A Study on the Long-term Efficacy, Safety and Persistence of Immune Response of a Vaccine Against Herpes Zoster in Older Adults

January 17, 2024 updated by: GlaxoSmithKline

A Phase 3b, Open-label, Multi-country, Multi-centre, Long-term Follow-up Study of ZOSTER-049 (Follow-up of ZOSTER-006/022 Studies) to Assess the Prophylactic Efficacy, Safety and Persistence of Immune Response of a Herpes Zoster Subunit Vaccine and Assessment of Persistence of Immune Response and Safety of 1 or 2 Additional Doses Administered in ZOSTER-049 in 2 Subgroups of Older Adults

The purpose of the current ZOSTER-101 long-term follow-up (LTFU) study of ZOSTER-049 (NCT02723773) study, an extension of ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies, is to assess the long-term vaccine efficacy (VE) against Herpes Zoster (HZ) (approximately 11-15 years post primary vaccination in ZOSTER-006/022 studies), persistence of immunogenicity and safety of GSK's Herpes Zoster subunit (HZ/su) vaccine in older adults. The persistence of immunogenicity and safety of 1 or 2 additional doses (0, 2-month schedule) of HZ/su vaccine administered to a small group of participants in ZOSTER-049 study (approximately 5 years after the initial vaccination in ZOSTER-006/022 studies) will also be assessed.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

