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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01842360
• Other study ID #: MV130-SLG-001
• Secondary ID: 2012-003253-28
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: April 2013
• Est. completion date: March 2023

Study information

• Verified date: February 2022
• Source: Inmunotek S.L.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 180
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Infanta Leonor	Madrid
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital de Torrejon	Torrejón de Ardoz	Madrid
Spain	Hospital Universitario de Vic	Vic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Inmunotek S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in the number of COP exacerbations.	Average reduction of COP exacerbations at 18 months	18 months
Secondary	Severity of COPD exacerbations	Review of COPD exacerbations episodes severity per patient	18 months
Secondary	First COPD exacerbation	When takes place the First COPD exacerbation for every single patient	18 months
Secondary	Medication consumption	Review of medication consumed from the beginning to the end of the COPD exacerbation	18 months
Secondary	Health resource consumption	Counting the Health resource consumption due to COPD exacerbation	18 months
Secondary	Number of visits to the emergency service	Counting the number of visits to the emergency service due to COPD exacerbation	18 months
Secondary	Number of hospitalizations due to COPD exacerbations	Counting the number of hospitalization days due to COPD exacerbations	18 months
Secondary	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
Secondary	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
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Review of the number of adverse event per patient	18 months