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

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.