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.

Cancer type:

All cancer types

Status:

Closed

Phase:

Phase 2/3

This trial is looking at a new vaccine called HZ/su to prevent shingles Open a glossary item in people having chemotherapy to treat any cancer apart from a blood cancer (a solid tumour ).

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 immune response Open a glossary item .

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 , lymphoma or 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 vaccine up 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

Trial design

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

Vaccine to prevent shingles in people with solid tumours having chemotherapy trial diagram

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.