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Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01295320
First Posted: February 14, 2011
Last Update Posted: November 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

The subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity.

This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.

The study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.


Condition Intervention Phase
Herpes Zoster Procedure: Blood sample Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells [ Time Frame: Month 48 ]
    -Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)

  • Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells [ Time Frame: Month 60 ]
    Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)

  • Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells [ Time Frame: Month 72 ]
    Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)

  • Antigen-specific Antibody (Ab) Concentrations [ Time Frame: Month 48 ]
    -Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)

  • Antigen-specific Antibody (Ab) Concentrations [ Time Frame: Month 60 ]
    -Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)

  • Antigen-specific Antibody (Ab) Concentrations [ Time Frame: Month 72 ]
    -Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)


Secondary Outcome Measures:
  • Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation [ Time Frame: Month 48 to Month 72 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented [ Time Frame: Month 0 to Month 72 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of Subjects With Any Fatal SAEs [ Time Frame: Month 48 to Month 72 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of Subjects With Any Suspected Cases of HZ Episodes [ Time Frame: Month 48 to Month 72 ]
  • Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented [ Time Frame: Month 48 to Month 72 ]
  • Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented [ Time Frame: Month 48 to Month 72 ]

Enrollment: 129
Actual Study Start Date: February 28, 2011
Study Completion Date: June 20, 2013
Primary Completion Date: June 20, 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1437173A Group
Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577). No treatment was given in this current study (NCT01295320).
Procedure: Blood sample
Blood sample will be collected at Month 48, Month 60 and Month 72

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • Previous participation in study NCT00434577 as a member of the intermediate dose active vaccine group
  • Written informed consent obtained from the subject

Exclusion Criteria:

  • Having participated in another study at any time after NCT00434577 study end in which the subject was exposed to an investigational or non-investigational product or; concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw
  • Having received a vaccine containing some vaccine components, any time after study end of study NCT00434577
  • Having received a vaccine against HZ any time after study end of study NCT00434577
  • Subject who did not receive a complete vaccination course of 2 doses of the intermediate dose active vaccine in study NCT00434577
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01295320


Locations
Czechia
GSK Investigational Site
Hradec Kralove, Czechia, 500 01
Germany
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68161
GSK Investigational Site
Wuerzburg, Bayern, Germany, 97070
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Koeln, Nordrhein-Westfalen, Germany, 51069
GSK Investigational Site
Berlin, Germany, 13347
Netherlands
GSK Investigational Site
Amsterdam, Netherlands, 1018 WT
GSK Investigational Site
Rotterdam, Netherlands, 3011 EN
Sweden
GSK Investigational Site
Eskilstuna, Sweden, SE-631 88
GSK Investigational Site
Uppsala, Sweden, SE-751 85
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 114825
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 114825
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 114825
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 114825
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 114825
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 114825
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 114825
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01295320     History of Changes
Other Study ID Numbers: 114825
First Submitted: February 11, 2011
First Posted: February 14, 2011
Results First Submitted: May 11, 2017
Results First Posted: October 5, 2017
Last Update Posted: November 27, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
URL: http://

Keywords provided by GlaxoSmithKline:
Herpes Zoster
vaccine
safety
immunogenicity

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs