Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects
Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects
1 other identifier
interventional
129
4 countries
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2011
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 11, 2011
CompletedFirst Posted
Study publicly available on registry
February 14, 2011
CompletedStudy Start
First participant enrolled
February 28, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2013
CompletedResults Posted
Study results publicly available
October 5, 2017
CompletedNovember 27, 2017
October 1, 2017
2.3 years
February 11, 2011
May 11, 2017
October 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
-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)
Month 48
Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
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)
Month 60
Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
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)
Month 72
Antigen-specific Antibody (Ab) Concentrations
-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
Month 48
Antigen-specific Antibody (Ab) Concentrations
-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
Month 60
Antigen-specific Antibody (Ab) Concentrations
-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
Month 72
Secondary Outcomes (6)
Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation
Month 48 to Month 72
Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented
Month 0 to Month 72
Number of Subjects With Any Fatal SAEs
Month 48 to Month 72
Number of Subjects With Any Suspected Cases of HZ Episodes
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
Month 48 to Month 72
- +1 more secondary outcomes
Study Arms (1)
GSK1437173A Group
EXPERIMENTALSubjects 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).
Interventions
Blood sample will be collected at Month 48, Month 60 and Month 72
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (11)
GSK Investigational Site
Hradec Králové, 500 01, Czechia
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Würzburg, Bavaria, 97070, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51069, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359, Germany
GSK Investigational Site
Berlin, 13347, Germany
GSK Investigational Site
Amsterdam, 1018 WT, Netherlands
GSK Investigational Site
Rotterdam, 3011 EN, Netherlands
GSK Investigational Site
Eskilstuna, SE-631 88, Sweden
GSK Investigational Site
Uppsala, SE-751 85, Sweden
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2011
First Posted
February 14, 2011
Study Start
February 28, 2011
Primary Completion
June 20, 2013
Study Completion
June 20, 2013
Last Updated
November 27, 2017
Results First Posted
October 5, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.