Last updated: 02/23/2019 07:10:41

Safety and immunogenicity of the Zoster vaccine GSK1437173A in elderly subjects

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GSK study ID
108494
See study documents
Clinicaltrials.gov ID
NCT00434577
See results summary
EudraCT ID
2006-004863-69
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: A phase II, single-blind, randomized, controlled, multicentre vaccination study to evaluate the safety and immune response of the GSK Biologicals Zoster vaccine, gE/AS01B, and to compare 3 doses of gE with AS01B adjuvant in healthy elderly subjects, aged 60 to 69 years and 70 years and above.
Trial description: Based on the results of a previous clinical PhaseI/II study, GSK1437173A is the lead GSK candidate Herpes Zoster (HZ) vaccine to prevent episodes of HZ (shingles). This phase II study will be subdivided into a primary study (108494) and three extension studies (108516, 108518 & 108520), consisting of one additional visit each at months 12, 24 and 36, respectively, from the first visit of the Zoster-003 primary study onwards. The aim of the primary 108494 study is to evaluate the immunogenicity & safety of different dosages of the GSK1437173A vaccine in healthy elderly population. The study population will be stratified by age. The primary objective of this trial is to select the best dosage of GSK1437173A. The aim of the extension studies is to evaluate the persistence of the immune response induced by the candidate HZ vaccine during a long term period.
No new subjects will be enrolled during the extension phases of the study.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Frequency of glycoprotein E (gE)-specific cluster of differentiation (CD4) T-cells expressing at least two different activation markers

Timeframe: One month after the second vaccination (Month 3)

Frequency odds ratio of gE-specific CD4 T-cells expressing at least two different activation markers

Timeframe: One month after the second vaccination (Month 3)

Frequency of gE-specific CD4 T-cells expressing at least two different activation markers

Timeframe: One month after the second vaccination (Month 3)

Secondary outcomes:

Frequency of gE-specific CD4 T-cells expressing at least two different activation markers

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Frequency of gE-specific CD4 T-cells expressing IFN-γ and at least another activation marker

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Frequency of gE-specific CD4 T-cells expressing IL-2 and at least another activation marker

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Frequency of gE-specific CD4 T-cells expressing TNF-α and at least another activation marker

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Frequency of gE-specific CD4 T-cells expressing CD40L and at least another activation marker

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Frequency of gE-specific CD8 T-cells expressing at least two different activation markers

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Frequency of gE-specific CD8 T-cells expressing IFN-γ and at least another activation marker

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Frequency of gE-specific CD8 T-cells expressing IL-2 and at least another activation marker

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Frequency of gE-specific CD8 T-cells expressing TNF-α and at least another activation marker

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Frequency of gE-specific CD8 T-cells expressing CD40L and at least another activation marker

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Anti-gE specific antibody concentrations

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Anti-varicella zoster virus (VZV) specific antibody concentrations

Timeframe: At pre-vaccination (Day 0), one month after the first vaccination (Month 2) and second vaccination (Month 3)

Frequency of gE-specific CD4/CD8 T-cells expressing at least two different activation markers

Timeframe: At Months 12, 24 and 36

Frequency of gE-specific CD4/CD8 T-cells expressing IFN-γ and at least another activation marker

Timeframe: At Months 12, 24 and 36

Frequency of gE-specific CD4/CD8 T-cells expressing IL-2 and at least another activation marker

Timeframe: At Months 12, 24 and 36

Frequency of gE-specific CD4/CD8 T-cells expressing TNFα and at least another activation marker

Timeframe: At Month 12, 24 and 36

Frequency of gE-specific CD4/CD8 T-cells expressing CD40L and at least another activation marker

Timeframe: At Month 12, 24 and 36

Anti-gE specific antibody concentrations

Timeframe: At Months 12, 24 and 36

Anti-varicella zoster virus (VZV) specific antibody concentrations

Timeframe: At Months 12, 24 and 36

Frequency of VZV-specific memory B-cells in a subset of subjects

Timeframe: At pre-vaccination (Day 0) and at Month 3

Number of subjects with different biochemical and haematological levels

Timeframe: At Day 0, Month 2 and Month 3

Number of German subjects with different biochemical and haematological levels

Timeframe: At one week post-vaccination 1 (Month 0)

Number of German subjects with different biochemical and haematological levels

Timeframe: At one week post-vaccination 2 (Month 2)

Number of subjects with any and Grade 3 solicited local symptoms

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

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

Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses

Number of subjects with occurrence of clinically diagnosed herpes zoster (HZ) episodes

Timeframe: From Month 0 to Month 3

Number of subjects with occurrence of clinically diagnosed HZ episodes

Timeframe: From Month 3 up to Month 36

Number of subjects with any, Grade 3 and related unsolicited adverse events (AEs)

Timeframe: During the 30-day (Days 0-29) post-vaccination period

Number of subjects with serious adverse events (SAEs)

Timeframe: From Month 0 to Month 3

Number of subjects with serious adverse events (SAEs)

Timeframe: From Month 3 to Month 12

Interventions:
Biological/vaccine: Herpes Zoster vaccine GSK1437173A Low Dose
Biological/vaccine: Herpes Zoster vaccine GSK1437173A Medium Dose
Biological/vaccine: Herpes Zoster vaccine GSK1437173A High Dose
Biological/vaccine: Herpes Zoster vaccine GSK1437173A Modified
Biological/vaccine: Placebo
Enrollment:
715
Observational study model:
Not applicable
Primary completion date:
2007-04-10
Time perspective:
Not applicable
Clinical publications:
Chlibek R et al. (2014) Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 32(15):1745-1753.
Medical condition
Herpes Zoster
Product
GSK1437173A
Collaborators
Not applicable
Study date(s)
February 2007 to July 2010
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
60+ years
Accepts healthy volunteers
Yes
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female aged 60 years or older at the time of the first vaccination.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed.
Inclusion and exclusion criteria
Inclusion criteria:
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • A male or female aged 60 years or older at the time of the first vaccination.
  • Written informed consent obtained from the subject
Exclusion criteria:
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first injection with study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs during the study period, except inhaled and topical steroids are allowed.
  • Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks of the first study vaccine injection, with the exception of the influenza vaccine, which can be administered 1 week preceding or 1 month after the first study vaccine injection.
  • Previous vaccination against HZ.
  • History of herpes zoster (Shingles).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Acute disease at the time of enrolment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by subject's medical history or physical examination as assessed by the investigator.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period.
  • History of or current drug and/or alcohol abuse.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
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Location
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
Status
Study Complete
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Location
GSK Investigational Site
UPPSALA, Sweden, SE-751 85
Status
Study Complete
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Location
GSK Investigational Site
ROTTERDAM, Netherlands, 3011 EN
Status
Study Complete
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Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
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Location
GSK Investigational Site
Berlin, Berlin, Germany, 13347
Status
Study Complete
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Location
GSK Investigational Site
AMSTERDAM, Netherlands, 1018 WT
Status
Study Complete
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Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 01
Status
Study Complete
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Location
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
Status
Study Complete
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Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
Status
Study Complete
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Location
GSK Investigational Site
ESKILSTUNA, Sweden, SE-631 88
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

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
2007-04-10
Actual study completion date
2010-14-07

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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