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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
2017-28-08
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
Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Study Complete

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
Completed
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

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