GSK's paediatric HZ vaccine in paediatric renal transplant patients
Research type
Research Study
Full title
A Phase II, randomised, open-label, multicentre study to assess the reactogenicity, safety and immunogenicity of GSK's paediatric Herpes Zoster subunit candidate vaccine (PED-HZ/su) when administered intramuscularly on a two-dose schedule to immunocompromised paediatric renal transplant recipients from 1 to 17 years of age.
IRAS ID
263468
Contact name
Stephen Marks
Contact email
Sponsor organisation
GSK
Eudract number
2019-000607-33
Duration of Study in the UK
6 years, 1 months, 23 days
Research summary
Varicella-Zoster Virus (VZV) causes two distinct diseases, Varicella (chickenpox) and Herpes Zoster (HZ) (shingles). Shingles occurs when VZV reactivates in the body following the primary infection with chickenpox.
Immunocompromised children, such as those who have received a kidney transplant are at increased risk of reactivation of latent VZV infection causing shingles. It is hoped that vaccinating children in this study, will reduce their risk of getting shingles and may prevent renal transplant rejection associated with HZ.
GSK has licensed a vaccine, "Shingrix" for the prevention of shingles in adults (50yrs+). In a study of immunosuppressed adults, "Shingrix" offered some protection against shingles. Shingrix has been evaluated in a Phase III immunogenicity study in renal transplant patients (18yrs+) and no safety concerns were reported.
This study is the first in paediatrics and evaluates the safety, reactogenicity and immunogenicity of a new paediatric formula which contains the same piece of VZV as "Shingrix", but has a different adjuvant, appropriate for younger age groups.
184 renal transplant recipients (1-17yrs) will be recruited in Europe. In the UK, approximately 64 subjects will be enrolled in 7 centres. Recruitment will be staggered: the older age group (12-17yrs) being recruited first, then the younger age group (1-11yrs). Safety reviews are scheduled at specified time points. Randomisation is 3:1, active (PED-HZ/su): non-interventional control (no vaccine).
Each subject in the active group will receive two vaccinations, 1-2 months apart with 12 months follow-up. There are eight study visits, of which six require the subject to visit the study site and two are contacts. Blood samples (active group only) will be taken on three occasions and subjects will be asked to complete diary cards. If a subject has an occurrence of HZ, this will be evaluated. The maximum study duration is 16 months.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0312
Date of REC Opinion
28 Jul 2019
REC opinion
Further Information Favourable Opinion