AuthorisedTherapeutic use (Phase IV)Interventional

COPD-2VAX: Enhancing Protection Against Respiratory Infections Through AS01-Mediated Innate Immune Activation in High-Risk Patients

This study, called COPD-2VAX, is for people with Chronic Obstructive Pulmonary Disease (COPD). It's trying to understand how two new types of vaccines, one for pneumonia and one for RSV (a common cold-like virus), might help boost the body's natural defenses. Researchers want to see if these vaccines make the immune system, specifically certain cells and proteins, more active in fighting off respiratory infections. They will compare how the body reacts before and after vaccination to learn if these vaccines offer better protection.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Nordsjaellands Hospital

Enrolment target

Start

08 Dec 2025

Chronic Obstructive Pulmonary Disease (COPD)

What is this study about?

This study, called COPD-2VAX, is looking into how two important vaccines work in people who have a lung condition called Chronic Obstructive Pulmonary Disease, or COPD. People with COPD are often more likely to get serious chest infections, like pneumonia and RSV (Respiratory Syncytial Virus), which can make their breathing problems much worse. The aim of this study is to find out if these vaccines can help their bodies fight off these infections more effectively.

Researchers are particularly interested in how these vaccines make the body's natural defense system, called the immune system, stronger. They will be looking at specific signals and cells in the blood that show if the immune system is getting a good boost. This includes checking for a protein called interferon-gamma and looking at how certain immune cells, like Natural Killer cells, become more active after vaccination. They will also look at whether the body makes good levels of protective antibodies against pneumonia and RSV.

By carefully studying these responses, the researchers hope to understand if these new vaccines can give people with COPD better protection against common respiratory infections. This is important because reducing these infections could help people with COPD stay healthier and have fewer problems with their breathing.

Key takeaways

The study explores how vaccines boost immunity in people with COPD.
It focuses on vaccines for pneumonia and RSV infections.
Researchers will check how the body's natural defenses respond after vaccination.
The goal is to find better ways to protect people with COPD from chest infections.
Participation involves receiving a vaccine or a dummy injection and several blood tests over 6 months.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome to take part. The study is specifically looking for people who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD).

If you have other serious health conditions that might interfere with the study or affect your safety, you might not be able to participate. The study team will review your medical history carefully to make sure it's safe for you to join.

It's important to discuss with your doctor if this study is a good fit for you, especially considering your current health and any other medications you might be taking.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD)?
Are you a man or a woman?
Are you generally willing to attend study visits and have blood tests?
Are you willing to potentially receive either a vaccine or a saline (dummy) injection?

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 will receive either one of the study vaccines (for pneumonia or RSV) or a saline solution, which acts as a dummy injection. The study is designed to compare how your body reacts to these different interventions. You will have several clinic visits over a period of about six months (180 days).

During these visits, healthcare professionals will take blood samples. These samples will help researchers understand how your immune system responds to the vaccine or the dummy injection. They will specifically look at certain markers in your blood, like specialized proteins and immune cells, at different times after your injection. This will help them track your body's immune reaction, including antibody levels, to see if the vaccines are having the desired effect on your defenses.

Potential risks and benefits

Taking part in a study like this can have potential benefits, such as contributing to medical knowledge that could help people with COPD in the future. You might also receive close medical attention during the study period. However, there are potential risks, similar to any vaccine or medical procedure, such as soreness or swelling at the injection site, or feeling unwell for a short time. The study will also involve blood tests, which can cause minor discomfort. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Denmark

Common questions

What is COPD?

COPD stands for Chronic Obstructive Pulmonary Disease. It's a common lung condition that makes it difficult to breathe.

What is RSV?

RSV is Respiratory Syncytial Virus, a common virus that usually causes mild, cold-like symptoms, but can be more serious for people with lung conditions like COPD.

What are these vaccines for?

The study is looking at vaccines for pneumonia and RSV. These infections can be very serious for people with COPD.

What is a 'pre-filled syringe'?

It simply means the vaccine is already in the syringe, ready to be given, which makes it safer and easier for medical staff.

How long will the study last if I join?

Your participation in the study will involve follow-up and monitoring for about 180 days, or roughly 6 months.