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RecruitingPHASE2INTERVENTIONAL

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

This research study is for adults, aged 18 and older, who have received a lung or kidney transplant. It's designed to understand two main things about a special RSV (Respiratory Syncytial Virus) vaccine. Firstly, it wants to see how long the protection from the vaccine lasts in these individuals. Secondly, it will give another dose of the RSV vaccine to see how safe it is and how well it helps their immune system fight off the virus again. Participants will have already received one or two doses of this vaccine in a previous study. The study aims to gather important information to help protect transplant patients from serious RSV infections.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
GlaxoSmithKline
Enrolment target
184
Start
06 Aug 2025
Estimated completion
16 Jul 2027

What is this study about?

This study is looking into a vaccine designed to protect against Respiratory Syncytial Virus, often called RSV. RSV is a common virus that usually causes mild, cold-like symptoms, but it can be much more serious for certain groups of people, including those who have had organ transplants like a lung or kidney. Because transplant patients take medicines to stop their bodies from rejecting the new organ, their immune systems are weaker, making them more vulnerable to severe infections.

Specifically, this research is interested in adults aged 18 and over who have already had a lung or kidney transplant. These individuals would have taken part in an earlier study where they received either one or two doses of this special RSV vaccine. The current study wants to find out how long the protective effects of that vaccine last in their bodies. They will do this by checking their immune response over time.

Another important part of this study is to see what happens when these transplant patients receive a booster dose of the RSV vaccine. Researchers will check if this extra dose is safe for them and how well it helps to strengthen their immune system's ability to fight off RSV. By understanding these things, we can learn more about how best to protect vulnerable people, like transplant recipients, from the serious effects of RSV.

Key takeaways

  • Study for adults aged 18+ with lung or kidney transplants.
  • Investigates an RSV vaccine given in a past study.
  • Checks how long vaccine protection lasts.
  • Looks at safety and immune protection after a booster dose.
  • Aims to improve RSV protection for transplant patients.

Who may be eligible?

This study is looking for adults aged 18 or older who have had a lung or kidney transplant. You must have already taken part in a specific previous study (called RSV OA=ADJ-023) where you received one or two doses of the RSV vaccine being tested.

It's important that your transplant happened more than a year ago, and you must be taking regular medication to prevent your body from rejecting the new organ. For kidney transplant patients, your kidney function needs to be stable. For lung transplant patients, your lung function also needs to be stable. You should also be able to attend all study visits and follow the study instructions carefully.

If you are a woman, you can join if you are past menopause, have had certain operations (like removal of ovaries or womb), or if you are able to use effective birth control during and for a month after the study, and have a negative pregnancy test before starting.

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.

  1. Are you 18 years old or older?
  2. Have you had a lung or kidney transplant more than a year ago?
  3. Did you take part in the previous RSV OA=ADJ-023 vaccine study?
  4. Are you currently taking anti-rejection medicines for your transplant?
  5. Is your kidney or lung function stable?
  6. Are you able to attend all study visits and follow instructions?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive an additional dose of the RSV vaccine. You will need to attend appointments for blood tests, which allow the researchers to check your immune response and how long the vaccine's protection lasts. You will also be asked about any new health problems, to monitor how safe the vaccine is for you. Throughout the study, you may need to complete diary cards or use a phone for communication. The exact number of visits and the total length of your participation will be explained in detail by the study team, typically involving several follow-up visits over a period of time after vaccination.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as potentially boosting your protection against RSV, a virus that can be serious for transplant patients. However, there are also potential risks, like side effects from the vaccine, similar to any other vaccine (e.g., soreness at the injection site, fever, aches). The research team will carefully monitor you for any health changes. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (37)

  • GSK Investigational Site
    Verified postcode
    Lexington, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    St Louis, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    St Louis, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    Omaha, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    New York, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    Pittsburgh, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    Temple, United States· Recruiting
  • GSK Investigational Site
    Verified postcode
    Camperdown, Australia· Recruiting
  • GSK Investigational Site
    Verified postcode
    Birtinya, Australia· Recruiting
  • GSK Investigational Site
    Verified postcode
    Herston, Australia· Recruiting
  • GSK Investigational Site
    Verified postcode
    Edmonton, Canada· Recruiting
  • GSK Investigational Site
    Verified postcode
    Vancouver, Canada· Recruiting

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that can cause cold-like symptoms, but it can be very serious for babies, older adults, and people with weakened immune systems, like organ transplant patients.

What does 'immune response' mean?

An 'immune response' is how your body's defence system reacts to something like a vaccine or a virus. This study checks how well your body creates protection after getting the RSV vaccine, especially how long that protection lasts.

Why is this research important for transplant patients?

Transplant patients often have weaker immune systems due to their medications, making them more likely to get very sick from infections like RSV. This study helps us learn how to better protect them from this virus.

Will I get the RSV vaccine during this study?

Yes, if you qualify and choose to participate, you will receive an additional booster dose of the RSV vaccine that was given in the previous study.

Is this a new vaccine?

The vaccine being used in this study has been tested in a previous study. This current study is further looking into how long its protection lasts and how safe and effective a booster dose is for transplant patients.

How to find out more

US GSK Clinical Trials Call Center

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study Evaluating Persistence of the Immune Response of the…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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