Research Trial Assessing the Immunogenicity and Safety of Three Meningococcal B Vaccine Strategies Among Patients With Asplenia.
This research is investigating the best way to protect people who have had their spleen removed (asplenia) from a serious illness called Meningitis B. Individuals without a spleen are more susceptible to infections like Meningitis B. The study will test two existing Meningitis B vaccines, Trumenba® and Bexsero®, using three doses over several months. Researchers want to understand if these boosted vaccination plans create a strong enough immune response in these high-risk patients and how long that protection lasts. This is important because there isn't much information currently available about how well these vaccines work in people without a spleen.
At a glance
What is this study about?
If you've had your spleen removed, you might be more vulnerable to certain infections, including a serious type of meningitis called Meningitis B. While there are vaccines available for Meningitis B, we don't have much information about how well they work specifically in people who no longer have a spleen, especially in France where this study is based. It's thought that without a spleen, your body might not respond as strongly to vaccines as someone with a healthy spleen.
This study aims to find out the best way to vaccinate people without a spleen against Meningitis B. We'll be looking at two vaccines, Trumenba® and Bexsero®, which are already approved and used. Instead of the usual two doses, this study will give three doses over several months. By doing this, we hope to 'boost' the immune system's response to create stronger and longer-lasting protection.
Understanding how these vaccines work in patients without a spleen is really important. The results could help doctors decide the best vaccination plan to keep these vulnerable patients safe from a potentially life-threatening infection. The study will also track how long the protection from the vaccines lasts.
Key takeaways
- This study evaluates Meningitis B vaccines specifically for people without a spleen.
- It tests three doses of either Trumenba® or Bexsero® over six months.
- The goal is to see if a stronger immune response is created and how long it lasts.
- It aims to improve protection for high-risk patients.
- Participation involves multiple visits and blood tests over four years.
Who may be eligible?
To be part of this study, you need to be an adult between 18 and 75 years old and have had your spleen removed at least two weeks before joining. Your doctor must be able to confirm that your spleen was removed, for example, from hospital records or ultrasound scans, and a blood test must show specific cells called Howell Jolly bodies, which indicate your spleen is not working.
There are also some important reasons why you might not be able to join. For example, if you've already had a Meningitis B vaccine, or if you've had a severe allergic reaction to any vaccine in the past. We also can't include you if you're allergic to any ingredients in the study vaccines. If you're on certain medications that affect your immune system, like high-dose steroids or chemotherapy, or have certain health conditions like HIV or advanced cancer, you might not be suitable.
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 between 18 and 75 years old?
- Has your spleen been completely removed at least two weeks ago?
- Can your doctor confirm your spleen removal from medical records?
- Have you NOT had a Meningitis B vaccine before?
- Are you NOT taking certain medications that suppress your immune system?
What does participation involve?
If you join the study, you'll receive three doses of either the Trumenba® or Bexsero® vaccine over approximately six months (at the start, one month later, and six months later). You'll have several study visits and blood tests over four years to check your immune response and overall health. Some visits might involve checking your medical history and doing a physical exam. It's important that you don't receive certain other vaccines during parts of the study, and you can't be taking certain medications that affect your immune system. If you are a woman who could become pregnant, you'll need to use effective contraception for the first nine months of the study.
Potential risks and benefits
Locations (1)
- I-REIVAC/CIC1417 Cochin Hospital, AP-HPVerified postcodeParis, France· Recruiting
Common questions
What is Meningitis B?
Meningitis B is a serious infection that can cause inflammation of the lining around the brain and spinal cord, or a blood infection. It can be life-threatening.
Why are people without a spleen more at risk?
The spleen plays a vital role in fighting off certain types of infections, including Meningitis B. Without a spleen, your body may not be as good at clearing these infections.
What are the vaccines Trumenba® and Bexsero®?
These are both approved vaccines that help protect against Meningitis B. They work by teaching your immune system to recognise and fight off the bacteria if you encounter it.
Will I have to pay to be in the study?
No, all study-related treatments, medical exams, and laboratory tests will be provided at no cost to you. You must be covered by social security or equivalent healthcare.
How long will I be involved in the study?
You'll receive vaccine doses over about six months, and then you'll be followed up for a total of four years to check how your immune response lasts.
How to find out more
Odile LAUNAY, MD,PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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