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

Phase 2

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Biological: MV130; Biological: Placebo

• Registration Number: NCT01842360
• Lead Sponsor: Inmunotek S.L.

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

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-22
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Status Verified: 2022-02
• Last Update Submitted: 2022-05-04
• Last Update Posted: 2022-05-05
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MV130	MV130	The subjects will receive daily dose of MV130 during 12 months
Placebo	Placebo	The subjects will receive daily dose of placebo during 12 months

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (7)

Hospital Universitario Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario de Vic; 🇪🇸 Vic, Barcelona, Spain

Hospital de Torrejon; 🇪🇸 Torrejón de Ardoz, Madrid, Spain