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

Last updated: December 6, 2022
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

2

Condition

Chickenpox (Varicella Zoster Infection)

Rash

Shingles

Treatment

N/A

Clinical Study ID

NCT04006808
200075
2019-000607-33
  • Ages 1-17
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s) who, in the opinionof 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 localrequirements.
  • A male or female between, and including, 1 and 17 years of age at the time ofrandomisation (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 betweenthe last two creatinine measurements or based on investigator opinion after review ofmultiple creatinine measurements.
  • Subject receiving maintenance immunosuppressive therapy for the prevention ofallograft rejection for a minimum of one month (30 days) prior to randomization (VisitDay 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 hasagreed to continue adequate contraception during the entire treatment period andfor 2 months after completion of the vaccination series

Exclusion

Exclusion Criteria: Medical conditions

  • Any primary kidney disease with a high incidence of recurrent primary kidney diseasewithin 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, simultaneousdouble 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 renalorigin (an example of non-renal origin is proteinuria from mucus in a reconstructedbladder)
  • Subjects without multiple dialysis options in the event acute or chronic dialysisneeded.
  • History of unstable or progressive neurological disorder.
  • Subjects ≤ 5 years of age with a history of one or more simple or complex febrileseizures
  • 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 (180days) preceding Visit Day 1
  • Any autoimmune disease, with the following exceptions which do not constitute anexclusion 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 immunodeficiencydisease
  • Any other clinical condition that, in the opinion of the investigator, might poseadditional risk to the subject due to participation in the study
  • History of any reaction or hypersensitivity likely to be exacerbated by any componentof the vaccine
  • Any condition which, in the judgement of the investigator would make intramuscularinjection unsafe.
  • Atypical Haemolytic Uraemic Syndrome. Prior/Concomitant therapy
  • Use of any investigational or non-registered product other than the study vaccineduring the period starting 30 days before Visit Day 1 (Day -29 to Day -1), or planneduse during the study period.
  • Subject in receipt of treatment for rejection during the six months (180 days) priorto 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 plannedadministration during the duration of the study.
  • Administration of immunoglobulins 6 months (180 days) prior to Visit Day 1 or plannedadministration of immunoglobulins during the duration of the study.
  • Administration or planned administration of a vaccine within 30 days prior to VisitDay 1 up to Visit Month 2 with the exception of an inactivated or subunit influenzavaccine which may be given 8 days prior to or 14 days after Visit Day 1 and 8 daysprior 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 aninvestigational 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 thestudy period, in which the subject has been or will be exposed to an investigational or anon-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 ofProduct Characteristics or Prescribing Information
  • The name of the active component(s) of these immunosuppressants must be provided inthe concomitant medication listing Other exclusions
  • Child in care
  • Pregnant or lactating female
  • Female planning to become pregnant or planning to discontinue contraceptiveprecautions (if of childbearing potential) between one month (30 days) prior to VisitDay 1 through two months (60 days) after Visit Month 1.
  • Evidence or high suspicion, in the opinion of the investigator, of non-compliance ornon-adherence to use of induction and/or maintenance immunosuppressive therapies.
  • Failure to fully complete the 7-day pre-vaccination diary card distributed at thePre-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-vaccinationdiary card prior to the new planned Visit Day 1.
  • Any study personnel or their immediate dependants, family, or household member.

Study Design

Total Participants: 184
Study Start date:
October 25, 2019
Estimated Completion Date:
February 28, 2025

Connect with a study center

  • GSK Investigational Site

    Bordeaux, 33000
    France

    Active - Recruiting

  • GSK Investigational Site

    Lille, 59000
    France

    Active - Recruiting

  • GSK Investigational Site

    Marseille cedex 5, 13385
    France

    Active - Recruiting

  • GSK Investigational Site

    Montpellier cedex, 34295
    France

    Active - Recruiting

  • GSK Investigational Site

    Nantes cedex 1, 44093
    France

    Active - Recruiting

  • GSK Investigational Site

    Paris, 75015
    France

    Active - Recruiting

  • GSK Investigational Site

    Toulouse cedex 9, 31059
    France

    Active - Recruiting

  • GSK Investigational Site

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Genova, Liguria 16147
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Milano, Lombardia 20122
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Padova, Veneto 35128
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Baracaldo/Vizcaya, 48903
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Esplugues De Llobregat. Barcelona, 08950
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Madrid, 28007
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Sevilla, 41013
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Birmingham, B4 6NH
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Cardiff, CF14 4XW
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Glasgow, G51 4TF
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    London, WC1N 3JH
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Nottingham, NG7 2UH
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

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