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NCT00492648

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

Completed Phase 2 Results posted Last updated 26 June 2019
What this trial tests

Phase 2 trial testing Blood sampling for assay of persistence of immunogenicity in Herpes Zoster in 34 participants. Completed in 23 June 2008.

Timeline
25 June 2007
Primary endpoint
23 June 2008
23 June 2008

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment34
Start date25 June 2007
Primary completion23 June 2008
Estimated completion23 June 2008
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 70, any sex, with Herpes Zoster. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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). Primary · 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.

GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group1184.7± 925.8
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). Primary · 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.

GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group707.4± 533.1
Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). Primary · 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.

GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group899.8± 844.4
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). Primary · 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.

GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group723.8± 816.4
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. Secondary · 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.

gE, IL-2 and IFN-γ/TNF-α/CD40L, Month 30
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group1144.8± 912.2
gE, IFN-γ and IL-2/TNF-α/CD40L, Month 30
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group574.2± 402.7
gE, TNF-α and IFN-γ/IL-2/CD40L, Month 30
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group806.4± 721.1
gE, CD40L and IFN-γ/IL-2/TNF-α, Month 30
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group1173.8± 918.6
gE, IL-2 and IFN-γ/TNF-α/CD40L, Month 42
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group896.9± 822.9
gE, IFN-γ and IL-2/TNF-α/CD40L, Month 42
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group531.5± 533.3
gE, TNF-α and IFN-γ/IL-2/CD40L, Month 42
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group506.5± 550.8
gE, CD40L and IFN-γ/IL-2/TNF-α, Month 42
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group855.5± 769.7
Anti-gE Antibody (Ab) Concentrations Secondary · 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).

At Month 30
GroupValue95% CI
GSK1437173A 18-30 Years Old Group4008.92048.0 – 7847.1
GSK1437173A 50-70 Years Old Group3390.12684.9 – 4280.6
At Month 42
GroupValue95% CI
GSK1437173A 18-30 Years Old Group3662.2905.6 – 14809.0
GSK1437173A 50-70 Years Old Group2413.11698.8 – 3427.8
Anti-VZV Ab Concentrations Secondary · 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).

At Month 30
GroupValue95% CI
GSK1437173A 18-30 Years Old Group5341.82247.8 – 12694.5
GSK1437173A 50-70 Years Old Group4049.33340.0 – 4909.2
At Month 42
GroupValue95% CI
GSK1437173A 18-30 Years Old Group3988.2753.2 – 21115.9
GSK1437173A 50-70 Years Old Group2683.31991.2 – 3615.9
Frequencies of gE-specific Memory B Cells Secondary · At months 30 and 42 after the first vaccination

As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.

At Month 30
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group3614.2± 2389.8
At Month 42
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group2696.1± 2644.0
Frequencies of VZV-specific Memory B Cells Secondary · At months 30 and 42 after the first vaccination

As determined by Enzyme-Linked ImmunoSpot (ELISPOT) assay.

At Month 30
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group4853.8± 3362.1
At Month 42
GroupValue95% CI
GSK1437173A 18-30 Years Old GroupNA± NA
GSK1437173A 50-70 Years Old Group3488.1± 2689.1
Number of Subjects With Any Serious Adverse Events (SAEs) Secondary · 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.

GroupValue95% CI
GSK1437173A 18-30 Years Old Group0
GSK1437173A 50-70 Years Old Group0
Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes Secondary · 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.

GroupValue95% CI
GSK1437173A 18-30 Years Old Group0
GSK1437173A 50-70 Years Old Group0

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A phase 1/2 clinical trial evaluating safety and immunogenicity of a varicella zoster glycoprotein e subunit vaccine candidate in young and older adults.
    Leroux-Roels I, Leroux-Roels G, Clement F, Vandepapelière P, et al · · 2012 · cited 115× · PMID 22872734 · DOI 10.1093/infdis/jis497
  2. An ODE-based mixed modelling approach for B- and T-cell dynamics induced by Varicella-Zoster Virus vaccines in adults shows higher T-cell proliferation with Shingrix than with Varilrix.
    Keersmaekers N, Ogunjimi B, Van Damme P, Beutels P, et al · · 2019 · cited 12× · PMID 30975567 · DOI 10.1016/j.vaccine.2019.03.075

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Other recruiting trials for Herpes Zoster

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00492648.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing