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.

Cancer type:

Acute leukaemia

Acute lymphoblastic leukaemia (ALL)

Blood cancers

Children's cancers

Leukaemia

Status:

Closed

Phase:

Other

This trial is looking at a vaccine Open a glossary item to help prevent infections in children who are having or have recently finished treatment for acute lymphoblastic leukaemia (ALL).

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 immune system Open a glossary item , which helps to fight infection. Doctors know that children having chemotherapy for ALL are at increased risk of an infection called pneumococcus. In this trial doctors want to use a new vaccine to help protect against pneumococcal infection.

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 system that 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

Trial design

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.

Hospital visits

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.

Side effects

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.