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RecruitingPHASE4INTERVENTIONAL

Clinical Trial Assessing the Immunogenicity of an Anti-pneumococcal Vaccination Strategy (PCV13+PPV23 Versus PREVENAR20) in Adult Patients Treated for a Lymphoma

This study is for adults being treated for lymphoma, a type of cancer. It compares two ways of protecting against serious pneumonia infections. One way involves getting two different pneumonia vaccines (Prevenar 13 and Pneumovax 23) a few months apart. The other way is to get a single shot of a newer vaccine called PREVENAR20. We want to see which vaccination method creates a stronger and longer-lasting immune response in people with lymphoma, who often have weakened immune systems due to their treatment. This will help doctors understand the best way to protect these patients from pneumonia.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Poitiers University Hospital
Enrolment target
160
Start
07 Sep 2021
Estimated completion
01 Jun 2029

What is this study about?

If you have lymphoma, your immune system can be weakened by treatments like chemotherapy. This means you might be more likely to get certain infections, including serious lung infections like pneumonia, compared to healthy people. Getting vaccinated against pneumonia is really important to help protect you.

For a while, the recommendation in France (and elsewhere) for people with weakened immune systems was to get two different pneumonia vaccines: first, Prevenar 13, and then, two months later, Pneumovax 23. This combination was thought to give good protection. However, there's a newer vaccine called PREVENAR20 that covers more types of pneumonia bacteria in a single shot, and health authorities are now looking into recommending it instead.

This study wants to find out which of these approaches – the two-vaccine course or the single PREVENAR20 vaccine – works better at boosting the immune system in adults with lymphoma. We'll be taking blood samples at different times after vaccination to measure how strongly your body's immune system has responded. The goal is to figure out the most effective way to help your body fight off pneumonia infections if you are living with lymphoma.

Key takeaways

  • Compares two different pneumonia vaccination plans for lymphoma patients.
  • Aims to find out which plan creates a stronger immune response.
  • Involves regular blood tests over about a year.
  • Helps improve future pneumonia protection for people with lymphoma.
  • Participation includes standard, approved pneumonia vaccines.

Who may be eligible?

To join this study, you need to be an adult (18 or older) who is currently being looked after by a blood cancer specialist (hematology unit). You should also have recently started or received your first course of chemotherapy for a specific type of lymphoma, either diffuse large B cell lymphoma or follicular lymphoma. You'd also need to be expected to live for at least six more months.

There are some reasons why you might not be able to join. For example, if you're taking certain medications that affect your immune system (other than standard lymphoma chemotherapy), or if you have an uncontrolled infection. You also can't have had a pneumonia vaccine recently, or have conditions like HIV, a very weak immune system, or severe kidney disease.

Safety is very important, so if you've ever had a severe allergic reaction to a vaccine or have serious blood clotting problems, you wouldn't be able to take part. Also, pregnant women or women who could become pregnant and are not using effective contraception cannot join the study.

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. Are you currently seeing a blood cancer specialist for treatment?
  3. Have you recently started chemotherapy for diffuse large B cell or follicular lymphoma?
  4. Have you avoided other pneumonia vaccines recently?
  5. Are you female and not pregnant or planning to become so without contraception?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of two groups: one group will receive two separate pneumonia vaccines (Prevenar 13, followed by Pneumovax 23 two months later), and the other group will receive one dose of the PREVENAR20 vaccine. You'll have several study visits over about a year or so, starting from when you get your first vaccine.

At these visits, blood samples will be taken to check your immune response to the vaccine. These checks will happen before vaccination, and at several points afterwards – for example, about a month after each vaccine dose, and then again at 3, 6, and 12 months later (the exact timings might vary slightly depending on which vaccine group you're in). Doctors will also watch carefully for any side effects from the vaccination.

Potential risks and benefits

The main benefit of taking part is that you will receive an approved pneumonia vaccination, which is important for your health if you have lymphoma. This study will help us understand the best way to protect people like you from serious infections, potentially improving future care. Risks are generally mild and similar to typical vaccinations, such as soreness or redness at the injection site. More serious reactions are very rare. You are free to withdraw from the study at any time without affecting your medical care.

Locations (7)

  • Chu Angers
    Verified postcode
    Angers, France· Recruiting
  • CHU Bordeaux
    Verified postcode
    Bordeaux, France· Terminated
  • CHU Limoges
    Verified postcode
    Limoges, France· Recruiting
  • Chu Nantes
    Verified postcode
    Nantes, France· Terminated
  • Ch Perigueux
    Verified postcode
    Périgueux, France· Recruiting
  • CHU Poitiers
    Verified postcode
    Poitiers, France· Recruiting
  • CHU Tours
    Verified postcode
    Tours, France· Recruiting

Common questions

What is pneumonia?

Pneumonia is a serious lung infection that can make it hard to breathe. It's especially risky for people with weakened immune systems.

What is lymphoma?

Lymphoma is a type of cancer that affects the immune system cells called lymphocytes.

Why do people with lymphoma need special vaccines?

Treatments for lymphoma can weaken your immune system, making you more vulnerable to infections like pneumonia, so good vaccination is key.

What does 'immunogenicity' mean?

Immunogenicity refers to how well a vaccine makes your immune system react and produce protective antibodies to fight off disease.

Will I know which vaccine I'm getting?

Yes, you will know which vaccine strategy you are receiving in this study.

How to find out more

Mathieu Puyade, MD, PhD

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 "Clinical Trial Assessing the Immunogenicity of an Anti-pneum…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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