3038

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Warrawong, New South Wales, Australia, 2502
        • GSK Investigational Site
      • Westmead, New South Wales, Australia, 2145
        • GSK Investigational Site
    • Victoria
      • Geelong, Victoria, Australia, 3220
        • GSK Investigational Site
  • Brazil
      • São Paulo, Brazil, 04266-010
        • GSK Investigational Site
      • São Paulo, Brazil, 05403-000
        • GSK Investigational Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-320
        • GSK Investigational Site
    • Paraná
      • Curitiba, Paraná, Brazil, 80069-900
        • GSK Investigational Site
  • Canada
      • Quebec, Canada, G1W 4R4
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • GSK Investigational Site
      • Victoria, British Columbia, Canada, V8R 6R3
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • GSK Investigational Site
      • Truro, Nova Scotia, Canada, B2N1L2
        • GSK Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M9W 4L6
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M4S 1Y2
        • GSK Investigational Site
    • Quebec
      • Mirabel, Quebec, Canada, J7J 2K8
        • GSK Investigational Site
      • Québec City, Quebec, Canada, G1E 7G9
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1J 2G2
        • GSK Investigational Site
  • Czechia
      • Brno, Czechia, 612 00
        • GSK Investigational Site
      • Ceske Budejovice, Czechia, 370 05
        • GSK Investigational Site
      • Hradec Kralove, Czechia, 500 05
        • GSK Investigational Site
  • Estonia
      • Tallinn, Estonia, 13619
        • GSK Investigational Site
      • Tartu, Estonia, 50106
        • GSK Investigational Site
  • Finland
      • Espoo, Finland, 02230
        • GSK Investigational Site
      • Helsinki, Finland, 00100
        • GSK Investigational Site
      • Helsinki, Finland, 00930
        • GSK Investigational Site
      • Jarvenpaa, Finland, 04400
        • GSK Investigational Site
      • Kokkola, Finland, 67100
        • GSK Investigational Site
      • Oulu, Finland, 90220
        • GSK Investigational Site
      • Pori, Finland, 28100
        • GSK Investigational Site
      • Seinajoki, Finland, 60100
        • GSK Investigational Site
      • Tampere, Finland, 33100
        • GSK Investigational Site
      • Turku, Finland, 20520
        • GSK Investigational Site
  • France
      • Angers, France, 49000
        • GSK Investigational Site
      • Clermont-Ferrand, France, 63003
        • GSK Investigational Site
      • Laval, France, 53000
        • GSK Investigational Site
      • Murs Erigne, France, 49610
        • GSK Investigational Site
      • Rosiers d'Egletons, France, 19300
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 10787
        • GSK Investigational Site
      • Hamburg, Germany, 22143
        • GSK Investigational Site
      • Hamburg, Germany, 22415
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Wangen, Baden-Wuerttemberg, Germany, 88239
        • GSK Investigational Site
      • Weinheim, Baden-Wuerttemberg, Germany, 69469
        • GSK Investigational Site
    • Bayern
      • Rednitzhembach, Bayern, Germany, 91126
        • GSK Investigational Site
      • Wallerfing, Bayern, Germany, 94574
        • GSK Investigational Site
    • Hessen
      • Floersheim, Hessen, Germany, 65439
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45355
        • GSK Investigational Site
      • Essen, Nordrhein-Westfalen, Germany, 45359
        • GSK Investigational Site
      • Goch, Nordrhein-Westfalen, Germany, 47574
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Germany, 51069
        • GSK Investigational Site
      • Witten, Nordrhein-Westfalen, Germany, 58455
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55116
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01097
        • GSK Investigational Site
      • Freiberg, Sachsen, Germany, 09599
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
        • GSK Investigational Site
  • Hong Kong
      • Shatin, Hong Kong, 000000
        • GSK Investigational Site
  • Italy
    • Liguria
      • Genova, Liguria, Italy, 16132
        • GSK Investigational Site
    • Lombardia
      • Milano, Lombardia, Italy, 20127
        • GSK Investigational Site
  • Japan
      • Fukuoka, Japan, 812-0025
        • GSK Investigational Site
      • Fukuoka, Japan, 810-0021
        • GSK Investigational Site
      • Fukuoka, Japan, 813-8588
        • GSK Investigational Site
      • Fukuoka, Japan, 816-0864
        • GSK Investigational Site
      • Kanagawa, Japan, 224-8503
        • GSK Investigational Site
      • Tokyo, Japan, 142-8666
        • GSK Investigational Site
  • Korea, Republic of
      • Ansan, Korea, Republic of, 425-707
        • GSK Investigational Site
      • Bucheon-si,, Korea, Republic of, 420-767
        • GSK Investigational Site
      • Incheon, Korea, Republic of, 400-711
        • GSK Investigational Site
      • Kangwon-do, Korea, Republic of, 220-701
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 152-703
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 150-950
        • GSK Investigational Site
  • Mexico
      • Durango, Mexico, 34000
        • GSK Investigational Site
  • Spain
      • Balenyà (Barcelona), Spain, 08550
        • GSK Investigational Site
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Barcelona, Spain, 8025
        • GSK Investigational Site
      • Centelles (Barcelona), Spain, 08540
        • GSK Investigational Site
      • La Roca del Vallès, Spain, 08430
        • GSK Investigational Site
      • Madrid, Spain, 28046
        • GSK Investigational Site
      • Majadahonda( Madrid, Spain, 28222
        • GSK Investigational Site
      • Marid, Spain, 28040
        • GSK Investigational Site
      • Peralada( Girona), Spain, 17491
        • GSK Investigational Site
      • Valencia, Spain, 46020
        • GSK Investigational Site
      • Vic, Spain, 28500
        • GSK Investigational Site
  • Sweden
      • Borås, Sweden, SE-506 30
        • GSK Investigational Site
      • Göteborg, Sweden, SE-413 45
        • GSK Investigational Site
      • Karlskrona, Sweden
        • GSK Investigational Site
      • Linköping, Sweden, SE-58758
        • GSK Investigational Site
      • Malmö, Sweden, SE-211 52
        • GSK Investigational Site
      • Stockholm, Sweden
        • GSK Investigational Site
      • Upplands Väsby, Sweden, SE-194 61
        • GSK Investigational Site
      • Uppsala, Sweden, SE-751 85
        • GSK Investigational Site
      • Örebro, Sweden, SE-703 62
        • GSK Investigational Site
  • Taiwan
      • Taichung, Taiwan, 40447
        • GSK Investigational Site
      • Taipei, Taiwan, 112
        • GSK Investigational Site
      • Taipei, Taiwan, 10002
        • GSK Investigational Site
      • Taoyuan County, Taiwan, 333
        • GSK Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT7 2EB
        • GSK Investigational Site
      • Broughshane, United Kingdom, BT42 4JP
        • GSK Investigational Site
      • Liverpool, United Kingdom, L22 0LG
        • GSK Investigational Site
    • Lancashire
      • Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
        • GSK Investigational Site
    • Wiltshire
      • Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
        • GSK Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • GSK Investigational Site
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • GSK Investigational Site
      • Hickory, North Carolina, United States, 28601
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • GSK Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • GSK Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants and participant's caregiver, who, in the opinion of the investigator, can and are willing to comply with the requirements of the protocol.
  • Written or witnessed/thumb printed informed consent obtained from the participant prior to performance of any study-specific procedure.
  • Medically stable participants as established by medical history and clinical examination before entering into the study.
  • Participants who completed ZOSTER-049 study (following at least 1 dose of HZ/su in ZOSTER-006/022 studies).

