Long-term Immunogenicity of a Live Attenuated Herpes Zoster Vaccine (Zostavax) in Patients With Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Humoral immune response to vaccine
研究概览
简要总结
A recent randomized controlled trial (RCT) from our group has demonstrated safety and immune response (both humoral and cell-mediated) of the live-attenuated herpes zoster (HZ) vaccine (Zostavax) in stable systemic lupus erythematosus (SLE) patients with a previous history of HZ or varicella infection. An important research question is whether the immunogenicity of the HZ vaccine in SLE patients is long-lasting. There is no information in the literature regarding the long-term immunogenicity and safety of Zostavax in SLE patients. This prompts the current extension study which is planned to evaluate the long-term immunogenicity and efficacy of Zostavax in our original patient cohort.
详细描述
A recent RCT from our group has demonstrated safety and immune response (both humoral and cell-mediated) of the live-attenuated Zostavax in stable SLE patients with a previous history of HZ or varicella infection. An important research question is whether the immunogenicity of the HZ vaccine in SLE patients is long-lasting. There is no information in the literature regarding the long-term immunogenicity and safety of the HZ vaccine, Zostavax, in SLE patients.
Patients who had completed the original RCT and had been followed for 5 years since HZ vaccination or placebo injection were invited to participate in this extension study. Blood samples will be taken for a repeat assessment of the humoral and cell-mediated response to VZV at 5 years.
Outcomes of interest Primary outcome Difference between the two groups in the proportion of patients who have a persistent and 50% increase in IgG to VZV (humoral response to Zostavax) at 5 years compared to baseline Secondary outcomes
- Difference between the two groups in the cell-mediated response to Zostavax at 4 years as compared to baseline
- Vaccine efficacy - difference in the rate of clinical HZ reactivation between two groups of patients at 5 years
- Vaccine safety - difference between the two groups in terms of SLE flares and new autoimmune phenomena at 5 years
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SLE patients who fulfill ≥4 of the 1997 ACR or the 2012 SLICC/ACR criteria for SLE or healthy controls who had participated in the original RCT
- •Age ≥18 years
- •Having completed the original RCT of HZ vaccine vs placebo
- •Having been followed for 5 years since HZ vaccination or placebo injection
- •Willing to comply with all study procedures
排除标准
- •Patients who refuse to participate in this long-term extension study
- •Patients in the placebo group who have subsequently received HZ vaccination
- •Patients who cannot give a written consent (mentally incapable or illiterate)
结局指标
主要结局
Humoral immune response to vaccine
时间窗: 5 years after vaccination
percentage and absolute change in anti-VZV IgG titer from baseline
次要结局
- Cell-mediated immune response to vaccine(5 years after vaccination)
研究者
Chi Chiu Mok
Consultant
Tuen Mun Hospital