A Study to Test GlaxoSmithKline's (GSK) Herpes Zoster (HZ) Subunit Vaccine's Long-term Immune Response in Previously Vaccinated Kidney Transplant Adults and Then to Test if 2 Additional Doses of the Vaccine Are Safe and Able to Generate an Immune Response
Condition: Herpes Zoster
MeSH terms: Herpes Simplex; Herpes Zoster
Intervention: HZ/su vaccine (GSK1437173A)
Intervention description: 2 intramuscular (IM) doses of the HZ/su vaccine administered - first dose at Month 24 and second dose at Month 25.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the long-term immune responses to the Herpes Zoster
      subunit (HZ/su) vaccine as well as safety up to 7 years after the 2-dose primary vaccination
      course from study ZOSTER-041 (NCT02058589). This study also assessed immune responses as well
      as safety after revaccination with 2 additional doses of the HZ/su administered at 6 to 8
      years after the 2-dose primary vaccination course.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Inclusion criteria for enrolment

               -  Subjects who, in the opinion of the investigator, can and will comply with the
                  requirements of the protocol or/and subjects' Legally Acceptable
                  Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will
                  comply, with the requirements of the protocol.

               -  Written informed consent obtained from the subject/LAR(s) of the subject prior to
                  performance of any study-specific procedure.

               -  Subjects who previously participated in study ZOSTER-041 and completed the full 2
                  dose HZ/su primary vaccination course.

          -  Inclusion criteria for revaccination

               -  Subjects receiving maintenance CIS therapy for the prevention of allograft
                  rejection for a minimum of one month prior to the first revaccination.

               -  Subjects without an episode of allograft rejection within 90 days prior to the
                  first revaccination visit.

               -  Female subjects of non-childbearing potential may be revaccinated.
                  Non-childbearing potential is defined as pre-menarche, current bilateral tubal
                  ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.

               -  Female subjects of childbearing potential may be revaccinated, if the subject:

          -  has practiced adequate contraception for 30 days prior to revaccination, and

          -  has a negative pregnancy test on the day of revaccination, and

          -  has agreed to continue adequate contraception up to 2 months after completion of the
             revaccination series.

        Exclusion Criteria:

        Exclusion criteria for enrolment Medical conditions

          -  Vaccination against HZ since completion of study ZOSTER-041.

          -  Significant underlying illness that, in the opinion of the investigator, is expected
             to prevent completion of the study.

          -  Any other condition that, in the opinion of the investigator, would interfere with the
             evaluations required by the study.

        Prior/Concurrent clinical study experience

        • Concurrently participating in another interventional vaccine or immunosuppressive
        clinical study, in which the subject is exposed to an investigational or a
        non-investigational vaccine/product (drug) at any time during the ZOSTER-073 study.

        Exclusion criteria for revaccination Medical conditions

          -  History of confirmed HZ within one year before revaccination visit (Visit 3).

          -  More than one organ transplanted.

          -  Any additional confirmed or suspected immunosuppressive or immunodeficient condition.

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccine.

          -  Any other condition that, in the opinion of the investigator, would interfere with the
             evaluations required by the study or make vaccination unsafe.

        Prior/Concomitant therapy

          -  Administration or planned administration of immunoglobulins and/or any blood products
             or plasma derivatives during the period starting 3 months before the first
             revaccination dose of study vaccine and ending at Visit 5 (Month 26).

          -  Use of anti-CD20 or other B-cell monoclonal antibody agents as maintenance and/or
             therapeutic immunosuppressive therapy for the prevention of allograft rejection within
             9 months of first revaccination dose of study vaccine.

          -  Evidence or high suspicion, in the opinion of the investigator, of noncompliance or
             nonadherence to use of maintenance immunosuppressive therapies.

          -  Planned administration/administration of a live vaccine in the period starting 30 days
             before the first dose and ending 30 days after the last dose of study vaccine
             administration.

          -  Planned administration/administration of a non-replicating or subunit vaccine, not
             foreseen by the study protocol, in the period starting 8 days before and ending 30
             days after each dose of study vaccine.

        Other exclusion criteria for revaccination

          -  Pregnant or lactating female.

          -  Female planning to become pregnant or planning to discontinue contraceptive
             precautions up to 2 months post-revaccination Dose 2.

          -  Any condition which, in the judgment of the investigator, would make intramuscular
             injection unsafe.