Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Using live vaccines to induce beneficial innate immune training and reduce systemic inflammation in COPD patients (COPD-LIVE)

The COPD-LIVE study is investigating if certain live vaccines, which are commonly used, can help train the body's initial defense system, called the innate immune system, in people living with Chronic Obstructive Pulmonary Disease (COPD). The main goal is to see if these vaccines can reduce inflammation throughout the body. Researchers will measure changes in crucial signaling proteins (cytokines) involved in inflammation over four months. They will also track important health markers like hospital visits, COPD flare-ups, and changes in how patients feel and their ability to breathe over a year. This is a Phase II study, meaning it's an early-stage trial exploring whether this approach might be effective.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Gentofte Hospital, Gentofte Hospital

Enrolment target

Start

11 Dec 2023

Chronic obstructive pulmonary disease

What is this study about?

This research, called COPD-LIVE, is investigating a new way to potentially help people with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung condition that makes it hard to breathe, often due to inflammation in the lungs. Scientists are looking into whether giving certain live vaccines, which are already used for other purposes, could help 'train' the body's natural first line of defence, known as the innate immune system.

The idea is that by boosting or 'training' this immune system, it might become better at reducing general inflammation throughout the body. We know that ongoing inflammation can make COPD worse, so finding ways to lessen it could be very helpful. This study will carefully examine how the body's immune cells respond after vaccination and measure changes in important chemical signals that control inflammation.

Ultimately, researchers hope to see if these vaccines could lead to fewer serious COPD flare-ups, fewer hospital stays, and an overall improvement in a person's health and quality of life over time. This is an exploratory study, meaning it's an early step to see if this approach is promising and worth further investigation.

Key takeaways

This study explores if vaccines can help manage inflammation in COPD.
It uses existing vaccines like MMR and BCG.
Researchers will monitor immune responses and key health changes over time.
It's open to adults aged 18 and over, both men and women.
Participation involves clinic visits, blood tests, and health questionnaires over a year.

Who may be eligible?

To be considered for the COPD-LIVE study, participants must be adults, aged 18 years or older. There is no upper age limit for joining.

Both men and women are welcome to take part in this research.

Full details about other health conditions, medications, or lifestyle factors that might affect your eligibility would be discussed with the study team. This typically includes ensuring your general health is stable enough to safely participate.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of COPD?
Are you able to attend clinic visits regularly?
Are you comfortable with blood tests and injections?
Are you a man or a woman?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive one of the study treatments: either a live measles, mumps, and rubella (MMR) vaccine, a BCG vaccine, or a saline (saltwater) injection, which acts as a comparison. You would have several visits to the clinic where study staff will take blood samples to check your body's immune response and inflammation levels. You'll also likely complete questionnaires about your breathing and general health. The main part of the study involves monitoring changes over the first four months after your treatment. However, researchers will continue to track your health, including any hospital admissions or COPD flare-ups, for a full 12 months. The research team will explain the exact schedule of visits and assessments.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving close medical attention for your condition and contributing to scientific knowledge that could help others with COPD in the future. However, there are also potential risks involved. The vaccines used in this study, though generally safe, can have side effects similar to routine vaccinations, such as a sore arm, fever, or mild rash. There is no guarantee that the treatment will be effective for you. You have the right to withdraw from the study at any time for any reason, without it affecting your usual medical care.

Locations (1)

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Denmark

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that causes breathing difficulties, often due to ongoing inflammation in the lungs.

What are "live vaccines"?

Live vaccines contain a weakened form of a virus or bacteria. They work by teaching your immune system to fight off future infections. Examples include the MMR and BCG vaccines.

What is "innate immune training"?

This refers to the idea that certain vaccines might improve how your body's initial defence (innate immune system) responds to future threats, potentially helping to reduce inflammation.

Will I know which treatment I receive?

In this type of study, participants are usually 'blinded,' meaning you won't know if you're getting an active vaccine or the saline injection. This helps ensure fair and unbiased results.

How long will I be involved in the study?

While the main measurements happen over four months, your health will be tracked for a full year after you join the study.