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+

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What is this study about?

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.

1 joining the study

Upon joining the study, you will be required to provide written or witnessed informed consent. This ensures that you understand the study and agree to participate.

You will be assessed to confirm that you meet the inclusion criteria, such as being 18 years or older for transplant recipients or 50 years or older for healthy participants.

2 first vaccination

You will receive the first dose of the RSV vaccine through an injection into the muscle. This vaccine is designed to help your body build protection against the respiratory syncytial virus.

After receiving the vaccine, you will be monitored for any immediate reactions. You will also be asked to record any symptoms or side effects in a diary for the next 7 days.

3 follow-up visit 1

A follow-up visit will be scheduled to assess your health and the immune response to the first dose of the vaccine.

During this visit, blood samples may be taken to measure your body’s response to the vaccine.

4 second vaccination (for some participants)

If you are part of the group receiving two doses, you will receive a second dose of the RSV vaccine through an injection into the muscle.

Similar to the first dose, you will be monitored for any immediate reactions and asked to record any symptoms or side effects in a diary for the next 7 days.

5 follow-up visit 2

Another follow-up visit will be scheduled to assess your health and the immune response to the second dose of the vaccine, if applicable.

Blood samples may be taken again to measure your body’s response to the vaccine.

6 final follow-up visits

Additional follow-up visits will be scheduled to continue monitoring your health and the long-term immune response to the vaccine.

These visits will help gather important information about the safety and effectiveness of the vaccine over time.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Clinico San Carlos	Madrid	Spain
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
Westpfalz-Klinikum GmbH	Kaiserslautern	Germany
Istituto Mediterraneo Per I Trapianti E Terapie Ad Alta Specializzazione S.r.l.	Palermo	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Justus-Liebig-Universitaet Giessen	Giessen	Germany
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Unfqzkjpdgndruzgyvxhy Ezbay Ahk	Essen	Germany
Adfhsqs Ocoazgjpwmc Uhliaafrimtti Sqjfod	Siena	Italy
Hmqirvqz Utiptqufasuej Mtkeipf Dq Vnfafvlwdt	Santander	Spain
Hztdfdfy Ufczfvnvlyhyh dq A Cwgbtj	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	07.11.2023
Italy	Not recruiting	07.11.2023
Spain	Not recruiting	07.11.2023

Trial locations

Investigated drugs:

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

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.

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 ID:

2023-503951-81-00

Protocol code:

219900

NCT ID:

NCT05921903

Trial Phase:

Therapeutic exploratory (Phase II)

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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+

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?