"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 shingles in people with blood cancers
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is looking at a new vaccine called HZ/su to prevent shingles in people who are having, or have had treatment for blood cancers, such as leukaemia, lymphoma and myeloma.
Doctors can use chemotherapy or
The vaccine consists of an inactive part of the virus that causes shingles with a substance that helps the body strengthen its defence against shingles. We know from research that the vaccine can help the body’s immune system make antibodies against shingles. This is called an
In this trial the researchers will compare people who have the HZ/su vaccine with people who have a dummy drug (
- Whether the vaccine produces expected side effects
- How safe the vaccine is
They will also look at how good the immune response to the vaccine is for people with certain types of blood cancer.
Who can enter
You may be able to enter this trial if you
- Have a blood cancer, such as leukaemia, lymphoma or myeloma
- Are having or have had chemotherapy or immunotherapy
- Are willing to use reliable contraception for a month before having the vaccine, while having the vaccine and for 2 months afterwards if there is any chance you could become pregnant
- Are at least 18 years old
You cannot enter this trial if you
- Are taking only tablets to treat chronic lymphocytic leukaemia – if you are having treatment through a drip (
intravenous infusion) as well as tablets you may be able to take part
- Are having radiotherapy only
- Are to have a stem cell transplant
- Have had a stem cell transplant in the 7 weeks before starting treatment in this trial
- Have had a vaccination against herpes zoster virus or chicken pox (varicella virus) in the past year
- Plan to have a vaccination against herpes zoster or chicken pox in the near future
- Have had an experimental drug as part of a clinical trial in the past month
- Have had chicken pox or herpes zoster virus infection in the past year
- Are allergic to the HZ/su vaccine or any of its ingredients
- Have a
live vaccineup to a month before starting the HZ/su vaccine
- Have a non live vaccine 8 days before starting the HZ/su vaccine and 2 weeks after having the HZ/su vaccine
- Are HIV positive
- Have a fever or any other medical condition that could affect you taking part in this trial
- Are pregnant or breastfeeding
This is an international phase 3 trial. It will recruit 552 people from different countries around the world. It is a randomised trial. The people taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in.
Half the people recruited will have the HZ/su vaccine and the other half will have a dummy drug (placebo).
You have 2 injections of the vaccine or dummy drug. You have them as an injection into the muscle of your arm. Each injection is about a month apart.
The researchers will take blood samples before each injection, a month after the 2nd injection then a year after your 2nd injection. This is to see how your immune system responds to the injections.
For some people the researchers will take some extra blood samples. This is for a different type of test to see how your immune system responds. Your doctor will tell you if you are one of these people.
Each time you have an injection the researchers will give you a diary card to fill in. This is to record any side effects you may have from the injection. The team will tell you how and when to fill it in.
You see the doctor for a physical examination before taking part in this trial.
You then see the doctor
- About 1 month after each injection
- A year after your 2nd injection
About 6 months after your 2nd injection a member of the study team will call you to see how you are.
The most common side effects of the HZ/su vaccine are
- Pain, redness and swelling at the injection site
- Tiredness (fatigue)
- Muscle pain
- Feeling or being sick (nausea)
- Tummy (abdominal) pain
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr Andy Peniket
NIHR Clinical Research Network: Cancer