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Study of RSV vaccine and pneumococcal vaccine combination for patients aged 60 and older with chronic obstructive pulmonary disease

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 study involves people with Chronic Obstructive Pulmonary Disease, which is a long-term lung condition that makes breathing difficult and affects the airways. The study will test two vaccines that protect against different types of infections that can affect the lungs. The first vaccine is Arexvy, which protects against Respiratory Syncytial Virus, a common virus that can cause serious breathing problems, especially in older adults and people with lung disease. The second vaccine is Prevenar 20, which protects against bacteria called pneumococcus that can cause lung infections and other serious illnesses. The study will also use a placebo, which is a substance that looks like the vaccine but contains no active ingredients.

The purpose of the study is to find out if the Arexvy vaccine can strengthen the body's natural defense system in people with lung disease who are at higher risk for severe breathing infections. The researchers want to see if giving Arexvy can help the body respond better to the Prevenar 20 vaccine when they are given at the same time or close together. They will also look at whether Arexvy provides broader protection against various breathing infections and helps control viruses that may stay in the body for a long time.

Participants in this study will receive injections of the vaccines in their arm muscle. Some people will get both vaccines at the same time, while others will receive them at different times. The study will involve blood sample collections at different time points to measure how well the immune system, which is the body's defense against infections, responds to the vaccines. The researchers will look at specific markers in the blood that show how active the immune system is and measure the levels of protective proteins called antibodies that the body makes after vaccination. The study will follow participants for several months after they receive the vaccines to see how long the protection lasts.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial vaccination visit
On the first day of the trial, blood samples will be collected before receiving any vaccines. This baseline sample allows for comparison with later results.
You will receive vaccines on this day. The specific vaccines and their administration will depend on the group you are assigned to.
One vaccine contains a respiratory syncytial virus component, which is a virus that can cause respiratory infections. This vaccine also contains an adjuvant called AS01E, which is a substance that helps strengthen the body's immune response.
Another vaccine is Prevenar 20, which protects against 20 types of pneumococcal bacteria that can cause serious infections.
A third option is saline, which is a salt water solution used as a comparison.
All vaccines are given as intramuscular injections, meaning they are injected into a muscle.
The vaccines may be given in the same arm or in opposite arms, depending on the study group assignment.
Step 2
Follow-up visit 24 hours after vaccination
Blood samples will be collected 24 hours after receiving the vaccines.
These samples will be used to measure interferon-gamma, which is a protein that indicates immune system activation.
The samples will also be analyzed for Natural Killer cell activation. Natural Killer cells are a type of white blood cell that helps fight infections.
Laboratory tests will examine specific genes related to the interferon response, which is part of the body's defense against viruses.
This visit helps determine how the immune system responds in the first day after vaccination.
Step 3
Follow-up visit 30 days after vaccination
Blood samples will be collected 30 days after the initial vaccination.
These samples will measure antibody levels against pneumococcal bacteria. Antibodies are proteins produced by the immune system to fight infections.
The laboratory will test for antibodies against 12 specific types of pneumococcal bacteria included in the Prevenar 20 vaccine.
Tests will assess the functional activity of these antibodies, meaning how well they can actually fight bacteria, not just whether they are present.
The samples will also be analyzed for RSV antibodies, which are antibodies against respiratory syncytial virus.
Additional tests will measure CD4+ T-cell responses. CD4+ T-cells are white blood cells that help coordinate the immune response.
Laboratory analysis will examine how these T-cells produce specific proteins when exposed to RSV and pneumococcal components.
Step 4
Follow-up visit 180 days after vaccination
Blood samples will be collected 180 days after the initial vaccination.
The same types of antibody measurements performed at 30 days will be repeated to assess how long the immune protection lasts.
This includes measuring pneumococcal antibody levels and their functional activity against bacteria.
RSV antibody levels will also be measured again to determine if protection against respiratory syncytial virus is maintained.
Analysis of antibody structure will be performed to understand how the antibodies may have changed over time.
This final visit completes the main observation period of the trial.

Who can join the trial?

4 criteria

You must have a confirmed diagnosis of COPD, which stands for Chronic Obstructive Pulmonary Disease, a lung condition that makes breathing difficult. This diagnosis must be made by a lung specialist and you must be receiving care at the hospital's outpatient clinic.
You must be 60 years of age or older.
You must have received the PPV23 vaccine, which is a pneumonia vaccine, more than one year before joining this study.
You must agree to take part in all parts of the trial and sign the informed consent form, which is a document that explains the study and confirms your agreement to participate.

Who cannot join the trial?

11 criteria

You are younger than 60 years old
You do not have COPD, which is a lung disease that makes breathing difficult and blocks airflow
You have a severe illness or medical condition that would make it unsafe for you to participate in the study
You have a known allergy or severe reaction to any component of the vaccines being tested
You have received certain vaccines recently that could interfere with the study results
You have a weakened immune system due to disease or medications, such as treatments for cancer or conditions requiring immune-suppressing drugs
You are pregnant or planning to become pregnant during the study period
You have received blood products or immunoglobulins, which are proteins that help fight infections, within a specific time before the study
You have an active infection or fever at the time of vaccination
You are participating in another clinical trial that could affect the results of this study
You have any condition that, in the opinion of the study doctor, would make it difficult for you to complete the study or could put your health at risk

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Hillerod Hospital
Hillerød, Denmark

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Investigated drugs

AS01-adjuvanted RSV vaccine
is a vaccine designed to protect against respiratory syncytial virus (RSV), which is a common virus that can cause serious breathing problems. This vaccine contains a special ingredient called AS01 that helps boost the body's immune system to fight infections more effectively. In this study, researchers want to see how well this vaccine works in people with chronic lung disease and whether it can provide protection not only against RSV but also help the immune system respond better to other infections.
PCV20
is a pneumococcal vaccine that protects against 20 different types of bacteria that can cause pneumonia, meningitis, and other serious infections. Pneumococcal bacteria are particularly dangerous for older adults and people with lung conditions. In this study, this vaccine will be given together with the RSV vaccine to see if combining them improves the body's ability to fight pneumococcal infections.

What is already known about the treatment

AS01-adjuvanted RSV vaccine
This is an investigational vaccine designed to protect against respiratory syncytial virus (RSV) infections, administered through injection and enhanced with a special ingredient called AS01 that helps boost the body's immune response. The vaccine is currently being studied in clinical trials specifically for patients with chronic obstructive pulmonary disease (COPD) who are 60 years of age or older and are at high risk for severe respiratory infections. It works by activating both the immediate defense system of the body (innate immunity) and the long-term protective response (adaptive immunity) at the cellular level, creating protection in both the respiratory tract and throughout the body. This vaccine belongs to the class of adjuvanted vaccines, meaning it contains additional components that strengthen the immune system's ability to recognize and fight off RSV infections.
PCV20
This is a pneumococcal conjugate vaccine that protects against 20 different types of bacteria called Streptococcus pneumoniae, which can cause serious infections like pneumonia, meningitis, and bloodstream infections, administered as an injection. The vaccine is already approved and widely used in medical practice for preventing pneumococcal diseases in adults, particularly those at increased risk due to age or underlying health conditions. In this clinical trial, it is being given together with the RSV vaccine to study whether the combination approach can enhance the immune response and provide better protection against bacterial respiratory infections in COPD patients. The vaccine works by introducing harmless pieces of the pneumococcal bacteria's outer coating attached to a carrier protein, which trains the immune system to recognize and attack these bacteria if encountered in the future.

Investigated diseases

Chronic Obstructive Pulmonary Disease – Chronic Obstructive Pulmonary Disease is a long-term lung condition that makes it difficult to breathe. The disease develops when the airways in the lungs become narrowed and the air sacs are damaged. This damage is usually caused by long-term exposure to irritating gases or particles, most often from cigarette smoke. As the disease progresses, patients experience increasing shortness of breath, frequent coughing, and chest tightness. The airflow limitation becomes progressively worse over time, making everyday activities more challenging. The disease typically affects people aged 40 years and older, particularly those with a history of smoking or exposure to air pollution.