Zoster 039 (Herpes Zoster Vaccine in haematologic malignancies)

• Research type

  Research Study

• Full title

  A Phase III, randomised, observer-blind, placebo-controlled, multicentre study to assess the safety and immunogenicity of GSK Biologicals’ Herpes Zoster HZ/su candidate vaccine when administered intramuscularly on a two-dose schedule to adults aged 18 years and older with haematologic malignancies.

• IRAS ID

  117743

• Contact name

  Andy Peniket

• Sponsor organisation

  GlaxoSmithKline UK Ltd

• Eudract number

  2012-003438-18

• ISRCTN Number

  n/a

• Research summary

  Chicken pox is caused by the Varicella Zoster Virus. People who have had Chicken pox are at risk of getting shingles (caused by the same virus) when their body??s immune (protective) system is low. Patients who are having, or have just finished treatment for cancer (e.g. chemotherapy or immunotherapy) have a low immune system meaning they have a higher chance of getting shingles compared to people who have not had such treatment. Shingles can last a few months and be very painful. In some cases it can lead to severe and life threatening complications. Vaccines help the body??s immune system fight diseases. Currently, there is no available vaccine which can be given to people during or after certain cancer therapies to prevent shingles. The vaccine being investigated does not contain living virus (meaning patients cannot get the disease from it) but is made up of part of the virus that causes shingles. This study looks at the safety of this vaccine and how well it helps the immune system fight shingles in adults who are receiving, or have recently received cancer therapy. Worldwide, approximately 502 patients will be entered into this study, (including about 24 in the UK). Around half the patients will be given the study vaccine and half a dummy vaccine. Patients will not be told which vaccine they have been given. They will receive two injections of the same vaccine either before, during, or after their cancer therapy. Patients will be asked to record any side effects to the vaccine in a special diary. Patients will be in the study for 13-15 months. Any patients developing a shingles rash will be assessed to confirm diagnosis of shingles. The study is being funded by the pharmaceutical company developing the vaccine. It??s anticipated that approximately 7 UK hospitals will participate in the study.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  12/SC/0676

• Date of REC Opinion

  7 Jan 2013

• REC opinion

  Further Information Favourable Opinion