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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Frequencies of Glycoprotein E (gE)-Specific CD4 / CD8 T Cells With at Least Two Antigen-specific Cytokines (IFN-γ, IL-2, TNF-α, CD40L).
时间窗: 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.
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).
时间窗: 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.
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).
时间窗: 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.
次要结局
- 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.(At Months 30 and 42 after the first vaccination)
- Anti-gE Antibody (Ab) Concentrations(At months 30 and 42 after the first vaccination)
- Anti-VZV Ab Concentrations(At months 30 and 42 after the first vaccination)
- Number of Subjects With Any Serious Adverse Events (SAEs)(From Month 30 to study end Month 42 after the first vaccination)
- Frequencies of gE-specific Memory B Cells(At months 30 and 42 after the first vaccination)
- Number of Subjects With Clinically Diagnosed Herpes Zoster (HZ) Episodes(From last primary study visit (Month 12) to study end at Month 42 after the first vaccination.)
- Frequencies of VZV-specific Memory B Cells(At months 30 and 42 after the first vaccination)