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Study of RSV vaccine immune response persistence and revaccination safety in adult lung and kidney transplant recipients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Respiratory Syncytial Virus (RSV) infections in adults who have received lung transplants or kidney transplants. The treatment being studied is Arexvy, which is a vaccine that helps protect against RSV. This vaccine is given as an injection into the muscle and contains parts of the virus that have been specially prepared to help the immune system recognize and fight RSV infection.

The purpose of this study is to understand how long the protection from the vaccine lasts in transplant recipients and to evaluate the effects of giving an additional dose of the vaccine. The study will follow participants who previously received either one or two doses of the vaccine in an earlier study. These participants will receive one additional dose of the vaccine and will be monitored for up to 24 months.

During the study, researchers will collect blood samples to measure the body's immune response to the vaccine. They will also monitor the participants' health and record any side effects that may occur after vaccination. The study is specifically designed for transplant recipients who are taking medications to prevent organ rejection and have stable organ function.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial vaccination visit
You will receive a single dose of Arexvy vaccine through an injection in your muscle
The vaccine contains a modified form of respiratory syncytial virus (RSV) protein and is designed to protect against RSV infections
You will need to stay at the clinic for observation after the injection
You will receive a paper diary to record any reactions for the next 7 days
Step 2
First week monitoring
Record any injection site reactions (such as pain, redness, or swelling) in your diary for 7 days
Note any general symptoms (such as fever, headache, tiredness) in your diary for 7 days
Contact medical staff if you experience any concerning symptoms
Step 3
30-day follow-up
Attend a follow-up visit for blood sample collection
Medical staff will review any health changes since vaccination
Your vaccination diary will be collected and reviewed
Step 4
6-month check
Visit the clinic for a health assessment
Provide blood samples to check your immune response
Medical staff will record any significant health events
Step 5
Long-term monitoring
Continue regular clinic visits until study end (December 2026)
Your immune response will be monitored through blood samples
Medical staff will track your overall health status
For transplant patients: regular checks of kidney or lung function will continue

Who can join the trial?

8 criteria

Must be a previous participant of the RSV OA=ADJ-023 study who received 1 or 2 doses of the RSV vaccine and has available immune response data
Must be able to follow study requirements, including: - Completing diary cards - Attending follow-up visits - Having access to phone or electronic communications - Maintaining regular contact during the study
Must provide written or witnessed informed consent before any study procedures
Female participants must be either: - Not able to have children (due to hysterectomy - removal of uterus, bilateral oophorectomy - removal of both ovaries, bilateral salpingectomy - removal of both fallopian tubes, or post-menopause), or - Using adequate birth control from 1 month before to 1 month after receiving study treatment - Have a negative pregnancy test before receiving study treatment
Must have received a compatible kidney or lung transplant more than 12 months before study treatment
Must be taking medications to prevent transplant rejection
For kidney transplant recipients: Must have stable kidney function (less than 20% variation in kidney function tests between last two measurements)
For lung transplant recipients: Must have stable lung function based on breathing tests (FEV1 - amount of air that can be forcefully exhaled in one second) compared to measurements after transplant

Who cannot join the trial?

12 criteria

Patients who have not participated in the parent study of RSV vaccine in transplant patients
People who have not received a kidney transplant or lung transplant
Individuals younger than 18 years old
Those who have known allergies to any components of the RSV vaccine
Pregnant or breastfeeding women
People who have received another vaccine within 14 days before this study
Individuals with severe allergic reactions to previous vaccinations
Those with active, uncontrolled medical conditions that could interfere with the study
People participating in other clinical trials
Individuals who have received blood products or immunoglobulins (antibodies given as medicine) within 3 months before the study
Those with a weakened immune system not related to their transplant
People with fever (temperature above 38°C/100.4°F) within 72 hours before vaccination

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Verified sites

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Responsive
Azienda Ospedaliera Universitaria Senese
Siena, Italy
Verified
Bellvitge University Hospital
L'hospitalet De Llobregat, Spain
Verified
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy

Trial locations

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Investigated drugs

RSVPreF3 vaccine This is an adjuvanted vaccine designed to protect against respiratory syncytial virus (RSV) types A and B. The vaccine works by stimulating the immune system to produce antibodies that help fight RSV infections. It's being studied specifically in people who have received kidney or lung transplants. The vaccine aims to create long-lasting protection against RSV, which can be particularly dangerous for transplant recipients due to their weakened immune systems.

Respiratory Syncytial Virus, Glycoprotein F, Recombinant, Stabilised In The Pre-Fusion Conformation, Adjuvanted With As01E

What is already known about the treatment

RSVPreF3 vaccine - An investigational vaccine administered via injection that targets Respiratory Syncytial Virus (RSV) types A and B, specifically designed for lung and kidney transplant recipients aged 18 and older. This adjuvanted vaccine is currently being studied in Phase 2b clinical trials to evaluate its ability to provide long-term immune protection and its effectiveness upon revaccination in transplant patients. The vaccine works by stimulating the immune system to produce antibodies against the RSV prefusion F protein, which is essential for the virus to enter cells, and belongs to the class of preventive viral vaccines. The addition of an adjuvant helps enhance the immune response in immunocompromised transplant recipients.

Investigated diseases

Respiratory Syncytial Virus Infections - A viral respiratory infection that affects the lungs and breathing passages. The virus enters the body through the nose or mouth, causing inflammation and swelling of the small airways (bronchioles) in the lungs. Initially, symptoms resemble a common cold with runny nose and cough, but can progress to include wheezing and difficulty breathing. The infection typically spreads through close contact with infected people or contaminated surfaces. The body usually clears the virus within a week or two, though some symptoms may persist longer. RSV infections can occur multiple times throughout life as immunity is not permanent.