Immunogenicity and Safety Study of Different Formulations of GSK Biologicals' Herpes Zoster Vaccine 1437173A When Administered Twice in Adults Aged 50 Years and Older
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 13
- 主要终点
- Anti-VZV Antibody Concentrations
研究概览
简要总结
The goal of this randomized observer-blind trial is to further refine the formulation of vaccines containing GSK1437173A in older adults by comparing the cellular and humoral immune responses and the safety profiles of the different formulations.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female 50 years of age or above at the time of the first vaccination;
- •Written informed consent obtained from the subject;
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study;
- •If the subject is female, she must be of non-childbearing potential, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period;
- •Chronic administration (defined as more than 14 consecutive days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within one month before the first study vaccination or scheduled within 30 days after study vaccination;
- •Previous vaccination against HZ;
- •Previous vaccination against varicella;
- •History of HZ;
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine;
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy;
- •Administration of immunoglobulins and/or any blood products within the 3 months preceding the first injection of study vaccine or planned administration during the study period;
- •Acute disease at the time of enrolment.
- •Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study;
- •History of or current drug and/or alcohol abuse;
- •Pregnant or lactating female;
- •Female planning to become pregnant or planning to discontinue contraceptive precautions if of childbearing potential.
结局指标
主要结局
Anti-VZV Antibody Concentrations
时间窗: One month after the second vaccination (Month 3)
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Frequency of gE-specific Cluster of Differentiation 4 (CD4+) T-cells Expressing at Least 2 Different Immunological Activation Markers
时间窗: One month after the second vaccination (Month 3)
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Frequency of Varicella-Zoster Virus (VZV)-Specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers
时间窗: One month after the second vaccination (Month 3)
The analysis focused on CD4+ T-cells expressing at least 2 immunological activation markers among Interferon gamma (IFN-γ), Interleukin 2 (IL-2), Tumour Necrosis Factor alpha (TNF-α) and CD40 Ligand (CD40L). Frequencies were determined by in vitro Intracellular Cytokine Staining (ICS).
Anti-glycoprotein E (gE) Antibody Concentrations
时间窗: One month after the second vaccination (Month 3)
Concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
次要结局
- Number of Subjects With Any New Onset of Autoimmune Diseases (NOADs)(During the period after Month 8 up to the end of the study at Month 14)
- Frequencies of gE-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers(At Month 0 and at Month 2)
- Anti-gE Antibody Concentrations(At Month 0 and at Month 2)
- Anti-VZV Antibody Concentrations(At Month 0 and at Month 2)
- Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.(During the 7-day (Days 0-6)post-vaccination period after each dose and across doses)
- Number of Subjects With Serious Adverse Events (SAEs)(During the period after Month 8 up to the end of the study at Month 14)
- Frequency of VZV-specific CD4+ T-cells Expressing at Least 2 Different Immunological Activation Markers(At Month 0 and at Month 2)
- Number of Subjects With Any and Grade 3 Solicited Local Symptoms(During the 7-day (Days 0-6) post-vaccination period after each dose and across doses)
- Number of Subjects With Suspected Cases of Herpes Zoster (HZ)(During the period after Month 8 up to the end of the study at Month 14)
- Number of Subjects With Haematological and Biochemical Parameters Unknown, Below, Within or Above the Normal Ranges(At Month 3)
- Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)(Within the 30-day (Days 0-29) post-vaccination period)