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Study on the Safety and Immune Response of RSVPreF3 OA Vaccine with PCV20 in Adults Aged 60 and Older with RSV Disease

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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 two vaccines in adults aged 60 years and older. The diseases being studied are related to the Respiratory Syncytial Virus (RSV), which can cause respiratory infections, and infections caused by the pneumococcal bacteria, which can lead to illnesses such as pneumonia. The trial involves the use of two vaccines: the RSVPreF3 OA investigational vaccine, which is designed to protect against RSV, and the 20-valent pneumococcal conjugate vaccine (PCV20), which targets 20 different types of pneumococcal bacteria.

The purpose of the study is to evaluate the immune response, safety, and how the body reacts to these vaccines when given together compared to when they are given separately. Participants in the study will receive either both vaccines at the same time or one of the vaccines alone. The study will monitor the participants' immune responses, which are the body's defense mechanisms against infections, and any side effects that may occur after vaccination.

Throughout the study, participants will be observed for several months to assess the effectiveness of the vaccines in generating protective antibodies, which are proteins in the blood that help fight infections. The study will also track any side effects or adverse events, which are any unwanted effects that occur after vaccination. This information will help determine if the vaccines are safe and effective when administered together in older adults.

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
Joining the study
Upon joining the study, you will be asked to provide written or witnessed informed consent. This is a document that confirms your understanding and agreement to participate in the study.
You will be assessed to ensure you meet the study's inclusion criteria, such as being 60 years of age or older and being medically stable.
Step 2
First vaccination
You will receive the first dose of the RSVPreF3 OA investigational vaccine and the 20-valent pneumococcal conjugate vaccine (PCV20). These vaccines are given as a suspension for injection through an intramuscular route, which means they are injected into a muscle.
The purpose of this step is to evaluate the immune response and safety of the vaccines when given together.
Step 3
Monitoring and follow-up
After receiving the vaccines, you will be monitored for any immediate reactions. You will also be asked to keep an electronic diary (eDiary) to record any symptoms or side effects you experience.
Follow-up visits will be scheduled to assess your health and the effectiveness of the vaccines. These visits will occur at specific intervals, including one month after the vaccination to measure antibody levels.
Step 4
Final assessment
The study will conclude with a final assessment approximately six months after the last vaccination. This will include a review of your health status and any long-term effects of the vaccines.
The study aims to ensure the vaccines' safety and effectiveness in preventing diseases associated with respiratory syncytial virus (RSV) and pneumococcal infections.

Who can join the trial?

5 criteria

Must be a male or female who is 60 years of age or older at the time of the first study intervention.
Must be able to follow the study requirements, such as completing an electronic diary, attending follow-up visits, and using a phone or other electronic communication devices. If you have difficulty with these tasks, a caregiver can help you, but they cannot make health decisions for you.
Must provide written or witnessed informed consent before any study-specific procedures are performed. This means you agree to participate after understanding the study details.
Must live in the general community or in an assisted-living facility that provides minimal help, meaning you are mainly responsible for your own care and daily activities.
Must be medically stable in the opinion of the investigator at the time of the first study intervention. This means your health condition is not changing rapidly. You can have stable chronic conditions like diabetes, high blood pressure, or heart disease, as long as they are considered stable by the investigator.

Who cannot join the trial?

10 criteria

Patients who are not at least 60 years old.
Patients who have a known allergy to any component of the vaccines being studied.
Patients who have a history of severe allergic reactions, also known as anaphylaxis, to any vaccine.
Patients who have a weakened immune system, which means their body has a harder time fighting infections.
Patients who are currently participating in another clinical trial.
Patients who have received any vaccine within the last 30 days.
Patients who have a fever or any acute illness at the time of enrollment.
Patients who have a history of bleeding disorders, which means they bleed easily or have trouble stopping bleeding.
Patients who have received blood products or immunoglobulins in the last 3 months. Immunoglobulins are proteins in the blood that help fight infections.
Patients who have a history of drug or alcohol abuse within the past 2 years.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Futuremeds Sp. z o.o.
Responsive
Wroclaw, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Responsive
Cracow, Poland
Pneumocare
Responsive
Namur, Belgium

Trial locations

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Investigated drugs

RSVPreF3 OA investigational vaccine
is a vaccine being studied to help protect against respiratory syncytial virus (RSV) in older adults. RSV is a virus that can cause lung infections and breathing problems, especially in older people. This vaccine is designed to help the body build a defense against the virus by producing antibodies, which are proteins that can fight off infections.
20-valent pneumococcal conjugate vaccine (PCV20)
is a vaccine that helps protect against infections caused by pneumococcal bacteria. These bacteria can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections. The vaccine works by helping the body create antibodies to fight off these bacteria, reducing the risk of getting sick from them. In this study, the vaccine is being tested to see how well it works when given at the same time as the RSVPreF3 OA investigational vaccine.

What is already known about the treatment

RSVPreF3 OA investigational vaccine
This vaccine is administered as an injection and is currently being studied in clinical trials to assess its effectiveness and safety. It is designed to protect adults aged 60 and older from diseases caused by the respiratory syncytial virus (RSV), specifically subtypes A and B. The vaccine works by stimulating the body's immune system to produce antibodies that neutralize the virus, preventing it from causing illness. It is classified as a vaccine, which is a type of biological preparation that provides active acquired immunity to a particular infectious disease.
20-valent pneumococcal conjugate vaccine (PCV20)
This vaccine is also given as an injection and is used to protect against infections caused by 20 different types of pneumococcal bacteria. It is particularly important for older adults, as it helps prevent serious illnesses like pneumonia. The vaccine works by helping the immune system recognize and fight off the bacteria if exposed in the future. It is classified as a conjugate vaccine, which means it combines a weak antigen with a strong antigen to elicit a stronger immunological response.

Investigated diseases

Respiratory Syncytial Virus Infection – Respiratory Syncytial Virus (RSV) infection is a common respiratory virus that affects the lungs and breathing passages. It typically begins with symptoms similar to a mild cold, such as a runny nose, cough, and fever. As the infection progresses, it can lead to more severe respiratory issues, especially in older adults, such as wheezing and difficulty breathing. In some cases, it can cause bronchiolitis or pneumonia, which are more serious conditions affecting the lower respiratory tract. The virus spreads easily through respiratory droplets when an infected person coughs or sneezes. It is particularly concerning for individuals with weakened immune systems or underlying health conditions.