Varicella Zoster vaccine in autologous stem cell transplant subjects

• Research type

  Research Study

• Full title

  A phase III, randomised, observer-blind, placebo-controlled, multicentre, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of GSK Biologicals' herpes zoster gE/AS01b candidate vaccine when administered intramuscularly on a two-dose schedule to adult autologous haematopoietic stem cell transplant (HCT) recipients

• IRAS ID

  101757

• Contact name

  Adrian Bloor

• Sponsor organisation

  GlaxoSmithKline UK Pharma Ltd

• Eudract number

  2012-000138-20

• 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 (which is caused by the same virus) when their body's immune system is low. Patients who have had a stem cell bone marrow transplant to treat cancer of the blood have a low immune system so have a higher chance of developing shingles compared with the general population. Shingles can last a number of months, be very painful and lead to severe and life threatening complications. At the moment, there is no vaccine available that can be given to people after stem cell transplants to prevent shingles. Vaccines help the body??s immune system to fight diseases. The vaccine being investigated is not a live vaccine but is made up of a part of the shingles causing virus. The study will investigate whether the vaccine will stop patients aged 18 and over who have just received a stem cell transplant from getting shingles, prevent or reduce shingles pain (both short and long term pain), prevent shingles complications and assess the vaccine's safety. Worldwide, approximately 1474 patients will be recruited (including 60 in the UK). Patients will be given either the VZV or a dummy vaccine, with approximately half the patients in each group. Patients will not be told which vaccine they have been given. They will receive two doses of the same vaccine after their stem cell transplant. Patients will then be followed for up to 4 years. Any patients developing shingles will be asked to complete questionnaires to assess the severity of their pain and the impact of this on their day to day life. The study is being funded by the pharmaceutical company who is developing the vaccine. It is anticipated that 8 UK hospitals will participate.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  12/NW/0311

• Date of REC Opinion

  15 May 2012

• REC opinion

  Favourable Opinion