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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Herpes Zoster

Treatments: Biological: HZ/su vaccine (GSK1437173A)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04176939

212340

2019-001815-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

HZ/su Group

Experimental group

Description:

Participants with renal transplant who completed the 2-dose Herpes Zoster (HZ/su) vaccination course in the primary ZOSTER-041 (NCT02058589) study were enrolled in the current ZOSTER-073 (NCT04176939) study. 47 of these participants further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of the current ZOSTER-073 (NCT04176939) study, first dose at Month 24 and second dose at Month 25.

Treatment:

Biological: HZ/su vaccine (GSK1437173A)