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About
The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' HZ/su vaccine administered on a 0- and 1- to 2-months schedule in adults 18 years of age or older who are receiving chronic immunosuppressive therapy.
Enrollment
Sex
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Volunteers
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:
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:
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.
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.
Use of anti-CD20 or other B-cell monoclonal antibody agents (e.g., rituximab) as induction, maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months (274 days) of first dose of study vaccine/placebo.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine/placebo, or planned use during the study period.
Concurrent or planned participation in another clinical study, at any time during the study period, which has exposed or will expose the subject to an investigational or a non-registered product
Administration or planned administration of a live vaccine within 30 days prior to the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
Planned administration during the study of a varicella or HZ vaccine other than the study vaccine.
Previous vaccination against HZ or varicella within the 12 months preceding the first dose of study vaccine/placebo.
Occurrence of varicella or HZ per clinical history, within the 12 months preceding the first dose of study vaccine/placebo.
Failure to fully complete the 7-day pre-vaccination diary card distributed at the Pre-vaccination visit.
Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of induction and/or maintenance immunosuppressive therapies.
Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
Acute disease and/or fever at the time of vaccination.
Pregnant or lactating female.
Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3.
Primary purpose
Allocation
Interventional model
Masking
265 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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