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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: March 2023

Detailed Description

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

Interventions

  • Biological: Placebo
    • The subjects will receive daily dose of placebo during 12 months
  • Biological: MV130
    • The subjects will receive daily dose of MV130 during 12 months

Arms, Groups and Cohorts

  • Experimental: MV130
    • The subjects will receive daily dose of MV130 during 12 months
  • Placebo Comparator: Placebo
    • The subjects will receive daily dose of placebo during 12 months

Clinical Trial Outcome Measures

Primary Measures

  • Decrease in the number of COP exacerbations.
    • Time Frame: 18 months
    • Average reduction of COP exacerbations at 18 months

Secondary Measures

  • Severity of COPD exacerbations
    • Time Frame: 18 months
    • Review of COPD exacerbations episodes severity per patient
  • First COPD exacerbation
    • Time Frame: 18 months
    • When takes place the First COPD exacerbation for every single patient
  • Medication consumption
    • Time Frame: 18 months
    • Review of medication consumed from the beginning to the end of the COPD exacerbation
  • Health resource consumption
    • Time Frame: 18 months
    • Counting the Health resource consumption due to COPD exacerbation
  • Number of visits to the emergency service
    • Time Frame: 18 months
    • Counting the number of visits to the emergency service due to COPD exacerbation
  • Number of hospitalizations due to COPD exacerbations
    • Time Frame: 18 months
    • Counting the number of hospitalization days due to COPD exacerbations
  • Changes from baseline in COPD Assessment Test (CAT)
    • Time Frame: 18 months
    • Compare the COPD Assessment Test results at the beginning and at the end of the trial
  • Changes from baseline in immunological parameters
    • Time Frame: Baseline and 12 months
    • 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.
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    • Time Frame: 18 months
    • Review of the number of adverse event per patient

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Inmunotek S.L.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eduardo Fernández-Cruz, MD-PhD-prof, Study Director,
    • Javier Miguel Díez, MD, Principal Investigator,
    • José Luis Alvarez-Salas, MD-PhD-prof,, Principal Investigator,
    • María Jesús Buendía, MD, Principal Investigator,
    • Carlos José Álvarez, MD, Principal Investigator,
    • Soledad Alonso, MD, Principal Investigator,
    • Francisco García, MD, Principal Investigator,
    • Joan Serra, MD, Principal Investigator,

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