Zoster 022 (113077) Herpes Zoster Vaccine Study in adults 70 yrs+

• Research type

  Research Study

• Full title

  A phase III, randomised, observer blind, placebo-controlled, multicentre, clinical vaccination trial to assess the prophylactic efficacy, safety and immunogenicity of GSK Biologicals' gE/AS01B vaccine when administered intramuscularly on a 0,2-month schedule in adults aged 70 years and older.

• IRAS ID

  60181

• Contact name

  Alex Thompson

• Sponsor organisation

  GlaxoSmithKline Biologicals

• Eudract number

  2009-015791-94

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  The main purpose of this study is to assess whether the Herpes Zoster vaccine's effective in preventing Herpes Zoster, commonly known as Shingles, compared to placebo in adults aged 70 years and over. Herpes Zoster (HZ), or shingles, occurs when the Varicella Zoster Virus (which causes chickenpox) is reactivated and it usually appears as a localised skin rash. The rash normally lasts 2 to 4 weeks usually with a pain that's often described as burning, shooting, or stabbing and some patients experience increased sensitivity to pain in the affected area. The most common complication of shingles (HZ) is postherpetic neuralgia (PHN). This is a pain that continues after the rash has cleared. Affected patients typically report constant burning, throbbing, intermittent sharp or electric shock-like pain. Older people are more likely to develop PHN. If PHN develops it tends to improve over a period of months and about 70-80% of cases resolve within a year, however in some people it can persist for many years. Age is also the most common risk factor for developing shingles: at 50-59 yrs. the incidence is about 5 cases in 1000 persons per year, & in those 60 yrs. and over this increases to 10 cases in 1000 persons per year. Half of all cases of shingles occur in people 60 yrs. & over. In the study eligible subjects will either receive 2 doses of the study vaccine or a placebo. One dose will be given at the first visit and the second dose at the 2nd visit. These doses will be given 2 months apart. All subjects will be followed up for at least 30 months with annual visits and monthly contacts (phone and/or email) after visit 3. The exact length of the study for individual subjects will vary, the maximum being 4-5 years.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/47

• Date of REC Opinion

  9 Sep 2010

• REC opinion

  Further Information Favourable Opinion