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

NCT05371080 | Active Not Recruiting Phase 3 FDA Drug

• 2 other identifiers: 2179172021-005319-30
• Study Type: interventional
• Target: 3,038
• Locations: 17 countries
• Sites: 105

Brief Summary

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.

Conditions

Herpes Zoster

Keywords

Shingles; Herpes Zoster subunit vaccine; Recombinant Zoster Vaccine (RZV); Long-term follow-up study; Long-term vaccine efficacy; Prophylactic efficacy; Safety; Persistence of immune response; Older adults

Outcome Measures

Primary Outcomes (1)

• Number of participants in LTFU and Control groups with confirmed HZ cases

  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 Outcomes (6)

• Number of participants in LTFU and Control groups with confirmed HZ cases

  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

  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

  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

  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

  During the total duration of the ZOSTER-101 study (Day 1 through Month 48)

Study Arms (4)

LTFU Group

OTHER

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

1-Additional Dose Group

OTHER

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

Revaccination Group

OTHER

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

Control Group

OTHER

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

Interventions

HZ/su vaccine BIOLOGICAL

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)

1-Additional Dose Group; Control Group; LTFU Group; Revaccination Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (107)

GSK Investigational Site

Phoenix, Arizona, 85020, United States

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GSK Investigational Site

Elkridge, Maryland, 21075, United States

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Charlotte, North Carolina, 28209, United States

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GSK Investigational Site

Hickory, North Carolina, 28601, United States

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Pittsburgh, Pennsylvania, 15236, United States

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Bristol, Tennessee, 37620, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84106, United States

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Warrawong, New South Wales, 2502, Australia

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Westmead, New South Wales, 2145, Australia

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GSK Investigational Site

Geelong, Victoria, 3220, Australia

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Belo Horizonte, Minas Gerais, 30150-320, Brazil

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Curitiba, Paraná, 80069-900, Brazil

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São Paulo, 04266-010, Brazil

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GSK Investigational Site

São Paulo, 05403-000, Brazil

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GSK Investigational Site

Vancouver, British Columbia, V5Z 1M9, Canada

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Victoria, British Columbia, V8R 6R3, Canada

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Halifax, Nova Scotia, B3K 6R8, Canada

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Truro, Nova Scotia, B2N1L2, Canada

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Toronto, Ontario, M4S 1Y2, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Québec, Quebec, G1E 7G9, Canada

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Québec, Quebec, G1W 4R4, Canada

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Sherbrooke, Quebec, J1J 2G2, Canada

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GSK Investigational Site

Brno, 612 00, Czechia

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České Budějovice, 370 05, Czechia

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GSK Investigational Site

Hradec Králové, 500 05, Czechia

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GSK Investigational Site

Tallinn, 13619, Estonia

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Tartu, 50106, Estonia

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GSK Investigational Site

Espoo, 02230, Finland

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Helsinki, 00100, Finland

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GSK Investigational Site

Helsinki, 00930, Finland

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GSK Investigational Site

Jarvenpaa, 04400, Finland

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GSK Investigational Site

Kokkola, 67100, Finland

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Oulu, 90220, Finland

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Pori, 28100, Finland

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GSK Investigational Site

Seinäjoki, 60100, Finland

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Tampere, 33100, Finland

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GSK Investigational Site

Turku, 20520, Finland

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GSK Investigational Site

Angers, 49000, France

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GSK Investigational Site

Clermont-Ferrand, 63003, France

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GSK Investigational Site

Laval, 53000, France

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GSK Investigational Site

Mûrs-Erigné, 49610, France

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GSK Investigational Site

Rosiers-d'Égletons, 19300, France

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GSK Investigational Site

Wangen, Baden-Wurttemberg, 88239, Germany

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GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

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GSK Investigational Site

Rednitzhembach, Bavaria, 91126, Germany

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GSK Investigational Site

Wallerfing, Bavaria, 94574, Germany

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GSK Investigational Site

Flörsheim, Hesse, 65439, Germany

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GSK Investigational Site

Cologne, North Rhine-Westphalia, 51069, Germany

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GSK Investigational Site

Essen, North Rhine-Westphalia, 45355, Germany

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Essen, North Rhine-Westphalia, 45359, Germany

