Herpes Zoster

The purpose of this study is 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 will also assess 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.

HZ/su

50μg gE antigen and AS01B Adjuvant

intramuscular injection

0.5

Primary Outcome Measures :
Evaluation of persistence of humoral immunity in terms of anti-glycoprotein E (anti-gE) antibody concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA) at Day 1 in the Long Term Follow Up (LTFU) phase [ Time Frame: At Day 1 ]
Persistence of humoral immunity after the primary vaccination course evaluated in terms of anti-gE antibody concentrations, as determined by ELISA are presented as geometric mean concentrations (GMCs).

Anti-gE antibody concentrations as determined by ELISA at Month 12, in the LTFU phase [ Time Frame: At Month 12 ]
Persistence of humoral immunity after the primary vaccination course evaluated in terms of anti-gE antibody concentrations as determined by ELISA are presented as GMCs.

Anti-gE antibody concentrations as determined by ELISA at Month 24, in the LTFU phase [ Time Frame: At Month 24 ]
Persistence of humoral immunity after the primary vaccination course evaluated in terms of anti-gE antibody concentrations as determined by ELISA are presented as GMCs.

Anti-gE antibody concentrations as determined by ELISA at pre-revaccination, in the revaccination active phase [ Time Frame: At Month 24 (pre-vaccination) ]
Anti-gE antibody concentrations as determined by ELISA are presented as GMCs.

Anti-gE antibody concentrations as determined by ELISA at 1-month post-revaccination dose 1, in the revaccination active phase [ Time Frame: At Month 25 ]
Anti-gE antibody concentrations as determined by ELISA are presented as GMCs.

Anti-gE antibody concentrations as determined by ELISA at 1-month post-revaccination Dose 2 in the revaccination active phase [ Time Frame: At Month 26 ]
Anti-gE antibody concentrations as determined by ELISA are presented as GMCs.

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 ex-posed 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.