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

Study Overview
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Brief Summary
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The purpose of the study is to evaluate the efficacy and safety of a biological vaccine (MV130 in subjects with Chronic Obstructive Pulmonary Disease (COPD) compared with a placebo group.

Detailed Description
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Double blind parallel placebo controlled study. The subjects will receive medication during 12 months and will be followed up during another six months

Official Title
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Randomized Double-blind Placebo-controlled Prospective, Parallel, Multicentre Clinical Trial of Bacterial Vaccine Administered by Sublingual Mucosa in Subjects With COPD for Efficacy and Safety Evaluation and Immunomodulatory Response

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Biological: Placebo
* Biological: MV130


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent. Both gender Age between 35 and 85. Must be able to follow the treatment regimen Diagnosis of moderate COPD according to GOLD criteria Consumption of 10 or more packs of cigarettes/year Fertile women of must use an approved contraceptive method Exclusion Criteria: Pregnant women, breastfeeding Subject who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion Subject with severe COPD Subject with a history of hypersensitivity to any component of the vaccine Subject outside of age range Subject diagnosed with asthma Subject who has had an exacerbation 4 weeks before starting the trial. Subject that have needed corticosteroids in the last 4 weeks before starting the trial Subject diagnosed with Primary or Secondary Immunodeficiency Subjects with chronic lymphoproliferative disease Subjects with chronic infectious disease Subject with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators. Subject diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MV130<br>The subjects will receive daily dose of MV130 during 12 months | Biological: MV130<br>* The subjects will receive daily dose of MV130 during 12 months<br>|
| Placebo Comparator: Placebo<br>The subjects will receive daily dose of placebo during 12 months | Biological: Placebo<br>* The subjects will receive daily dose of placebo during 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in the number of COP exacerbations. | Average reduction of COP exacerbations at 18 months | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of COPD exacerbations | Review of COPD exacerbations episodes severity per patient | 18 months | 
| First COPD exacerbation | When takes place the First COPD exacerbation for every single patient | 18 months | 
| Medication consumption | Review of medication consumed from the beginning to the end of the COPD exacerbation | 18 months | 
| Health resource consumption | Counting the Health resource consumption due to COPD exacerbation | 18 months | 
| Number of visits to the emergency service | Counting the number of visits to the emergency service due to COPD exacerbation | 18 months | 
| Number of hospitalizations due to COPD exacerbations | Counting the number of hospitalization days due to COPD exacerbations | 18 months | 
| Changes from baseline in COPD Assessment Test (CAT) | Compare the COPD Assessment Test results at the beginning and at the end of the trial | 18 months | 
| Changes from baseline in immunological parameters | Specific Humoral Response (Serum immunoglobulin G against the vaccine bacterial antigens; salivary immunoglobulin A concentrations versus vaccine antigens) by ELISA. Specific proliferative response of T cells (cluster of differentiation3 + / cluster of differentiation 4 + and cluster of differentiation 3 + / cluster of differentiation 8 +) in vitro following stimulation with bacterial antigens comprising the vaccine) by (carboxyfluorescein diacetate succinimidyl ester) CFSE labeling and flow cytometry. | Baseline and 12 months | 
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Review of the number of adverse event per patient | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine, Chronic obstructive pulmonary disease (COPD)