Last updated: 07/17/2024 17:22:26

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

GSK study ID
204926
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Long term immunogenicity and safety study of GSK Biologicals’ Herpes Zoster subunit (HZ/su) vaccine 1437173A and assessment of re-vaccination with 2 additional doses, in healthy subjects aged 60 years of age and older
Trial description: 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).
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Anti-glycoprotein (gE) specific Antibody (Ab) concentrations

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

Anti-glycoprotein (gE) specific Antibody (Ab) concentrations

Timeframe: 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.

Timeframe: 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.

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

Secondary outcomes:

Anti-glycoprotein (gE) specific Antibody (Ab) concentrations by each age category

Timeframe: 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

Timeframe: 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).

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

Anti-gE specific Antibody (Ab) concentrations

Timeframe: 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.

Timeframe: 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).

Number of subjects with any and Grade 3 solicited local symptoms.

Timeframe: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.

Number of subjects with any, Grade 3 and related solicited general symptoms.

Timeframe: Within 7 days (Days 0-6) after each vaccination and across doses, in the current study.

Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs) according to the Medical Dictionary for Regulatory Activities (MedDRA) classification in all subjects.

Timeframe: Within 30 days (Days 0-29) after each vaccination in the current study.

Number of subjects with any, related and fatal SAEs.

Timeframe: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).

Number of subjects with any and related potential immune-mediated diseases (pIMDs).

Timeframe: From Dose 1 of re-vaccination (Month 120) until study end (Month 134).

Interventions:
  • Biological/vaccine: Herpes Zoster Vaccine GSK1437173A
  • Enrollment:
    70
    Primary completion date:
    2017-28-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Schwarz TF et al. (2018) Persistence of immune response to an adjuvanted varicella-zoster virus subunit vaccine for up to year nine in older adults. Hum Vaccin Immunother. 14(6):1370–1377.
    Andrew Hastie, Grégory Catteau, Adaora Enemuo, Tomas Mrkvan, Bruno Salaun, Stephanie Volpe, Jan Smetana, Lars Rombo, Tino Schwarz, Karlis Pauksens, Caroline Hervé, Adriana Bastidas, Anne Schuind. Immunogenicity of the Adjuvanted Recombinant Zoster Vaccine: Persistence and Anamnestic Response to Additional Doses Administered 10 Years After Primary Vaccination. J Infect Dis. 2020. epublished.
    Medical condition
    Herpes Zoster
    Product
    GSK1437173A
    Collaborators
    Not applicable
    Study date(s)
    April 2016 to October 2018
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    68+ years
    Accepts healthy volunteers
    Yes
    • 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.
    • 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).

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 13347
    Status
    Study Complete
    Location
    GSK Investigational Site
    ESKILSTUNA, Sweden, SE-631 88
    Status
    Study Complete
    Location
    GSK Investigational Site
    Essen, Nordrhein-Westfalen, Germany, 45359
    Status
    Study Complete
    Location
    GSK Investigational Site
    Hradec Kralove, Czech Republic, 500 01
    Status
    Study Complete
    Location
    GSK Investigational Site
    Mannheim, Baden-Wuerttemberg, Germany, 68161
    Status
    Study Complete
    Location
    GSK Investigational Site
    UPPSALA, Sweden, SE-751 85
    Status
    Study Complete
    Showing 1 - 6 of 7 Results

    Study documents

    Clinical study report
    Available language(s): English
    Protocol
    Available language(s): English
    Statistical analysis plan
    Available language(s): English

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2017-28-08
    Actual study completion date
    2018-08-10

    Plain language summaries

    Summary of results in plain language
    Available language(s): English, Czech, German, Swedish

    To view plain language summaries on trialsummaries.com click here.

    Additional information about the trial

    Participate in clinical trial
    Additional information
    IPD for this study will be made available via the Clinical Study Data Request site.
    Click here
    Access to clinical trial data by researchers
    Visit website