A Study to Test GlaxoSmithKline's (GSK) Candidate Vaccine-GSK1437173A for Prevention of Shingles in Children With Kidney Transplant

Recruiting now · Phase 1/Phase 2

Conditions studied: Herpes Zoster

In brief

The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of 2 doses of PED-HZ/su, GSK's vaccine candidate for the prevention of Herpes Zoster (HZ) in immunocompromised paediatric renal transplant recipients aged 1-17 years

Key facts

Study ID

NCT04006808

Run by

GlaxoSmithKline

People needed

184

Starts

2019-10-25

Expected to finish

2027-03-31

Last updated by the study team

2026-02-27

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol
• Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
• Written informed assent obtained from the subjects when applicable according to local requirements.
• A male or female between, and including, 1 and 17 years of age at the time of randomisation (Visit Day 1)
• Body weight ≥ 6 kg/13.23 pounds.
• A subject is eligible if they meet at least one of the following criteria:
• Documented previous VZV vaccination OR
• Medically verified varicella (with source documentation) OR
• Seropositive for VZV prior to transplantation.
• Subjects with renal transplant more than six months (180 days) prior randomization (Visit Day 1)
• Subject who has received an ABO compatible allogeneic renal transplant (allograft).
• Subject with stable renal function with stability defined as <20% variability between the last two creatinine measurements or based on investigator opinion after review of multiple creatinine measurements.
• Subject receiving maintenance immunosuppressive therapy for the prevention of allograft rejection for a minimum of one month (30 days) prior to randomization (Visit Day 1).
• Female subjects of childbearing potential may be enrolled in the study, if the subject
• has practiced adequate contraception for 30 days prior to Visit Day 1 and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series

You may not qualify if…

• Medical conditions
• Any primary kidney disease with a high incidence of recurrent primary kidney disease within the allograft
• Evidence of recurrent primary kidney disease within the current allograft
• Previous allograft loss secondary to recurrent primary kidney disease
• History of more than one organ transplanted (that is, kidney-liver, simultaneous double kidney or kidney-other organ(s) transplanted).
• Subjects with an episode of acute allograft rejection over the six months (180 days) prior to enrolment
• Panel Reactive Antibodies (PRA) calculated PRA (cPRA) or Calculated Reaction Frequency (cRF) score that is unknown at the time of transplant
• VZV serostatus unknown prior to transplant
• Subjects with advanced chronic kidney disease
• Evidence of significant proteinuria (≥ 200 g/mol creatinine) believed to be of renal origin (an example of non-renal origin is proteinuria from mucus in a reconstructed bladder)
• Subjects without multiple dialysis options in the event acute or chronic dialysis needed.
• History of unstable or progressive neurological disorder.
• Subjects ≤ 5 years of age with a history of one or more simple or complex febrile seizures
• Subjects > 5 years with history of one or more complex febrile seizures
• Occurrence of a varicella or HZ episode by clinical history within the 6 months (180 days) preceding Visit Day 1
• Any autoimmune disease, with the following exceptions which do not constitute an exclusion criterion:
• IgA nephropathy
• Rapidly progressive glomerulonephritis
• Membranous glomerulonephritis
• Idiopathic Type I membranoproliferative glomerulonephritis
• Diabetes mellitus (type 1 and 2) with diabetic nephropathy
• Confirmed or suspected Human Immunodeficiency Virus or primary immunodeficiency disease
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
• Any condition which, in the judgement of the investigator would make intramuscular injection unsafe.

Where it is running

• GSK Investigational Site — Southampton, United Kingdom (enrolling)
• GSK Investigational Site — Ghent, Belgium (enrolling)
• GSK Investigational Site — Leuven, Belgium (enrolling)
• GSK Investigational Site — Liège, Belgium (enrolling)
• GSK Investigational Site — Bordeaux, France (enrolling)
• GSK Investigational Site — Lille, France (enrolling)
• GSK Investigational Site — Marseille, France (enrolling)
• GSK Investigational Site — Montpellier, France (enrolling)
• GSK Investigational Site — Glasgow Strathclyde, United Kingdom (enrolling)
• GSK Investigational Site — London, United Kingdom (enrolling)
• GSK Investigational Site — Manchester, United Kingdom (enrolling)
• GSK Investigational Site — Nottingham, United Kingdom (enrolling)
• GSK Investigational Site — Brussels, Belgium (enrolling)
• GSK Investigational Site — Paris, France (enrolling)
• GSK Investigational Site — Paris, France (enrolling)
• GSK Investigational Site — Toulouse, France (enrolling)
• GSK Investigational Site — Milan, Italy (enrolling)
• GSK Investigational Site — Padova, Italy (enrolling)
• GSK Investigational Site — Roma, Italy (enrolling)
• GSK Investigational Site — Torino, Italy (enrolling)
• GSK Investigational Site — Gdansk, Poland (enrolling)
• GSK Investigational Site — BaracaldoVizcaya, Spain (enrolling)
• GSK Investigational Site — HebrOn, Spain (enrolling)
• GSK Investigational Site — Madrid, Spain (enrolling)
• GSK Investigational Site — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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