Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine in Adults 18 Years of Age or Older With Renal Transplant
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: Herpes Zoster vaccine GSK1437173A; Placebo
Intervention description: 2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.; 2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 265.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Immunocompromised; Safety; ≥ 18 years of age; Renal transplant; Adults; Immunosuppressed; Immunogenicity; Herpes zoster

Summary:

      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.
    

Eligibility criteria:

        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
                  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.

        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 allograft'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.

          -  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.

               -  Fever is defined as temperature ≥ 37.5°C /99.5°F by oral route. The preferred
                  route for recording temperature in this study will be oral.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions (if of childbearing potential) before Month 3.