Exclusion Criteria:

Medical conditions

  • Any clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant therapy

  • Use of any investigational or non-registered product (drug, vaccine or medical device) for the treatment of HZ or Varicella Zoster Virus (VZV) infection at the time of enrolment or their planned use during the study period.
  • Previous vaccination against VZV or HZ and/or planned administration during the study of a VZV or HZ vaccine (including an investigational or non-registered vaccine other than HZ/su administered in studies ZOSTER-006/022 or ZOSTER-049).

Prior/Concurrent clinical study experience

  • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device) for the prevention and/or treatment of HZ or VZV and which may have a possible activity against VZV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: LTFU Group
Participants who received at least one dose of the HZ/su vaccine in the ZOSTER-006/022 primary studies and are followed for long-term vaccine efficacy and safety in the current ZOSTER-101 study.
Biological: HZ/su vaccine
No study intervention is administered in this extension study. Participants received the HZ/su vaccine administered in the ZOSTER-049 (NCT02723773), ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies. In order to assess the persistence of immune responses, participants provide blood samples at Day 1 and yearly from Month 12 until Month 48 in the current ZOSTER-101 study, according to their study group assignment. In case of a suspected HZ case diagnosis in any of the participants, clinical specimens from HZ lesions (3 replicate samples, collected on the same day, per participant) are collected to confirm the diagnosis of HZ by Polymerase Chain Reaction (PCR)
Other: 1-Additional Dose Group
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and one additional dose of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study.
Biological: HZ/su vaccine
No study intervention is administered in this extension study. Participants received the HZ/su vaccine administered in the ZOSTER-049 (NCT02723773), ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies. In order to assess the persistence of immune responses, participants provide blood samples at Day 1 and yearly from Month 12 until Month 48 in the current ZOSTER-101 study, according to their study group assignment. In case of a suspected HZ case diagnosis in any of the participants, clinical specimens from HZ lesions (3 replicate samples, collected on the same day, per participant) are collected to confirm the diagnosis of HZ by Polymerase Chain Reaction (PCR)
Other: Revaccination Group
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and two additional doses of the HZ/su vaccine in the ZOSTER-049 study and are followed for persistence of immunogenicity and safety in the current ZOSTER-101 study.
Biological: HZ/su vaccine
No study intervention is administered in this extension study. Participants received the HZ/su vaccine administered in the ZOSTER-049 (NCT02723773), ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies. In order to assess the persistence of immune responses, participants provide blood samples at Day 1 and yearly from Month 12 until Month 48 in the current ZOSTER-101 study, according to their study group assignment. In case of a suspected HZ case diagnosis in any of the participants, clinical specimens from HZ lesions (3 replicate samples, collected on the same day, per participant) are collected to confirm the diagnosis of HZ by Polymerase Chain Reaction (PCR)
Other: Control Group
Participants who received two doses of the HZ/su vaccine in the ZOSTER-006/022 primary studies and no additional doses of the HZ/su vaccine in the ZOSTER-049 study, but who served as a control for the two groups that received 1 or 2 additional doses of HZ/su (1-Additional Dose and Revaccination groups). In the current ZOSTER-101 study, this Control group is used in the evaluation of the long-term vaccine efficacy, safety and as a control for persistence of immunogenicity to additional doses administered in ZOSTER-049 study.
Biological: HZ/su vaccine
No study intervention is administered in this extension study. Participants received the HZ/su vaccine administered in the ZOSTER-049 (NCT02723773), ZOSTER-006 (NCT01165177) and ZOSTER-022 (NCT01165229) primary studies. In order to assess the persistence of immune responses, participants provide blood samples at Day 1 and yearly from Month 12 until Month 48 in the current ZOSTER-101 study, according to their study group assignment. In case of a suspected HZ case diagnosis in any of the participants, clinical specimens from HZ lesions (3 replicate samples, collected on the same day, per participant) are collected to confirm the diagnosis of HZ by Polymerase Chain Reaction (PCR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants in LTFU and Control groups with confirmed HZ cases
Time Frame: During the total duration of ZOSTER-101 study (Day 1 through Month 48)

