Immunogenicity after a prime dose and revaccination with adjuvanted RSVPreF3 vaccine in the most elderly and frail population – an open-labeled phase IIIb-trial RSV Immunogenicity Study in the Elderly (RISE)
The RISE study is a clinical trial focused on understanding the Arexvy vaccine for Respiratory Syncytial Virus (RSV) in older adults. RSV can cause serious chest infections, especially in the elderly. This study aims to see how strongly the immune system responds to the vaccine in people aged 60 to 65, and also in those who are 80 years old or older. Researchers will measure specific protective substances (antibodies) in the blood one month after people receive their first dose of the vaccine. They are also carefully monitoring for any side effects, both mild and more serious, to ensure the vaccine is safe for this age group. This information helps us understand how well the vaccine might protect vulnerable older people.
At a glance
What is this study about?
This study, known as RISE, is looking into a vaccine called Arexvy, which helps protect against a common chest infection called Respiratory Syncytial Virus, or RSV. RSV can be particularly serious for older people and those with other health conditions, sometimes leading to hospital stays. The main goal of this study is to understand how effectively the vaccine helps the body build protection against RSV.
Specifically, researchers want to see how the immune system responds one month after people receive their first vaccination. They will be measuring something called 'neutralising antibodies' in the blood. These antibodies are like little soldiers that help fight off viruses. The study is particularly interested in two age groups: people aged 60 to 65, and those aged 80 and over, to see how different age groups react to the vaccine.
Beyond just checking the protective response, a very important part of this study is to carefully monitor for any side effects. Researchers will track any reactions at the injection site, like soreness, and any general body reactions, like fever. They will also look for any unexpected or serious health problems that might occur during the study period. This detailed monitoring helps ensure the vaccine is as safe as possible for older individuals.
Key takeaways
- The study investigates the Arexvy vaccine's effectiveness against RSV in older adults.
- It focuses on specific age groups: 60-65 and 80+ years old.
- Researchers will check your immune response by measuring protective antibodies.
- The study also carefully monitors for any side effects to ensure safety.
- Participation helps improve protection against RSV for vulnerable older people.
Who may be eligible?
To join this study, you need to be an adult, either aged between 60 and 65, or aged 80 or above. Both men and women can take part. The researchers are specifically looking at how the vaccine works in these particular age groups.
As this study focuses on specific age groups, there will likely be other health requirements that decide if you can join. These will ensure that the study is safe for you and that the results are clear. Your doctor will be able to discuss these with you based on your personal health.
It's important to remember that not everyone who meets the basic age and sex criteria will be able to join. There will be detailed medical checks to make sure the study is right for you and that you meet all the necessary health conditions.
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 aged between 60 and 65, or 80 years old or above?
- Are you able to attend clinic visits as required?
- Are you willing to have blood tests?
- Are you able to report any new symptoms or health changes?
- Are you comfortable with receiving an investigational vaccine?
What does participation involve?
If you decide to join the RISE study, you would receive the Arexvy vaccine. After your vaccination, the research team would closely monitor your health. You would have a blood test about one month after getting the vaccine to measure your body's immune response. For about four days after each vaccination, you would be asked to keep track of any common side effects, like soreness where you had the jab, or feeling a bit under the weather. For a longer period of 30 days after each vaccination, you'd also report any other health problems you experience. The study will also track any serious health issues for up to six months, and any fatal events until the study ends. You would have scheduled visits to the clinic for these assessments and to discuss any side effects.
Potential risks and benefits
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Common questions
What is RSV?
RSV stands for Respiratory Syncytial Virus. It's a common virus that can cause cold-like symptoms but can lead to more serious breathing problems, especially in babies, older adults, and people with weakened immune systems.
What is the Arexvy vaccine?
Arexvy is a vaccine designed to help protect against serious illness caused by the RSV virus. It helps your body's immune system learn to fight off the virus if you encounter it.
Why are older people being studied?
Older adults, particularly those aged 60 and over, are at higher risk of developing severe RSV infection. This study helps us understand how well the vaccine works and is tolerated in these specific age groups.
What are 'neutralising antibodies'?
Neutralising antibodies are special proteins made by your immune system. They can recognise and 'neutralise' viruses, like RSV, stopping them from infecting your cells and causing illness.
Do I have to pay to be part of the study?
No, you don't have to pay to participate in a clinical trial. Any study-related vaccines, tests, or visits will be covered by the study organisers.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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