Not recruiting

Study on the Effects of Live Vaccines (Measles, Mumps, Rubella, BCG) on Immune System in Patients with Chronic Obstructive Pulmonary Disease (COPD)

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of live vaccines on patients with Chronic Obstructive Pulmonary Disease (COPD). The trial will use two types of vaccines: the M-M-RvaxPro, which is a vaccine for measles, mumps, and rubella, and the BCG Vaccine, which is used to prevent tuberculosis. These vaccines are being tested to see if they can help train the immune system in a beneficial way and reduce inflammation in the body.

The purpose of the study is to understand how these vaccines might change the immune system of people with COPD. Participants will receive either the vaccines or a saline solution, which is a simple saltwater solution used as a comparison. The study will observe changes in the immune system over a period of several months to see if the vaccines can improve the body's response to inflammation.

Throughout the study, participants will be monitored for any changes in their health, including the number of hospital visits and any worsening of COPD symptoms. The study aims to provide insights into whether these vaccines can offer additional benefits beyond their traditional uses, potentially leading to new ways to manage COPD.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Enrollment in the study requires confirmation of chronic obstructive pulmonary disease (COPD) through specialist verification and spirometry testing.
Participants must be over 40 years of age and able to provide informed consent.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline health status and measure the production capacity of certain proteins, known as cytokines, in the immune system.
This assessment helps to understand the current state of the immune system before any intervention.
Step 3
Vaccination
Participants receive live vaccines, including the BCG vaccine and M-M-RvaxPro, which are administered through injections.
The BCG vaccine is given as a suspension for injection, and the M-M-RvaxPro is a powder and solvent for suspension for injection.
Step 4
Follow-up assessments
Follow-up assessments occur at various intervals to monitor changes in the immune system.
These assessments measure the production capacity of cytokines such as IL-1β, IL-6, IL-10, TNF-α, and IFN-γ, which are important for understanding immune response.
Assessments are conducted from the time of inclusion up to four months post-inclusion.
Step 5
Long-term monitoring
Participants are monitored for changes in blood levels of pro-inflammatory cytokines and epigenetic markers of immune cells.
The study also tracks the number of hospital admissions, COPD exacerbations, and mortality over a 12-month period.
Changes in self-reported health and specific health questionnaires are evaluated from baseline to 12 months post-enrollment.

Who can join the trial?

3 criteria

Must have a specialist-verified, spirometry-confirmed, COPD. Spirometry is a test that measures how well your lungs are working.
Age must be over 40 years.
Must be able to give informed consent. This means you understand the study and agree to participate.

Who cannot join the trial?

10 criteria

Patients who have a history of severe allergic reactions to vaccines.
Individuals with a weakened immune system, which means their body has a harder time fighting infections.
People who are currently taking medications that suppress the immune system, making it less effective.
Participants who have received another vaccine within the last 30 days.
Individuals with a current infection or illness that requires treatment.
Women who are pregnant or breastfeeding.
Patients with a history of chronic diseases that are not well controlled, meaning their condition is not stable.
Anyone who has participated in another clinical trial within the last 30 days.
Individuals with a history of drug or alcohol abuse, which means they have used these substances in a harmful way.
People who are unable to follow the study procedures or instructions.

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Verified sites

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Verified
Gentofte Hospital
Hellerup, Denmark

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Investigated drugs

Live Vaccines are being used in this clinical trial to see if they can help improve the immune system in patients with COPD (Chronic Obstructive Pulmonary Disease). The goal is to find out if these vaccines can train the immune system to respond better and reduce inflammation in the body. This approach has shown positive results in other groups of people, and the trial aims to see if it can work similarly for those with COPD.

What is already known about the treatment

Live Vaccines – Live vaccines are administered through injection or oral routes, depending on the specific vaccine. They are currently being studied in clinical trials for their potential to induce beneficial immune responses in patients with chronic obstructive pulmonary disease (COPD). The main therapeutic indication is to reduce systemic inflammation and improve immune function in COPD patients. At the molecular level, live vaccines work by stimulating the body's immune system to recognize and fight pathogens, potentially leading to trained immunity. They are classified as immunological agents, specifically vaccines, and are well-documented in medical literature for their role in preventing infectious diseases.

Investigated diseases

Chronic Obstructive Pulmonary Disease – This is a long-term lung condition that makes it hard to breathe. It is characterized by a persistent blockage of airflow from the lungs, leading to breathing difficulties. The disease progresses slowly and is often associated with symptoms such as chronic cough, mucus production, and shortness of breath. Over time, the airways and air sacs in the lungs lose their elasticity, and the walls between many of the air sacs are destroyed. The walls of the airways become thick and inflamed, and the airways produce more mucus than usual, which can clog them. This condition is often caused by long-term exposure to irritating gases or particulate matter, most often from cigarette smoke.