immunogenicity and safety of glaxosmithkline (gsk) biologicals' herpes zoster subunit (hz/su) vaccine in adults 18 years of age or older with renal transplant

Conditions: 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.

Keywords: immunocompromised safety ≥ 18 years of age renal transplant adults immunosuppressed immunogenicity herpes zoster