Recruiting

Study on RSV Vaccination with Abrysvo and Arexvy for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

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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 vaccines for the Respiratory Syncytial Virus (RSV) in patients who have undergone allogeneic hematopoietic stem cell transplantation. This type of transplantation involves using stem cells from a donor to replace damaged or diseased bone marrow. The study will test two different vaccines: Arexvy and Abrysvo. Arexvy is a vaccine that contains a part of the RSV virus called the glycoprotein F, which is stabilized in a specific form and combined with an ingredient to boost the immune response. Abrysvo is a bivalent vaccine, meaning it targets two subgroups of the RSV virus, using stabilized proteins from each subgroup.

The purpose of the study is to evaluate how well these vaccines work in helping the immune system of transplant recipients respond to RSV. Participants will be randomly assigned to receive either the Arexvy or Abrysvo vaccine. The study will monitor the participants' immune response to the vaccine, specifically looking for a significant increase in antibodies, which are proteins the body makes to fight infections. The study will also include a group of healthy older adults to compare their immune responses to those of the transplant recipients.

Participants will receive the vaccine through an intramuscular injection, which means it will be given as a shot into a muscle. The study will take place over several months, with participants receiving one or two doses of the vaccine, depending on their initial response. The goal is to understand how effective the vaccines are in preventing RSV infections in people who have had a stem cell transplant and to identify any patterns in the immune response that could predict how well someone might respond to the vaccine.

The research process

The trial runs in 6 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 randomly assigned to receive one of two vaccines: RSVPreF (Abrysvo) or RSVPreF3 OA (Arexvy). This assignment is random and ensures that each participant has an equal chance of receiving either vaccine.
Step 2
First vaccination
You will receive a single intramuscular injection of the assigned vaccine. This means the vaccine will be injected into a muscle, usually in the upper arm.
After the injection, you will be monitored for any immediate reactions and will be asked to return for a follow-up visit 28 days later.
Step 3
Follow-up visit
At the follow-up visit, 28 days after the first vaccination, a blood sample will be taken to measure your body's response to the vaccine. This is called seroconversion, which means checking if there is a significant increase in antibodies against the virus.
Based on the results, the study will determine if additional participants will receive the vaccine or if a second dose is needed.
Step 4
Second vaccination (if applicable)
If the study requires a second dose, you will receive another intramuscular injection of the vaccine 8 to 10 weeks after the first dose.
You will be monitored again for any immediate reactions and will be asked to return for another follow-up visit.
Step 5
Second follow-up visit
At this visit, another blood sample will be taken to assess your immune response to the second dose of the vaccine.
The study will use this information to evaluate the effectiveness of the vaccine and to understand how the immune system responds to it.
Step 6
Completion of participation
Once all required visits and tests are completed, your participation in the study will be concluded.
The information collected will contribute to understanding the vaccine's effectiveness and safety in individuals who have undergone allogeneic hematopoietic stem cell transplantation.

Who can join the trial?

3 criteria

Must have had a prior allo-HSCT (allogeneic hematopoietic stem cell transplantation) between 3 months to 5 years before the first vaccination. This means you received stem cells from a donor to help your body make new blood cells. If it has been more than 5 years, you can still participate if you are on medication for chronic GVHD (graft-versus-host disease), which is a condition where the donor cells attack your body.
Must be aged 18 years or older at the time of joining the study.
Must provide written informed consent, which means you agree to participate in the study after being fully informed about it.

Who cannot join the trial?

3 criteria

Patients who have had an allogeneic hematopoietic stem cell transplantation cannot participate. This is a type of stem cell transplant where the stem cells come from a donor.
Patients who are not within the specified age range for the study cannot participate. The study includes certain age groups, so if you are outside these groups, you may not be eligible.
Patients who are part of a vulnerable population are not eligible. This means people who might be at a higher risk of harm or exploitation.

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Centre hospitalier universitaire de Liege
Liege, Belgium

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Investigated drugs

RSVPreF (Abrysvo)
is a vaccine designed to protect against respiratory syncytial virus (RSV). In this clinical trial, the vaccine is being tested on patients who have received a stem cell transplant. The goal is to see if the vaccine can help their immune system produce more antibodies against RSV, which could help prevent infections. Participants will receive the vaccine through an injection, and researchers will measure how well their immune system responds by checking the levels of specific antibodies in their blood.
RSVPreF3 OA (Arexvy)
is another vaccine being tested in the same trial. Like RSVPreF (Abrysvo), it aims to protect against RSV by boosting the immune system's ability to fight the virus. This vaccine is also given as an injection, and the trial will assess how effectively it increases antibody levels in patients who have had a stem cell transplant. The study will compare the immune response of this vaccine to that of RSVPreF (Abrysvo) to determine which is more effective in preventing RSV infections.

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

What is already known about the treatment

Abrysvo
Abrysvo is administered as a single intramuscular injection and is currently being studied in a Phase II clinical trial for its effectiveness in patients who have undergone allogeneic hematopoietic stem cell transplantation. This vaccine is designed to protect against respiratory syncytial virus (RSV) by stimulating the immune system to produce antibodies that target the RSV F protein, a key component of the virus. Abrysvo is classified as a vaccine and is being evaluated for its ability to induce a strong immune response, known as seroconversion, in recipients.
Arexvy
Arexvy is given as a single intramuscular injection and is part of a Phase II clinical trial aimed at assessing its efficacy in individuals who have received allogeneic hematopoietic stem cell transplants. The vaccine works by prompting the immune system to generate antibodies against the RSV F protein, which is crucial for the virus's ability to infect cells. Arexvy is categorized as a vaccine and is being tested for its potential to trigger a significant immune response, or seroconversion, in those who receive it.

Investigated diseases

Allogeneic Hematopoietic Stem Cell Transplantation – This procedure involves transferring stem cells from a healthy donor to a recipient whose bone marrow or immune system is compromised. The process begins with conditioning therapy, which may include chemotherapy or radiation, to prepare the recipient's body. After the transplant, the new stem cells travel to the bone marrow, where they begin to produce new blood cells. The recipient's immune system gradually rebuilds, but there is a risk of graft-versus-host disease, where the donor cells attack the recipient's tissues. Over time, the recipient's body may accept the new cells, leading to improved blood cell production and immune function. The progression of recovery varies, with close monitoring required to manage complications and support the recipient's health.