Zoster 062 (204939)
Research type
Research Study
Full title
A phase III, randomized, observer-blind, placebo controlled, multicenter clinical trial to assess Herpes Zoster recurrence and the reactogenicity, safety and immunogenicity of GSK Biologicals’ Herpes Zoster vaccine (HZ/su) when administered intramuscularly on a 0 and 2 month schedule to adults ≥ 50 years of age with a prior episode of Herpes Zoster.
IRAS ID
252921
Contact name
Nell Wyatt
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals
Eudract number
2016-000744-34
Clinicaltrials.gov Identifier
BB-IND-13857, Investigational New Drug (IND) Number
Duration of Study in the UK
3 years, 9 months, 3 days
Research summary
Shingles is an infection caused by the same virus that causes chickenpox. After getting chickenpox during childhood, the virus remains dormant in the body. Shingles occurs when the virus becomes active again after many years, mostly when people are older than 50 years. The chance of getting shingles is higher as people get older.
GlaxoSmithKline is funding this study to learn more about how the vaccine changes the chance of having another shingles attack, how people react to the vaccine injection, how the vaccine works on the immune system and how safe it is.
In total about 1426 participants over 50 years old who have previously had shingles (approximately 280 recruited from GP sites in the UK) will take part in this study.
Participants will come to the clinic at least 3 times and will have monthly follow-up contact for 2 to 4 years, depending on the point in the study at which they are enrolled.
Participants entering the study will get 2 doses of either the vaccine or placebo (dummy vaccine) given into the arm muscle. The first dose is given on the first visit and the second dose is given 2 months after the first. The study is blinded so participants don’t know which injection is placebo. Blood samples will be taken from participants during the first three visits for measuring the immune response.
The study assessments will include: demographic data, medical history, physical examination, pregnancy test (if applicable), pre-vaccination body temperature, completion of diary card, and safety monitoring.
Participants will be observed for at least 30 minutes after each vaccination.
If participants develop shingles while on study, they will have to make extra trips to the clinic for additional assessments, which include: clinical examination, completion of diary card and shingles questionnaire, taking photographs of the shingles rash and collecting samples from the shingles rash.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
19/EM/0223
Date of REC Opinion
21 Aug 2019
REC opinion
Further Information Favourable Opinion