Immunogenicity and safety of GlaxoSmithKline Biologicals’ Herpes Zoster subunit (HZ/su) vaccine in adults 18 years of age or older with renal transplant
- Conditions
- Herpes Zoster (HZ) and its related complicationsMedDRA version: 18.0Level: PTClassification code 10019974Term: Herpes zosterSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2012-005059-18-FI
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 250
- 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:
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
- 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.
- 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.
- 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 without fever may be enrolled at the discretion of the investigator.
- Pregnant or lactating female.
- Female planning to become pregnant or planning t
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method