Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2b, randomized, controlled, open-label study to evaluate the immune response and safety of the RSVPreF3 OA investigational vaccine in adults (≥18 years of age) when administered to lung and renal transplant recipients comparing 1 versus 2 doses and compared to healthy controls (≥50 years of age) receiving 1 dose

This research is investigating a new vaccine (called Arexvy) designed to protect against Respiratory Syncytial Virus (RSV) infections. RSV can be serious, especially for people with weakened immune systems. The study focuses on adults aged 18 and over who have received a lung or kidney transplant. We want to understand how their bodies react to the vaccine and how safe it is. Some transplant patients will receive one dose of the vaccine, while others will receive two. We'll compare their responses to healthy adults aged 50 and over who receive one dose. This will help us learn the best way to protect vulnerable people from RSV.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

GlaxoSmithKline Biologicals

Enrolment target

130

Start

02 Oct 2023

Respiratory Syncytial Virus Infections

What is this study about?

This study is about a new vaccine that aims to protect people from a common virus called RSV (Respiratory Syncytial Virus). RSV can cause cold-like symptoms, but it can be much more severe for some, especially those with weaker immune systems. This includes people who have had organ transplants, like a new lung or kidney. For them, catching RSV can lead to serious health problems.

The main goal of this research is to see if this new vaccine, called Arexvy, helps their body build up protection against RSV. We also want to make sure it's safe for them to use. To do this, some transplant patients will get one dose of the vaccine, and others will get two. We'll then compare how well their bodies respond to the vaccine. We're also comparing them to healthy people over 50 who get one dose of the vaccine to see the differences in how their immune systems react.

By carefully studying how the vaccine works and if it causes any side effects, we hope to find the best way to protect people who have had organ transplants from getting seriously ill with RSV. This is important because preventing RSV could significantly improve their health and quality of life.

Key takeaways

This study is testing a new vaccine for RSV in adults who have had lung or kidney transplants.
It aims to see if the vaccine helps their bodies fight off RSV and if it's safe.
Some transplant patients will get one dose, others two, and they'll be compared to healthy participants.
You'll have clinic visits for blood tests and health checks.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older. A key part of this research is that you must have received either a lung or kidney transplant. This allows us to specifically study how the vaccine works for people with weakened immune systems due to their transplant.

Healthy adults aged 50 or over are also invited to take part. They will help us compare the vaccine's effects in transplant patients with those in a healthy older population. This helps us understand the vaccine's performance across different groups.

The research team will carry out several checks to make sure the study is right for you and that you meet all the specific health criteria. They will discuss all the details with you carefully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had a lung or kidney transplant?
Alternatively, are you a healthy adult aged 50 or over?
Are you able to attend several clinic appointments for blood tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the study vaccine as an injection. Depending on which group you are in, you might receive one or two doses. The vaccine is given as a powder mixed with liquid, just like many other common vaccines.

Throughout the study, you will have several visits to the clinic. At these visits, the research team will take blood samples to see how your immune system is reacting to the vaccine. They will also ask you how you are feeling and if you have experienced any side effects. This helps them monitor your safety.

You will be monitored for a period after receiving the vaccine to track any potential side effects. The total duration of your involvement in the study will be explained in full detail by the study team, including any follow-up appointments.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of protection against RSV infection, particularly if you are in a vulnerable group like transplant recipients. However, there's no guarantee the vaccine will protect you. Like all medicines, the study vaccine may have side effects, which could include soreness, redness, or swelling where the injection was given, or more general side effects like feeling tired or having a headache. The study team will closely monitor you for any side effects. Remember, joining a clinical trial is always voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain
—
Unverified
Italy
—
Unverified
Germany

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that usually causes mild, cold-like symptoms, but it can be more serious for babies, older adults, and people with weakened immune systems, like those who have had organ transplants.

What is a 'Phase 2b' study?

A Phase 2b study means the vaccine has already been tested in a smaller group of people. In this phase, researchers are looking at how well the vaccine works (its 'immune response') and continuing to check its safety in a larger group of people with specific health conditions.

What does 'investigational vaccine' mean?

It means the vaccine is still being studied and is not yet approved for general use. Researchers are trying to learn more about how it works and if it's safe and effective before it can be made widely available.

Will I know if I'm getting one or two doses if I'm a transplant patient?

Yes, this is an 'open-label' study, which means both you and the study team will know whether you are receiving one or two doses of the vaccine. This is different from 'blinded' studies where no one knows.

Will I have to pay to join the study?

No, you will not have to pay to participate in the study. All study-related treatments and tests will be provided at no cost to you.