAL INVESTIGATOR

• Francisco García, MD, PhD

  Hospital Universitario La Paz

  PRINCIPAL INVESTIGATOR

• Joan Serra, MD

  Hospital de Universitario Vic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: April 29, 2013
• Study Start: May 6, 2013
• Primary Completion: July 29, 2019
• Study Completion: August 2, 2023
• Last Updated: October 2, 2025
• Results First Posted: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7)