"I was delighted to take part in a clinical trial as it has the potential to really help others in the future.”
A trial looking at a vaccine to prevent infections in children with acute lymphoblastic leukaemia
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a
The trial is for children and young people up to and including the age of 18. We use the term ‘you’ in this summary, but if you are a parent, we are referring to your child.
Chemotherapy can affect your
The aim of this study is to find out if a new vaccine can help prevent pneumococcal infection in children who are having or have just finished treatment for ALL.
Who can enter
You may be able to enter this trial if you
- Have acute lymphoblastic leukaemia (ALL)
- Are having treatment for ALL, or have finished treatment in the last 6 months
- Are between 2 and 18 years old
You cannot enter this trial if you
- Have problems with your
immune systemthat are not caused by chemotherapy
- Have taken medicine in the last 6 months to damp down your immune system – your doctor will discuss this with you
- Are known to be allergic to the vaccination
- Are known to be allergic to diphtheria vaccination
- Are pregnant or breastfeeding
This trial will recruit 120 people from the UK. There are 3 treatment groups. Each group has the same vaccine. The vaccine is an injection into your thigh or arm muscle. You have 1 vaccination and are on the trial for a year.
- Group 1 have the vaccine while they are having treatment to keep the ALL away (maintenance treatment)
- Group 2 have the vaccine at the end of treatment
- Group 3 have the vaccine within 6 months of finishing treatment
This study does not affect your cancer treatment and you see your cancer doctors while you are on the study.
You will see the doctors and have some tests before you have the vaccine. The tests include
- Physical examination
- Blood tests
- Swabs of your nose and throat
The study nurse will see you 1 month after your vaccination for blood tests and to see how you are. You see the study nurse again a year after the vaccination for blood tests and swabs of your nose and throat. This is the end of the trial.
The most common side effects of the vaccination are pain, swelling, tenderness and redness where you had the injection. This will go after 1 or 2 days.
How to join a clinical trial
Dr Juliet Gray
NIHR Clinical Research Network: Cancer
NIHR Research for Patient Benefit (RfPB) Programme
University Hospital Southampton NHS Foundation Trust