A Reactogenicity, Safety and Immunogenicity Study of GSK's Paediatric Herpes Zoster Subunit Candidate Vaccine (PED-HZ/su) GSK143713A in Immunocompromised Paediatric Renal Transplant Recipients

200075

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

2019-10-25

2024-03-25

2025-02-28

Recruiting

Early phase I

184

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 * 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. * 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 study period, in which the subject has been or will be exposed to an investigational or a non-investigational product * available locally through compassionate use programs, * submitted for and pending local/country registration, * approved and registered for use in other countries with well-documented Summary of Product Characteristics or Prescribing Information * The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication listing Other exclusions * Child in care * Pregnant or lactating female * Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) between one month (30 days) prior to Visit 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 1). * Completion is defined as a minimum of 6 days completed. * Subjects with less than 6 days completed may be offered a new date for Visit Day 1 and the opportunity to comply with the completion of the 7-day pre-vaccination diary card prior to the new planned Visit Day 1. * Any study personnel or their immediate dependants, family, or household member.

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2022-12-07