"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 solid tumours having chemotherapy
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
Doctors often use chemotherapy to treat people with cancer. A side effect of chemotherapy is a drop in blood cells. The white blood cells are a part of the body’s immune system that fights infections. A drop in white blood cells can increase your risk of getting an infection.
Shingles is a virus that affects the nerves and can travel along the nerve to the skin, causing a painful rash. Because of their low levels of white blood cells, people having chemotherapy are at a greater risk of developing shingles. The HZ/su vaccine may help these people.
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
The aims of this trial are to find out
- How good the immune response to the HZ/su vaccine is for people with solid tumours having chemotherapy
- How safe the vaccine is for these people
Who can enter
You may be able to enter this trial if you
- Have any cancer apart from
leukaemia, lymphomaor myeloma
- Are to have a course of chemotherapy that causes a drop in blood cells
- 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
- Have 20 mg or more of daily steroid tablets within a month before having the vaccine
- Are having any anti cancer drugs, such as trastuzumab (Herceptin), that doesn’t cause a drop in white blood cells – if you are having it with chemotherapy you may be able to take part
- 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
- Finished a course of chemotherapy up to a month before having the HZ/su vaccine
- Have had chicken pox (varicella virus) 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 a phase 2/3 trial. It will recruit 210 people. 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.
The 4 groups in this trial are
- HZ/su vaccine before starting chemotherapy
- Dummy drug (placebo) before starting chemotherapy
- HZ/su vaccine during chemotherapy
- Dummy drug during chemotherapy
You have 2 injections of the vaccine or dummy drug. You have them as an injection into a muscle in your arm. The injections are about a month apart.
The researchers will take blood samples before each injection, a month after the 2nd injection, at the start of your last cycle of chemotherapy and then a year after the 2nd injection. This is to see how your immune system responds to the injections.
For some people having the vaccine or dummy drug before chemotherapy 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
- At the start of your last cycle of chemotherapy
- A year after your 2nd injection
About 4 months after your 2nd injection a member of the study team will call you to see how you are. They will call you again 4 months later.
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 Hartmut Kristeleit
National Institute for Health Research Cancer Research Network (NCRN)