Zoster vaccine in patients recieving chemotherapy for solid tumours

• Research type

  Research Study

• Full title

  A phase II/III, randomised, observer-blind, placebo-controlled, multicentre, clinical trial to assess the immunogenicity and safety of GSK Biologicals’ herpes zoster HZ/su candidate vaccine when administered intramuscularly on a 0 and 1 to 2 months schedule to adults =18 years of age with solid tumours receiving chemotherapy.

• IRAS ID

  118437

• Contact name

  Hartmut Kristeleit

• Sponsor organisation

  GSK

• Eudract number

  2012-002966-11

• ISRCTN Number

  N/A

• Research summary

  Chicken pox is caused by a virus called Varicella Zoster Virus (VZV). People who have had Chicken pox are at risk of developing shingles (caused by the same virus) when their body??s immune (protective) system is low. Patients who are having treatment for cancer (chemotherapy) have a lowered immune system meaning they have a higher chance of getting shingles compared to people who are not having chemotherapy. Shingles can last a few months and be very painful. In some cases it can lead to severe and life threatening complications. Currently, there is no available treatment which can be given to people during chemotherapy to prevent shingles. Vaccines help the body??s immune system to fight diseases. The vaccine being investigated is not a live vaccine (meaning patients cannot get the disease from it) but is made up of a part of the virus that causes shingles. This study looks at the safety of the vaccine and how well it helps the immune system fight shingles in adults who are receiving chemotherapy.Worldwide, approximately 200 patients will be entered into this study (including 20 to 30 in the UK). Approximately 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 and will receive the first dose either before or at the start of their first or second chemotherapy treatment. Patients will be asked to record any side effects to the vaccine in a special diary. Patients will be in the study for approximately 14 months. The study is being funded by the pharmaceutical company who is developing the vaccine.It is anticipated that 6-7 UK hospitals will participate in the study.

• REC name

  London - South East Research Ethics Committee

• REC reference

  12/LO/1909

• Date of REC Opinion

  13 Feb 2013

• REC opinion

  Further Information Favourable Opinion