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GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

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GSK Investigational Site

Witten, North Rhine-Westphalia, 58455, Germany

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Mainz, Rhineland-Palatinate, 55116, Germany

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Dresden, Saxony, 01097, Germany

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Freiberg, Saxony, 09599, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

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Berlin, 10787, Germany

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Hamburg, 22143, Germany

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Hamburg, 22415, Germany

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GSK Investigational Site

Shatin, 000000, Hong Kong

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GSK Investigational Site

Genoa, Liguria, 16132, Italy

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Milan, Lombardy, 20127, Italy

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GSK Investigational Site

Fukuoka, 810-0021, Japan

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GSK Investigational Site

Fukuoka, 812-0025, Japan

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GSK Investigational Site

Fukuoka, 813-8588, Japan

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GSK Investigational Site

Fukuoka, 816-0864, Japan

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GSK Investigational Site

Kanagawa, 224-8503, Japan

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Tokyo, 142-8666, Japan

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GSK Investigational Site

Durango, 34000, Mexico

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GSK Investigational Site

Ansan, 425-707, South Korea

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GSK Investigational Site

Bucheon-si, 420-767, South Korea

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GSK Investigational Site

Incheon, 400-711, South Korea

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GSK Investigational Site

Kangwon-do, 220-701, South Korea

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GSK Investigational Site

Seoul, 150-950, South Korea

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GSK Investigational Site

Seoul, 152-703, South Korea

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GSK Investigational Site

Balenyà (Barcelona), 08550, Spain

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GSK Investigational Site

Barcelona, 08035, Spain

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GSK Investigational Site

Barcelona, 8025, Spain

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GSK Investigational Site

Centelles (Barcelona), 08540, Spain

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GSK Investigational Site

La Roca del Vallès, 08430, Spain

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GSK Investigational Site

Madrid, 28046, Spain

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GSK Investigational Site

Majadahonda( Madrid, 28222, Spain

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GSK Investigational Site

Marid, 28040, Spain

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GSK Investigational Site

Peralada( Girona), 17491, Spain

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GSK Investigational Site

Valencia, 46020, Spain

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GSK Investigational Site

Vic, 28500, Spain

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GSK Investigational Site

Borås, SE-506 30, Sweden

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GSK Investigational Site

Gothenburg, SE-413 45, Sweden

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GSK Investigational Site

Karlskrona, Sweden

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GSK Investigational Site

Linköping, SE-58758, Sweden

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GSK Investigational Site

Malmo, SE-211 52, Sweden

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GSK Investigational Site

Örebro, SE-703 62, Sweden

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GSK Investigational Site

Stockholm, Sweden

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GSK Investigational Site

Upplands Vasby, SE-194 61, Sweden

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GSK Investigational Site

Uppsala, SE-751 85, Sweden

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GSK Investigational Site

Taichung, 40447, Taiwan

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GSK Investigational Site

Taipei, 10002, Taiwan

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GSK Investigational Site

Taipei, 112, Taiwan

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GSK Investigational Site

Taoyuan, 333, Taiwan

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GSK Investigational Site

Buckshaw Village, Chorley, Lancashire, PR7 7NA, United Kingdom

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GSK Investigational Site

Bradford-on-Avon, Wiltshire, BA15 1DQ, United Kingdom

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GSK Investigational Site

Belfast, BT7 2EB, United Kingdom

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GSK Investigational Site

Broughshane, BT42 4JP, United Kingdom

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GSK Investigational Site

Liverpool, L22 0LG, United Kingdom

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MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Interventional study model and allocation in the current study follow the same approach as presented in the primary studies.

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 12, 2022
• Study Start: August 10, 2022
• Primary Completion (Estimated): August 23, 2027
• Study Completion (Estimated): August 23, 2027
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• 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.

Locations

ES (11); BR (4); DE (17); US (8); GB (5); KR (6); TW (4); ME (1); IT (2); AU (3); HK (1); CZ (3); SE (9); CA (10); FR (5); FI (10); JP (6)