Phase 3 N=68 Prevention

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

Herpes Zoster

Bottom Line

View on ClinicalTrials.gov: NCT04176939 ↗

Enrolled (actual)

Serious AEs

33.8%

Results posted

Dec 2023

Primary outcome: Primary: Anti-glycoprotein E (Anti-gE) Antibody Concentrations, as Assessed in the Long Term Follow-up (LTFU) Phase of the Current ZOSTER-073 Study — 3729.8; 3440.2; 3075.8 mIU/mL

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: HZ/su vaccine (GSK1437173A) (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Aug 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Anti-glycoprotein E (Anti-gE) Antibody Concentrations, as Assessed in the Long Term Follow-up (LTFU) Phase of the Current ZOSTER-073 Study	3729.8; 3440.2; 3075.8	—
PRIMARY Anti-gE Antibody Concentrations, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study	2828.5; 27655.5; 31517.0	—
SECONDARY Frequency of gE-specific Cluster of Differentiation 4 (CD4) (2+) T-cells, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	608.9; 299.4; 711.0	—
SECONDARY Number of Participants With Serious Adverse Events (SAEs) Related to Primary Vaccination in ZOSTER-041 Study, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	—	—
SECONDARY Number of Participants With Suspected or Confirmed Herpes Zoster (HZ) Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	0; 3	—
SECONDARY Number of Participants With Confirmed HZ Cases, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	3	—
SECONDARY Number of Participants With Suspected or Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	0; 5	—
SECONDARY Number of Participants With Biopsy-proven Allograft Rejections, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	2	—
SECONDARY Number of Participants With Allograft Dysfunction Related to Allograft Rejection Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	—	—
SECONDARY Number of Participants With Allograft Dysfunction Related to HZ Episodes, as Assessed in the LTFU Phase of the Current ZOSTER-073 Study	—	—
SECONDARY Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study	793.5; 4476.2; 3747.3	—
SECONDARY Anti-gE Antibody Concentrations, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study	23989.4; 9985.8	—
SECONDARY Frequency of gE-specific CD4(2+) T-cells, as Assessed in the Revaccination Follow-up Phase of the Current ZOSTER-073 Study	1777.4; 1144.9	—
SECONDARY Number of Participants With Any and Grade 3 Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study	9; 0; 6; 0; 37; 7	—
SECONDARY Duration in Days of Solicited Administration Site Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study	4.0; 3.0; 3.0; 3.0; 2.0; 2.5	—
SECONDARY Number of Participants With Any, Grade 3 and Related Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study	26; 2; 22; 23; 2; 21	—
SECONDARY Duration in Days of Solicited Systemic Events After Each Revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study	3.0; 2.0; 2.0; 2.0; 1.0; 1.5	—
SECONDARY Number of Participants With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Post-revaccination, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study	12; 3; 2	—
SECONDARY Number of Participants With Any Serious Adverse Events (SAEs) and Fatal SAEs, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study	9; 1	—
SECONDARY Number of Participants With Related SAEs and Related-fatal SAEs, as Assessed in the Revaccination Active Phase of the Current ZOSTER-073 Study	0; 0	—
SECONDARY Number of Participants With Any and Related Biopsy-proven Allograft Rejections, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	1; 0	—
SECONDARY Number of Participants With Any and Related Potential Immune-mediated Diseases (pIMDs), as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	1; 0	—
SECONDARY Number of Participants With Confirmed HZ Cases, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	—	—
SECONDARY Number of Participants With Allograft Dysfunction Following Revaccination, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	4	—
SECONDARY Number of Participants With Allograft Dysfunction Related to Allograft Rejection, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	—	—
SECONDARY Number of Participants With Allograft Dysfunction Related to HZ Episodes, as Assessed in the Revaccination Active and Follow-up Phases of the Current ZOSTER-073 Study	—	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04176939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.