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

Randomized Double-blind Placebo-controlled Multicenter Clinical Trial of Bacterial Polyvalent Vaccine (BACTEK®), Administered Sublingually in COPD Patients, to Evaluate Efficacy, Safety, and Immunomodulatory Response.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Biological: MV130; Biological: Placebo

Detailed Description

This was a randomized, double-blind, placebo-controlled, prospective, parallel, multicenter clinical trial designed to evaluate the efficacy, safety, and immunomodulatory effects of a sublingually administered bacterial polyvalent vaccine (BACTEK®, also known as MV130) in adult participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The study was conducted by Inmunotek, S.L., and included seven sHospitals across Spain. A total of 198 participants were enrolled and randomized equally into two groups to receive either MV130 or placebo over a period of 12 months, followed by a 6-month observation phase, totaling 18 months of participation per participant.

The investigational product, MV130, consisted of a glycerinated suspension containing six inactivated non-lysate bacterial species: Streptococcus pneumoniae, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae, Moraxella catarrhalis, and Haemophilus influenzae. The product was administered sublingually at a dosage of two sprays (0.2 mL total) per day. The placebo formulation was identical in appearance and composition, excluding the active bacterial components. All study participants received their first dose under supervision at the clinical site and were trained for home administration.

Eligible participants were between 35 and 85 years old, with a diagnosis of moderate or severe COPD according to GOLD guidelines, a history of recurrent exacerbations (≥3 moderate or ≥2 with at least one hospitalization in the past year), and a smoking history of at least 10 pack-years. Subjects were excluded if they had very severe COPD, a history of recent exacerbations or systemic corticosteroid use, concurrent immunodeficiency or serious comorbid conditions, or if they were pregnant, breastfeeding, or unwilling to use contraception during the study.

The primary efficacy endpoint was the total number of COPD exacerbations during the full 18-month period. Secondary endpoints included the severity of exacerbations, time to first exacerbation, healthcare resource usage (hospitalizations, emergency room visits, unscheduled consultations), medication use, health-related quality of life (assessed using the CAT questionnaire), and a pharmacoeconomic evaluation based on healthcare expenditures. In a subset of participants, immunological parameters were also assessed to explore the immunomodulatory response. Safety analysis included all randomized participants.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Clinico San Carlos
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañon
  • Madrid, Spain, 28031
    • Hospital Universitario Infanta Leonor
  • Barcelona
    • Vic, Barcelona, Spain, 08500
      • Hospital Universitario de Vic
  • Madrid
    • Torrejón de Ardoz, Madrid, Spain, 28850
      • Hospital Universitario de Torrejón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion.
• 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 a Primary or Secondary Immunodeficiency within the 12 months preceding their inclusion in the clinical trial or the trial's baseline visit.
• 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.
• Participants with a history of hypersensitivity to any of the vaccine's components.
• Participants receiving immunosuppressive treatment with: azathioprine, methotrexate, ciclosporin, cyclophosphamide, tacrolimus, antimalarial drugs, or gold salts.
• Participants who have been treated with monoclonal antibodies such as rituximab or TNF-alpha inhibitors in the last 6 months.
• Participants receiving chronic treatment with azithromycin or inhaled antibiotics (tobramycin or colistin).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active - MV130; The participants will receive daily dose of MV130 during 12 months sublingually.	Biological: MV130; The participants will receive daily dose of MV130 during 12 months sublingually.
Placebo Comparator: Placebo; The participants will receive daily dose of placebo during 12 months sublingually.	Biological: Placebo; The participants will receive daily dose of placebo during 12 months sublingually.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Rate of COPD Exacerbations.	Incidence is the number of new events per total participants in the sample population.	18 months
Change in Severity of COPD Exacerbations.	The severity of exacerbations was to be measured by the consumption of health care resources: Emergency Department/Hospitalisation/Intensive Care Unit/Consultations visits, as follows: ICU hospitalisation 4 points Hospitalisation 3 points Emergency room visit 2 points Consultation resulting in change in usual treatment 1 point	18 months
Time Elapsed Between Start of Treatment and First COPD Exacerbation.	For reference, median survival or event-free times are reported with the 95% CI of the median.	18 months
Use of Drugs (Antibiotics, Corticosteroids, Etc).	The use of drugs will be calculated using the following index: antibiotics: 1 point; inhaled corticosteroids: 2 points; systemic corticosteroids: 3 points	18 months
Number of Hospitalizations Due to a COPD Exacerbation.	The same patient could have more than one hospitalizations.	18 months
Days of Hospitalization Due to a COPD Exacerbation.	Number of days of hospitalization per patient were recorded. The same patient could have more than one hospitalization.	18 months
Number of Visits to the Emergency Room.	Number of individual visits were recorded per patient. One patient could have multiple visits.	18 months
Number of Unscheduled Medical Consultations Due to COPD	Number of consultations per patient. One patient could have multiple consultations.	18 months.
Health Related Quality of Life.	COPD Assessment Test per patient determined by an adapted version of the specific COPD Assessment Test. Minimum value is 0 (better) and maximum value is 40 (worse). The change between two or more time points is reported. Change between baseline and 18 months in shown.	18 months
Healthcare Resource Utilization During COPD Exacerbations	Healthcare resource utilization was assessed as the sum of: Complementary tests; Programmed visits to the specialist; Total number of visits to the specialist; Non-programmed visits to the specialist; ICU hospitalization days; Visits to the emergency room; Days hospitalized; Sum of antibiotics; Number of visits to General Practitioner; Sum of oral corticosteroids; Number of telephone calls to the GP; Sum of inhalers; Home visits; Sum of antipyretics Total number of healthcare resources used during COPD exacerbation episodes. Data were summarized per treatment group and reported as total counts and percent differences. No baseline or monetary data were collected	18 months
Adverse Events and Overall Tolerability (Adverse Reactions).	Total number of adverse events in Active (MV130) and Placebo groups were compared.	18 months

Collaborators and Investigators

• Sponsor: Inmunotek S.L.
• Investigators: Study Director: Eduardo Fernández Cruz, MD, PhD, Hospital General Universitario Gregorio Marañon; Principal Investigator: Javier de Miguel Díez, MD, PhD, Hospital General Universitario Gregorio Marañon; 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

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2013
• Primary Completion (Actual): July 29, 2019
• Study Completion (Actual): August 2, 2023

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: April 24, 2013
• First Posted (Estimated): April 29, 2013

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Vaccine; Prevention; Exacerbations; Chronic obstructive pulmonary disease (COPD); Sublingual
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: MV130-SLG-001; 2012-003253-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No