Study to Evaluate Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine at 9 and 10 Years After Vaccine Administration and Assessment of Re-vaccination With 2 Additional Doses at 10 Years After Initial Vaccination, in Healthy Subjects Aged 60 Years of Age(YOA) and Older

NCT02735915 | Completed Phase 3 Results

• 2 other identifiers: 2049262015-004400-30
• Study Type: interventional
• Target: 70
• Locations: 3 countries
• Sites: 7

Brief Summary

The purpose of this study is to evaluate the persistence of immune response to the HZ vaccine as well as safety up to 10 years after the first dose of initial vaccination course. This study will also assess immune responses after re-vaccination with 2 additional doses of the HZ/su administered at ten years after first dose of initial vaccination course from study Zoster-003 (NCT00434577).

Conditions

Herpes Zoster

Keywords

Immunogenicity; Safety; Long term follow-up; Adults; Herpes zoster

Outcome Measures

Primary Outcomes (4)

• Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations

  Anti-glycoprotein E (gE) Ab concentrations were determined by Enzyme-Linked Immunosorbent Assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micro international units per milliliter (mIU/mL).

  At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).

• Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations

  Anti-gE Ab concentrations were determined by ELISA, presented as GMCs and expressed in mIU/mL.

  At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).

• Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.

  gE specific CD4 (2+) T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L, were determined by means of Intracellular Cytokine Staining (ICS) and expressed in T-cells/million cells.

  At Month 108 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).

• Frequencies of gE (Glycoprotein)-Specific Cluster of Differentiation (CD4) (2+) T-cells.

  gE specific CD4 (2+)T-cells expressing at least 2 activation markers among IFN-γ, IL-2, TNF-α and CD40L were determined by means of ICS and expressed in T-cells/million cells.

  At Month 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).

Secondary Outcomes (10)

• Anti-glycoprotein (gE) Specific Antibody (Ab) Concentrations by Each Age Category

  At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).

• Frequencies of Antigen-specific CD4 (2+) T-cells by Each Age Category

  At Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).

• Number of Subjects With Any Serious Adverse Events (SAEs) Related to Study Participation or to a Concurrent GSK Medication/Vaccine (Including GSK1437173A Administered During the Zoster-003 [NCT00434577] Study).

  Between Months 108 and 120 post first dose of initial vaccination course in study Zoster-003 (NCT00434577).

• Anti-gE Specific Antibody (Ab) Concentrations

  At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).

• Frequencies of Antigen-specific CD4 (2+) T-cells, Post Re-vaccination Course.

  At 1 month post each re-vaccination dose (i.e. Month 121 and Month 123) and at 1 year post last re-vaccination dose (i.e., Month 134).

Study Arms (1)

GSK1437173A vaccine Group

EXPERIMENTAL

Subjects who completed vaccination course of 2 doses of HZ/su vaccine (group 50 μg gE/AS01B) in the study Zoster-003 (NCT00434577) were included in this study. 62 of these subjects further received 1 or 2 additional doses of HZ/su vaccine in the revaccination phase of this study

Biological: Herpes Zoster Vaccine GSK1437173A

Interventions

Herpes Zoster Vaccine GSK1437173A BIOLOGICAL

Intramuscular injection

Also known as: HZ/su

GSK1437173A vaccine Group

Eligibility Criteria

• Age: 68 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, ability to have scheduled contacts to allow evaluation during the study). Or subjects with a caregiver who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, vaccination visits, availability for follow-up contacts).
• Written informed consent obtained from the subject prior to performance of any study specific procedure.
• Previous participation in study ZOSTER-003 (NCT00434577), in group 50 µg gE / AS01B, and who completed the vaccination course (2 doses of HZ/su) in study ZOSTER-003 (NCT00434577).
• Subjects are expected to enter the study (or complete Visit 1) as of the time they turn 108 months after first vaccination of previous vaccination course with HZ/su and not later than 111 months.

You may not qualify if:

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first study visit (Day -29 to Day 0), or planned use during the study period.
• Use or anticipated use of immunosuppressants or immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of corticosteroids (\>14 consecutive days of prednisone at a dose of ≥20 mg/day \[or equivalent\]), long-acting immune-modifying agents (e.g., infliximab) or immunosuppressive/cytotoxic therapy (e.g., medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders).
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., malignancy, human immunodeficiency virus \[HIV\] infection).
• Administration or planned administration of a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine, or, administration or planned administration of a non-replicating vaccine\* within 8 days prior to or within 14 days after either dose of study vaccine.
• E.g., inactivated and subunit vaccines, including inactivated and subunit influenza vaccines and pneumococcal conjugate vaccines.
• Previous vaccination against HZ since initial vaccination in Zoster-003.
• Administration of immunoglobulins and/or any blood products during the period starting 3 months before the study start, or planned administration during the study period.
• History of previous HZ.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Hradec Králové, 500 01, Czechia

Location

GSK Investigational Site

Mannheim, Baden-Wurttemberg, 68161, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Essen, North Rhine-Westphalia, 45359, Germany

Location

GSK Investigational Site

Berlin, 13347, Germany

Location

GSK Investigational Site

Eskilstuna, SE-631 88, Sweden

Location

GSK Investigational Site

Uppsala, SE-751 85, Sweden

Location

Related Publications (2)

• Schwarz TF, Volpe S, Catteau G, Chlibek R, David MP, Richardus JH, Lal H, Oostvogels L, Pauksens K, Ravault S, Rombo L, Sonder G, Smetana J, Heineman T, Bastidas A. Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults. Hum Vaccin Immunother. 2018 Jun 3;14(6):1370-1377. doi: 10.1080/21645515.2018.1442162. Epub 2018 Mar 21.

  PMID: 29461919 BACKGROUND

• Hastie A, Catteau G, Enemuo A, Mrkvan T, Salaun B, Volpe S, Smetana J, Rombo L, Schwarz T, Pauksens K, Herve C, Bastidas A, Schuind A. Immunogenicity of the Adjuvanted Recombinant Zoster Vaccine: Persistence and Anamnestic Response to Additional Doses Administered 10 Years After Primary Vaccination. J Infect Dis. 2021 Dec 15;224(12):2025-2034. doi: 10.1093/infdis/jiaa300.

  PMID: 32502272 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Herpes Zoster

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 13, 2016
• Study Start: April 11, 2016
• Primary Completion: August 28, 2017
• Study Completion: October 8, 2018
• Last Updated: April 12, 2024
• Results First Posted: November 1, 2019

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• 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

DE (4); CZ (1); SE (2)