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

Last updated: June 27, 2025
Sponsor: GlaxoSmithKline
Overall Status: Completed

Phase

3

Condition

Shingles

Chickenpox (Varicella Zoster Infection)

Herpes Simplex Infections

Treatment

HZ/su vaccine (GSK1437173A)

Clinical Study ID

NCT04176939
212340
2019-001815-21
  • Ages > 18
  • All Genders

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

Inclusion Criteria:

  • Inclusion criteria for enrolment

  • Subjects who, in the opinion of the investigator, can and will comply with therequirements of the protocol or/and subjects' Legally AcceptableRepresentative(s) [LAR(s)] who, in the opinion of the investigator, can andwill comply, with the requirements of the protocol.

  • Written informed consent obtained from the subject/LAR(s) of the subject priorto 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 allograftrejection for a minimum of one month prior to the first revaccination.

  • Subjects without an episode of allograft rejection within 90 days prior to thefirst revaccination visit.

  • Female subjects of non-childbearing potential may be revaccinated.Non-childbearing potential is defined as pre-menarche, current bilateral tuballigation 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 therevaccination series.

Exclusion

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 expectedto prevent completion of the study.

  • Any other condition that, in the opinion of the investigator, would interfere withthe 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 immunodeficientcondition.

  • History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the vaccine.

  • Any other condition that, in the opinion of the investigator, would interfere withthe evaluations required by the study or make vaccination unsafe.

Prior/Concomitant therapy

  • Administration or planned administration of immunoglobulins and/or any bloodproducts or plasma derivatives during the period starting 3 months before the firstrevaccination 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/ortherapeutic immunosuppressive therapy for the prevention of allograft rejectionwithin 9 months of first revaccination dose of study vaccine.

  • Evidence or high suspicion, in the opinion of the investigator, of noncompliance ornonadherence to use of maintenance immunosuppressive therapies.

  • Planned administration/administration of a live vaccine in the period starting 30days before the first dose and ending 30 days after the last dose of study vaccineadministration.

  • Planned administration/administration of a non-replicating or subunit vaccine, notforeseen by the study protocol, in the period starting 8 days before and ending 30days after each dose of study vaccine.

Other exclusion criteria for revaccination

  • Pregnant or lactating female.

  • Female planning to become pregnant or planning to discontinue contraceptiveprecautions up to 2 months post-revaccination Dose 2.

  • Any condition which, in the judgment of the investigator, would make intramuscularinjection unsafe.

Study Design

Total Participants: 68
Treatment Group(s): 1
Primary Treatment: HZ/su vaccine (GSK1437173A)
Phase: 3
Study Start date:
December 09, 2019
Estimated Completion Date:
June 27, 2024

Connect with a study center

  • GSK Investigational Site

    Brussel, 1090
    Belgium

    Site Not Available

  • GSK Investigational Site

    Bruxelles, 1090
    Belgium

    Site Not Available

  • GSK Investigational Site

    Toronto, Ontario M5G 2N2
    Canada

    Site Not Available

  • GSK Investigational Site

    Helsinki, 00029
    Finland

    Site Not Available

  • GSK Investigational Site

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Panama, 1001
    Panama

    Site Not Available

  • GSK Investigational Site

    Panama City, 1001
    Panama

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08035
    Spain

    Site Not Available

  • GSK Investigational Site

    Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28040
    Spain

    Site Not Available

  • GSK Investigational Site

    Santander, 39008
    Spain

    Site Not Available

  • GSK Investigational Site

    Sevilla, 41013
    Spain

    Site Not Available

  • GSK Investigational Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Tau-Yuan, 333
    Taiwan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.