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

  • STATUS
    Recruiting
  • End date
    Feb 28, 2025
  • participants needed
    184
  • sponsor
    GlaxoSmithKline
Updated on 29 May 2022
renal function
kidney transplant
vaccination
immunosuppression
herpes
varicella
chickenpox

Summary

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

Details
Condition Herpes Zoster
Treatment PED-HZ/su
Clinical Study IdentifierNCT04006808
SponsorGlaxoSmithKline
Last Modified on29 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Subjects without multiple dialysis options in the event acute or chronic dialysis needed
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)
History of unstable or progressive neurological disorder
Subjects > 5 years with history of one or more complex febrile seizures
Subjects ≤ 5 years of age with a history of one or more simple or 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
Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study
Confirmed or suspected Human Immunodeficiency Virus or primary immunodeficiency
disease
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
Atypical Haemolytic Uraemic Syndrome
Prior/Concomitant therapy
Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before Visit Day 1 (Day -29 to Day -1), or planned use during the study period
Subject in receipt of treatment for rejection during the six months (180 days) prior to enrolment
Use of anti-CD20 or other B-cell monoclonal antibody agents within 1 year of Visit Day 1 or planned administration during the duration of the study
Administration of blood products 3 months (90 days) prior to Visit Day 1 or planned administration during the duration of the study
Administration of immunoglobulins 6 months (180 days) prior to Visit Day 1 or planned administration of immunoglobulins during the duration of the study
Administration or planned administration of a vaccine within 30 days prior to Visit Day 1 up to Visit Month 2 with the exception of an inactivated or subunit influenza vaccine which may be given 8 days prior to or 14 days after Visit Day 1 and 8 days prior to or 14 days after Visit Month 1
Previous vaccination against HZ
Varicella vaccination within the 6 months (180 days) preceding Visit Day 1
Planned administration during the study of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine
Prior/Concurrent clinical study experience
• Concurrent or planned participation in another clinical study, at any time during the
available locally through compassionate use programs
study period, in which the subject has been or will be exposed to an investigational or a
submitted for and pending local/country registration
non-investigational product
Other exclusions
approved and registered for use in other countries with well-documented Summary of
Child in care
Product Characteristics or Prescribing Information
Pregnant or lactating female
The name of the active component(s) of these immunosuppressants must be provided in
the concomitant medication listing
Female planning to become pregnant or planning to discontinue contraceptive
Completion is defined as a minimum of 6 days completed
precautions (if of childbearing potential) between one month (30 days) prior to Visit
Any study personnel or their immediate dependants, family, or household member
Day 1 through two months (60 days) after Visit Month 1
Evidence or high suspicion, in the opinion of the investigator, of non-compliance or
non-adherence to use of induction and/or maintenance immunosuppressive therapies
Failure to fully complete the 7-day pre-vaccination diary card distributed at the
Pre-vaccination visit
Completion must cover the 7 days immediately prior to randomisation (Visit Day
)
Subjects with less than 6 days completed may be offered a new date for Visit Day
and the opportunity to comply with the completion of the 7-day pre-vaccination
diary card prior to the new planned Visit Day 1
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