Immunogenicity and safety of GlaxoSmithKline Biologicals' Herpes Zostersubunit (HZ/su) vaccine in adults 18 years of age or older with renaltransplant.

Phase 1

• Conditions: Herpes Zoster (HZ) and its related complications; MedDRA version: 20.0Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-005059-18-IT
• Lead Sponsor: GLAXOSMITHKLINE BIOLOGICALS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-28
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

- Subjects who, in the opinion of the investigator, can and will comply
with the requirements of the protocol.
- A male or female, aged 18 years or older, and having reached the age
of legal consent, on the date the informed consent is signed. - Written informed consent obtained from the subject.
- Subject who has received an ABO compatible allogeneic renal
transplant.
- Subject receiving maintenance immunosuppressive therapy for the
prevention of allograft rejection for a minimum of one month (30 days)
prior to the first vaccination.
- Subject without an episode of allograft rejection over the previous
three months (90 days) prior to the first vaccination.
- Subject with stable renal function. Stability defined as: - less than
20% variability between last two creatinine measurements or calculated
glomerular filtration rate [GFR]; - or in the opinion of the investigator
after investigator review of more than the last two creatinine
measurements or calculated GFRs.
- Subject not less than 4 months (120 days) and not more than 18
months (547 days) after allograft transplantation at the time of the first
vaccination.
- Subjects with multiple dialysis options (peritoneal and/or more than
one anatomical access site for haemodialysis) in the event acute or
chronic dialysis is needed.
- Female subjects of non-childbearing potential may be enrolled in the
study.
- Female subjects of childbearing potential may be enrolled in the study,
if the subject:
*has practiced adequate contraception for 30 days prior to vaccination,
and
*has a negative pregnancy test on the day of the first vaccination, and
*has agreed to continue adequate contraception during the primary
treatment period and for 2 months after completion of the vaccination
series.
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

- Any primary kidney disease with a high incidence of recurrent primary
kidney disease.
- Evidence of recurrent primary kidney disease within the current
allograft.
- Previous allograft loss secondary to recurrent primary kidney disease.
* Multiple kidney transplants are allowed if the reason for a previous
alograft's loss is not recurrent primary kidney disease.
- More than one organ transplanted (i.e., kidney-liver, double-kidney or
kidney-other organ(s) transplanted).
- History of events that, in the opinion of the investigator, may put
subject at increased risk for chronic allograft dysfunction (e.g., delayed
graft function, peri-operative complications).
- Histologic reports of chronic allograft injury (e.g., transplant
glomerulopathy, arteriopathy, C4d deposition).
- Evidence of significant proteinuria in the opinion of the investigator.
- Panel reactive antibody score (PRA or cPRA) that is unknown at the
time of transplant.
- Any autoimmune or potential immune-mediated disease, including
primary kidney disease.
- Any confirmed or suspected HIV, primary immunodeficiency disease,
disseminated or untreated malignancy, or systemic infection.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified