NOPRODUCTHPB0003

• Research type

  Research Study

• Full title

  Profiling of serum HbsAg levels and Hepatitis B virus specific T-cells responses in Chronic Hepatitis B patients under antiviral treatment.

• IRAS ID

  187356

• Contact name

  P Kennedy

• Contact email

  p.kennedy@qmul.ac.uk

• Sponsor organisation

  Janssen R&D

• Duration of Study in the UK

  1 years, 9 months, days

• Research summary

  Chronic hepatitis B virus infection affects more than 240 million people worldwide and is a major risk in the development of liver diseases and cancer.
  Special proteins, called sAg, present on the surface of hepatitis B virus infected cells can be measured in the blood and tissues of affected individuals and used to determine the extent of their disease. Any decreases observed in these proteins may be a sign of a reduced risk of disease progression, or this may also mean that the immune system has started to regain some amount of control.
  Using treatments currently available for chronic hepatitis B, only a few individuals are able to stop taking their medication without risking further development of liver disease. Most will need to take these medicines indefinitely to retain some control over their disease.
  It is proposed that a way of providing more enduring disease control might be through the use of therapeutic vaccines. Therapeutic vaccines work by activating specific immune system cells which can help the body to clear virally infected cells..
  Measuring sAg and the number of immune system cells present in the blood is one way to monitor how successful such a vaccine might be. It is thought that any virally infected cells in the body would then be transported to the liver and destroyed.
  This study wants to carefully measure the levels of sAg and immune system cells in the blood and tissues of patients already taking conventional therapies, the aim is to assess their effect on the immune system, and determine how effective these treatments are.
  We plan to use these results in order to develop a profile of a group of patients who might be best suited to help in the evaluation of a first in human therapeutic vaccine

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  16/LO/0265

• Date of REC Opinion

  18 Apr 2016

• REC opinion

  Further Information Favourable Opinion