Zoster-056 (Cross vaccination study)
Research type
Research Study
Full title
A Phase IIIB, non-randomized, open-label, multi-country, multi-centric cross-vaccination study to evaluate the safety of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine when administered intramuscularly on a two-dose schedule to subjects who previously received placebo in ZOSTER-006 and ZOSTER-022 studies.
IRAS ID
200206
Contact name
Janice Patrick
Contact email
Eudract number
2015-000965-30
Duration of Study in the UK
1 years, 7 months, 0 days
Research summary
Varicella-Zoster Virus (VZV) causes two distinct diseases, Varicella (chickenpox) and Herpes zoster (shingles). Shingles occurs when VZV reactivates in the body and causes a Herpes Zoster (HZ) rash which usually lasts 2 to 4 weeks and is often accompanied by severe pain. Age is the most common risk factor for developing HZ. The incidence of HZ is relatively constant at 2-3 cases per 1000 persons per year until age 40, and then increases progressively with age to 10 cases per 1000 persons per year in people ≥ 60 years of age (YOA).\n\nTwo large pivotal Phase III trials (ZOSTER-006 enrolling subjects ≥ 50 YOA, and ZOSTER-022 enrolling subjects ≥ 70 YOA,) have been conducted to evaluate the GSK’s HZ/su vaccine for the prevention of HZ. The results from both studies are now known and they showed that the HZ/su vaccine greatly lowers the chance to get shingles, and that it did not seem to raise safety concerns.\n\nSince the HZ/su vaccine has not yet been licensed and marketed, the Zoster 056 study is being conducted to enable potentially eligible subjects who previously received placebo in ZOSTER-006 or ZOSTER-022 to receive the HZ/su vaccine.\n\nThere are approximately 14,550 potential subjects globally with 650 of those subjects coming from nine sites in the UK. All potential subjects must satisfy the protocol inclusion and exclusion criteria in order to be eligible for enrolment into the study.\n\nThe study will last for about 14 months. Each subject will be vaccinated at visit 1 and visit 2 (60 days later) and will be followed for safety approximately 12 months after the second vaccine dose. There are five study visits for each subject Visit 1 and 2 will require the subject to come to study site for vaccine administration. Visit 3, 4 and 5 will be follow-up visits and will be phone contacts. \n
REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0134
Date of REC Opinion
22 Mar 2016
REC opinion
Favourable Opinion