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

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:

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.