Zoster 015 - Herpes zoster vaccine in adult HIV-infected subjects.

• Research type

  Research Study

• Full title

  A phase I/IIa randomized, observer-blind, placebo-controlled, multicenter study to evaluate the safety and immunogenicity of the GSK Biologicals’ herpes zoster vaccine, gE/AS01B in comparison to placebo when administered as 3 doses to adult HIV-infected subjects.

• IRAS ID

  57710

• Contact name

  Graeme Moyle

• Eudract number

  2009-017809-11

• ISRCTN Number

  Eudract

• Research summary

  The purpose of this study is to assess the safety and to measure the bodies' immune response following administration of the Herpes Zoster (HZ) vaccine compared to placebo in HIV-infected adults. HZ, commonly known as shingles, occurs when the Varicella-zoster virus (VZV) (which causes chickenpox) becomes active (reactivation). HZ presents as a painful localised skin rash. While it is not known what triggers VZV reactivation, the elderly, patients with a deficient immune system (immunnocompromised) or persons receiving certain medcines are at increased risk of developing HZ. The most common complication of HZ is postherpetic neuralgia (PHN). This is a pain that continues after the rash has cleared and is reported as constant burning, throbbing, intermittent sharp or electric shock-like pain which can continue for months. In immunocompromised persons (ie, HIV patients), there is an increased risk for developing HZ and having recurrent HZ. The rash tends to be more severe and last longer, there is a higher risk of HZ associated neurological complications and patients are more likely to develop HZ which involves various organs or skin areas which can be fatal. The HZ vaccine does not contain live virus, therefore it is expected that the vaccine will be safe in immunocompromised persons. This study will be conducted in a step-wise approach. Firstly, the vaccine will be given to subjects who are receiving Antiretroviral Therapy (ART) with a high CD4 count. If there are no safety concerns with the initial 25 patients recruited, enrolment into the ART low CD4 cohort and the ART naive cohort will commence. Subjects will receive 3 vaccines at Months 0, 2 and 6 and will be followed up until Month 18. Another safety review will be conducted to assess whether the more immunocompromised cohorts can receive the 3rd vaccination. This study will be conducted in the UK, USA and Germany.

• REC name

  London - Central Research Ethics Committee

• REC reference

  10/H0718/49

• Date of REC Opinion

  7 Sep 2010

• REC opinion

  Further Information Favourable Opinion