A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis.

A suspected case of HZ can be confirmed in two ways:

  • By PCR;
  • By the HZ Ascertainment Committee (HZAC).
During the total duration of ZOSTER-101 study (Day 1 through Month 48)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants in LTFU and Control groups with confirmed HZ cases
Time Frame: From 1-month post-Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study at Month 48

A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis.

A suspected case of HZ can be confirmed in two ways:

  • By PCR;
  • By the HZAC.
From 1-month post-Dose 2 in the ZOSTER-006/022 studies until the end of the ZOSTER-101 study at Month 48
Anti-glycoprotein E (gE) antibody concentrations
Time Frame: At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study
Anti-gE antibody concentrations are expressed as geometric mean concentrations (GMCs), as determined by enzyme-linked immunosorbent assay (ELISA).
At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study
Frequency of gE-specific Cluster of Differentiation (CD)4+ T-cells secreting at least two activation markers from among IFN-γ, IL-2, TNF-α, CD40L
Time Frame: At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study
At Day 1, Months 12, 24, 36 and 48 in the ZOSTER-101 study
Percentage of participants with serious adverse events (SAEs) causally related to the study intervention
Time Frame: During the total duration of the ZOSTER-101 study (Day 1 through Month 48)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity. Relationship between study intervention and the occurrence of SAEs is assessed by the investigator using clinical judgement.
During the total duration of the ZOSTER-101 study (Day 1 through Month 48)
Percentage of participants with potential immune-mediated diseases (pIMDs) (serious and non-serious) causally related to the study intervention
Time Frame: During the total duration of the ZOSTER-101 study (Day 1 through Month 48)
pIMDs are a subset of adverse events of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. A serious pIMD is any pIMD that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity. Relationship between study intervention and the occurrence of pIMDs is assessed by the investigator using clinical judgement.
During the total duration of the ZOSTER-101 study (Day 1 through Month 48)
Percentage of participants with HZ-related complications of confirmed HZ
Time Frame: During the total duration of the ZOSTER-101 study (Day 1 through Month 48)

A suspected case of HZ is defined as new unilateral rash accompanied by pain (broadly defined to include allodynia, pruritus or other sensations) and no alternative diagnosis.

A suspected case of HZ can be confirmed in two ways:

  • By PCR;
  • By the HZAC. HZ complications are the following: post-herpetic neuralgia, HZ vasculitis, disseminated disease, ophthalmic disease, neurologic disease, visceral disease or stroke A.
During the total duration of the ZOSTER-101 study (Day 1 through Month 48)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2022

Primary Completion (Estimated)

August 23, 2027

Study Completion (Estimated)

August 23, 2027

Study Registration Dates

First Submitted

May 9, 2022

First Submitted That Met QC Criteria

May 9, 2022

First Posted (Actual)

May 12, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 17, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 217917
  • 2021-005319-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD for this study will be made available via the Clinical Study Data Request site.

IPD Sharing Time Frame

IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.

IPD Sharing Access Criteria

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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