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

Herpes Zoster Clinical Trial

Official title:

Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295320
• Other study ID #: 114825
• Status: Completed
• Phase: Phase 2
• First received: February 11, 2011
• Last updated: October 23, 2017
• Start date: February 28, 2011
• Est. completion date: June 20, 2013

Study information

• Verified date: October 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: June 20, 2013
• Est. primary completion date: June 20, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Procedure:
• Blood sample
Blood sample will be collected at Month 48, Month 60 and Month 72

Locations

Country	Name	City	State
Czechia	GSK Investigational Site	Hradec Kralove
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Essen	Nordrhein-Westfalen
Germany	GSK Investigational Site	Hannover	Niedersachsen
Germany	GSK Investigational Site	Koeln	Nordrhein-Westfalen
Germany	GSK Investigational Site	Mannheim	Baden-Wuerttemberg
Germany	GSK Investigational Site	Wuerzburg	Bayern
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Rotterdam
Sweden	GSK Investigational Site	Eskilstuna
Sweden	GSK Investigational Site	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

Czechia,  Germany,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-?) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-a) 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
Primary	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-?) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-a) 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
Primary	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-?) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-a) 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
Primary	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
Primary	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
Primary	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	Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation	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.	Month 48 to Month 72
Secondary	Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented	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.	Month 0 to Month 72
Secondary	Number of Subjects With Any Fatal SAEs	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.	Month 48 to Month 72
Secondary	Number of Subjects With Any Suspected Cases of HZ Episodes		Month 48 to Month 72
Secondary	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
Secondary	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		Month 48 to Month 72

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