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22 June 2018

CONSTANT study

University Hospitals Bristol NHS Foundation Trust is recruiting healthy adults aged 18-45 years to a research study of a new investigational Hepatitis B vaccine.

Hepatitis B is a viral infection that can be transmitted between people by close contact, between pregnant mothers and their infants around the time of delivery and in the healthcare setting by contaminated needles or body fluids. It can cause a serious acute illness affecting the liver and causing jaundice. In some people the infection becomes chronic and can lead to liver failure or liver cancer. At present there is no curative treatment for hepatitis B.

Highly effective vaccines that protect against acquiring the infection have been available since the 1980s. Until recently, in the UK, vaccination was provided to people at increased risk of hepatitis B including healthcare workers, infants of mothers with hepatitis B and people who share needles. Since 2016 all infants are offered to protection against hepatitis B along with several other infections as part of the universal primary immunisation programme for all children.

However, most of the adult population in the UK have never received a vaccination against hepatitis B.

In this study, people taking part are all given hepatitis B vaccine. Either they receive doses of a new investigational vaccine which has been in use for some time in other countries but is not yet approved in Europe or doses of a vaccine that has been licensed and in use in Europe for many years. The new investigational vaccine contains 3 slightly different versions of the hepatitis B protein that induces protective immune responses and may produce high levels of seroprotection against Hepatitis B. The study aims to show that different lots of the investigational vaccine produce the same immune response and to test whether this response is at least as good as the licensed vaccine. Neither vaccine contains any live viruses and so neither can cause any infection.

In the study, blood samples are taken to check the level of the immune response. Participants are compensated for travel costs and time and trouble.

T. Segun, a patient from St. George's, London said: "I went through hell when I had hepatitis B virus. Had I known I would have been vaccinated against this virus before I got it. I really recommend people get vaccinated against hepatitis B virus, as no one knows when and how one may get infected through blood or bodily fluids."

People interested in knowing more about the study should contact:

Tel: 0117 342 9212

Email: hepatology.research@uhbristol.nhs.uk


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