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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Active
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Placebo
MV130
Sponsored by
Inmunotek S.L.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Vaccine, Chronic obstructive pulmonary disease (COPD)

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitario de Vic
  • Hospital de Torrejon
  • Hospital General Universitario Gregorio Marañón
  • Hospital Universitario Infanta Leonor
  • Hospital Clínico San Carlos
  • Hospital Universitario 12 de Octubre
  • Hospital Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MV130

Placebo

Arm Description

The subjects will receive daily dose of MV130 during 12 months

The subjects will receive daily dose of placebo during 12 months

Outcomes

Primary Outcome Measures

Decrease in the number of COP exacerbations.
Average reduction of COP exacerbations at 18 months

Secondary Outcome Measures

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

Full Information

First Posted
April 22, 2013
Last Updated
May 4, 2022
Sponsor
Inmunotek S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT01842360
Brief Title
Evaluation of the Efficacy and Safety of MV130 in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
MV130
Official Title
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
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2013 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inmunotek S.L.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Vaccine, Chronic obstructive pulmonary disease (COPD)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MV130
Arm Type
Experimental
Arm Description
The subjects will receive daily dose of MV130 during 12 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The subjects will receive daily dose of placebo during 12 months
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
The subjects will receive daily dose of placebo during 12 months
Intervention Type
Biological
Intervention Name(s)
MV130
Intervention Description
The subjects will receive daily dose of MV130 during 12 months
Primary Outcome Measure Information:
Title
Decrease in the number of COP exacerbations.
Description
Average reduction of COP exacerbations at 18 months
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Severity of COPD exacerbations
Description
Review of COPD exacerbations episodes severity per patient
Time Frame
18 months
Title
First COPD exacerbation
Description
When takes place the First COPD exacerbation for every single patient
Time Frame
18 months
Title
Medication consumption
Description
Review of medication consumed from the beginning to the end of the COPD exacerbation
Time Frame
18 months
Title
Health resource consumption
Description
Counting the Health resource consumption due to COPD exacerbation
Time Frame
18 months
Title
Number of visits to the emergency service
Description
Counting the number of visits to the emergency service due to COPD exacerbation
Time Frame
18 months
Title
Number of hospitalizations due to COPD exacerbations
Description
Counting the number of hospitalization days due to COPD exacerbations
Time Frame
18 months
Title
Changes from baseline in COPD Assessment Test (CAT)
Description
Compare the COPD Assessment Test results at the beginning and at the end of the trial
Time Frame
18 months
Title
Changes from baseline in immunological parameters
Description
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.
Time Frame
Baseline and 12 months
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Review of the number of adverse event per patient
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo Fernández-Cruz, MD-PhD-prof
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Javier Miguel Díez, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José Luis Alvarez-Salas, MD-PhD-prof,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
María Jesús Buendía, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos José Álvarez, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soledad Alonso, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francisco García, MD
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joan Serra, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de Vic
City
Vic
State/Province
Barcelona
ZIP/Postal Code
08500
Country
Spain
Facility Name
Hospital de Torrejon
City
Torrejón de Ardoz
State/Province
Madrid
ZIP/Postal Code
28850
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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