Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Not recruiting
Study on the Immune Response and Safety of RSVPreF3 Vaccine in Adults 18+ with Lung or Kidney Transplants at Risk of RSV Infections, Compared to Healthy Adults 50+
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
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 a vaccine for Respiratory Syncytial Virus (RSV), a virus that can cause infections in the lungs and breathing passages. The vaccine being tested is called Arexvy, which is a powder and suspension for injection. It is designed to help the body build a defense against RSV by using a special protein from the virus that is stabilized and combined with an ingredient to boost the immune response.
The purpose of the study is to evaluate how well the vaccine works and how safe it is for adults who have received a lung or kidney transplant, as they are at a higher risk of severe RSV infections. The study will also include healthy adults aged 50 and above for comparison. Participants will receive either one or two doses of the vaccine, and their immune response will be monitored to see how their bodies react to the vaccine.
Throughout the study, participants will be observed for any side effects and how their immune systems respond to the vaccine. The study aims to gather information on the vaccine's ability to protect against RSV and ensure it is safe for use in people with different health conditions. This research is important for developing effective vaccines to prevent RSV infections, especially in those who are more vulnerable due to their health status.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
11 criteria
- Participants and/or their parent(s) or legally authorized representative(s) must be able to follow the study requirements, such as filling out diary cards, attending follow-up visits, and using a phone or electronic communication.
- Participants should live in the community or in a facility that provides minimal assistance, meaning they can mostly take care of themselves.
- Participants must provide written or witnessed informed consent, which means they understand and agree to the study procedures.
- Female participants who cannot have children can join the study. This includes women who have had a hysterectomy (removal of the uterus), bilateral oophorectomy (removal of both ovaries), bilateral salpingectomy (removal of both fallopian tubes), or are post-menopausal (have stopped having periods).
- Female participants who can have children may join if they have used effective birth control for at least one month before the study and agree to continue using it during the study. They must also have a negative pregnancy test before receiving the study vaccine.
- Participants must be at least 18 years old and have received a compatible kidney or lung transplant more than 12 months ago.
- Participants must be taking medication to prevent their body from rejecting the transplanted organ.
- Kidney transplant participants must have stable kidney function, meaning their kidney function tests show less than 20% change between the last two results, or as determined by the study doctor.
- Lung transplant participants must have stable lung function, meaning their lung function tests are stable compared to their baseline after the transplant, as determined by the study doctor.
- Healthy participants must be at least 50 years old and considered healthy based on medical history and examination.
- Participants with stable chronic conditions like diabetes, high blood pressure, or heart disease can join if the study doctor considers them stable.
Who cannot join the trial?
5 criteria
- Patients who have had an organ transplant, specifically renal (kidney) or lung transplants, cannot participate.
- Patients who are part of a vulnerable population are not eligible. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
- Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
- Patients who do not meet the health requirements for the study, such as having certain medical conditions, are excluded.
- Patients who are not able to follow the study procedures or attend all required visits are not eligible.
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, SpainFundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
ResponsiveBarcelona, Spain
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
RSVPreF3 OA investigational vaccine is a vaccine being tested to see how well it helps the body fight off the respiratory syncytial virus (RSV). This virus can cause lung infections, especially in people with weakened immune systems, like those who have had lung or kidney transplants. The study is looking at how the immune system responds to the vaccine after one or two doses. The goal is to see if the vaccine can help protect these patients from getting sick with RSV. The vaccine is also being compared to how it works in healthy people who are 50 years or older. This helps researchers understand if the vaccine works differently in people with different health conditions.
What is already known about the treatment
RSVPreF3 OA investigational vaccine – This vaccine is administered through an injection and is currently being studied in clinical trials to assess its effectiveness and safety. It is designed to protect against infections caused by the Respiratory Syncytial Virus (RSV), particularly in adults who have undergone lung or kidney transplants. The vaccine works by stimulating the body's immune system to produce antibodies that target and neutralize the RSV virus. It is classified as a vaccine under pharmacological terms and is being evaluated for its ability to generate an immune response against different strains of the RSV virus.
Investigated diseases
Respiratory Syncytial Virus Infections – Respiratory Syncytial Virus (RSV) infections are caused by a virus that primarily affects the respiratory tract. The virus is highly contagious and spreads through droplets from coughs or sneezes. Infections often begin with symptoms similar to a common cold, such as a runny nose, cough, and fever. As the infection progresses, it can lead to more severe respiratory issues, especially in infants and older adults, such as bronchiolitis or pneumonia. The virus can cause inflammation and obstruction of the small airways in the lungs, leading to difficulty breathing. Recovery from the infection can vary, with symptoms typically lasting a week or two, but severe cases may require medical attention.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503951-81-00Protocol code219900Estimated enrolment375 patientsSponsorGlaxoSmithKline Biologicals
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?