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

Conditions: Herpes Zoster

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.