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Month 30 & 42 Extension Studies of CRD-004 Primary Study

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.
 
ClinicalTrials.gov Identifier: NCT00492648
Recruitment Status : Completed
First Posted : June 27, 2007
Results First Posted : December 19, 2018
Last Update Posted : June 26, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12 post-vaccination in the primary study. In the extension studies presented here, the persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months after the first vaccination in young and elderly adults who received the GSK324332A vaccine. This protocol posting deals only with objectives & outcome measures of the extension phase at Months 30 and 42. No new recruitment will be done in these extension phases of the primary study. No vaccines are administered in this phase of the study.

Condition or disease Intervention/treatment Phase
Herpes Zoster Procedure: Blood sampling for assay of persistence of immunogenicity Phase 2

Detailed Description:

All subjects in these extension phases of the study were previously vaccinated with the investigational herpes zoster vaccine GSK1437173A. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Further details on the primary study can be found on our GSK study register (https://www.gsk-studyregister.com/advanced-search) by searching on the GSK study identifier 101501.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Extension Study to Evaluate the Persistence of the Immune Responses Induced by GSK Biologicals Zoster Vaccine, GSK324332A, Administered in Healthy Adult Subjects Aged 18-30 Years and 50-70 Years
Actual Study Start Date : June 25, 2007
Actual Primary Completion Date : June 23, 2008
Actual Study Completion Date : June 23, 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: GSK1437173A 18-30 Years Old Group
Subjects aged 18 to 30 years old receiving 2 doses GSK1437173A vaccine in the primary study.
Procedure: Blood sampling for assay of persistence of immunogenicity
Two blood samples: 30 and 42 months after first vaccination

Experimental: GSK1437173A 50-70 Years Old Group
Subjects aged 50 to 70 years old receiving 2 doses GSK1437173A vaccine in the primary study.
Procedure: Blood sampling for assay of persistence of immunogenicity
Two blood samples: 30 and 42 months after first vaccination




Primary Outcome Measures :
  1. Frequencies of Glycoprotein E (gE)-Specific Cluster of Differentiation 4 (CD4) / CD8 T Cells With at Least Two Antigen-specific Cytokines: Interferon Gamma (IFN-γ), Interleukin 2 (IL-2), Tumor Necrosis Factor Alpha (TNF-α), CD 40 Ligand (CD40L). [ Time Frame: At Month 30 after the first vaccination. ]
    The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, and CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected.

  2. Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). [ Time Frame: At Month 30 after the first vaccination ]
    The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected.

  3. Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). [ Time Frame: At Month 42 after the first vaccination ]
    The analysis focused on those gE-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE was performed, since no long-term vaccine effect on gE-specific CD8 T cell response was detected.

  4. Frequencies of Varicella Zoster Virus (VZV)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). [ Time Frame: At Month 42 after the first vaccination ]
    The analysis focused on those VZV-specific CD4 T cells secreting at least two different cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to VZV was performed, since no long-term vaccine effect on VZV-specific CD8 T cell response was detected.


Secondary Outcome Measures :
  1. Frequencies of gE- and VZV-specific CD4/CD8 T Cells With Antigen-specific IFN-γ and/or IL-2 and/or TNF-α and/or CD40L Secretion/Expression. [ Time Frame: At Months 30 and 42 after the first vaccination ]
    The analysis focused on those gE- and VZV-specific CD4 T cells secreting any cytokines among IFN-γ, IL-2, TNF-α, CD40L as determined by intracellular cytokine staining (ICS). No analysis of the immunogenicity data on CD8 T cell response to gE or VZV was performed, since no long-term vaccine effect on gE- and VZV-specific CD8 T cell response was detected.

  2. Anti-gE Antibody (Ab) Concentrations [ Time Frame: At months 30 and 42 after the first vaccination ]
    As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL).

  3. Anti-VZV Ab Concentrations [ Time Frame: At months 30 and 42 after the first vaccination ]
    As determined by the Enzyme-Linked Immunosorbent Assay (ELISA) and expressed as ELISA units per milliliter (EL.U/mL).

  4. Frequencies of gE-specific Memory B Cells [ Time Frame: At months 30 and 42 after the first vaccination ]
    As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.

  5. Frequencies of VZV-specific Memory B Cells [ Time Frame: At months 30 and 42 after the first vaccination ]
    As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.

  6. Number of Subjects With Any Serious Adverse Events (SAEs) [ Time Frame: From Month 30 to study end Month 42 after the first vaccination ]
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of existing hospitalization, result in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.

  7. Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes [ Time Frame: From last primary study visit (Month 12) to study end at Month 42 after the first vaccination. ]
    This assay tabulated the number of subjects with clinically diagnosed HZ episodes, defined as any cutaneous HZ-like rash.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
  • Subjects who successfully completed the primary study and who did not receive Varilrix in the primary study;
  • Written informed consent obtained from the subject;
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 1 month preceding the study start, or planned use during the study period;
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first study procedure, including corticosteroids, except inhaled and topical steroids are allowed;
  • Administration or planned administration of a vaccine not foreseen by the study protocol within 2 weeks before the first study procedure, with the exception of the Influenza vaccine, which can be administered 1 week preceding the first study procedure;
  • Previous vaccination against HZ, except the study vaccine administered in the primary study;
  • History of HZ (shingles);
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination;
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first study procedure or planned administration during the study period.

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): NCT00492648


Locations
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Belgium
GSK Investigational Site
Gent, Belgium, 9000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00492648    
Other Study ID Numbers: 109671
109674
First Posted: June 27, 2007    Key Record Dates
Results First Posted: December 19, 2018
Last Update Posted: June 26, 2019
Last Verified: June 2019
Keywords provided by GlaxoSmithKline:
GSK Biologicals
Varicella Zoster Virus (VZV)
Intracellular cytokine staining (ICS)
Vaccine
Cell mediated immunity (CMI)
Herpes Zoster (HZ)
Shingles
Additional relevant MeSH terms:
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Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases