Phase 2
N=34
Month 30 & 42 Extension Studies of CRD-004 Primary Study
Herpes Zoster
Bottom Line
View on ClinicalTrials.gov: NCT00492648 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: 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). — NA; 1184.7 gE-specific CD4 cells/million CD4 cells
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Blood sampling for assay of persistence of immunogenicity (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
NA; 1184.7 | — |
| PRIMARY 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). |
NA; 723.8 | — |
| PRIMARY Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L). |
NA; 899.8 | — |
| PRIMARY 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). |
NA; 723.8 | — |
| SECONDARY 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. |
NA; 1144.8; NA; 574.2; NA; 806.4 | — |
| SECONDARY Anti-gE Antibody (Ab) Concentrations |
4008.9; 3390.1; 3662.2; 2413.1 | — |
| SECONDARY Anti-VZV Ab Concentrations |
5341.8; 4049.3; 3988.2; 2683.3 | — |
| SECONDARY Frequencies of gE-specific Memory B Cells |
NA; 3614.2; NA; 2696.1 | — |
| SECONDARY Frequencies of VZV-specific Memory B Cells |
NA; 4853.8; NA; 3488.1 | — |
| SECONDARY Number of Subjects With Any Serious Adverse Events (SAEs) |
0; 0 | — |
| SECONDARY Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes |
0; 0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00492648). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.