Skip to main content
OpenTrials
Completed

NCT Number: NCT01295320

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Herpes Zoster DNA Virus Infections Herpesviridae Infections Infections Varicella Zoster Virus Infection Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Hradec Králové, Czechia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Procedure

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

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Number of Subjects With Any Suspected Cases of HZ Episodes

    Time frame: Month 48 to Month 72

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 14, 2011
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.