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

GlaxoSmithKline129 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

129

Conditions

Herpes Zoster

Interventions

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (11)

GSK Investigational Site

Hradec Králové, Czechia

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Hanover, Lower Saxony, Germany

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Amsterdam, Netherlands

GSK Investigational Site

Rotterdam, Netherlands

GSK Investigational Site

Eskilstuna, Sweden

...and 1 more locations

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: Month 60

Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: Month 72

Secondary Outcomes

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.