Herpes zoster after recombinant herpes zoster vaccination - Immediate post-RHZ-vaccination evolution of CMI, HMI and lymphocyte count and typing.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study will be the variations and evolution of quantitative values of the 3 parameters over the 3 weeks study period: VZV-specific CMI and quantification, VZV-specific HMI and quantification and Lymphocyte typing
研究概览
简要总结
To investigate the sequential VZV-specific CMI and HMI as well as the lymphocyte typing before and after recombinant HZ vaccination, to better understand the post-vaccination transient specific VZV immunosuppression.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male and female adults between 50 and 65 years of age
- •Willingness to sign the consent form
- •Willingness to the 9 blood samples
- •Willingness to receive the 2 doses of the RHZ vaccine (at 2-6 months interval)
排除标准
- •Intake of any immunosuppressive therapies
- •Contraindication for the RHZ vaccine or one or more of the constituents
- •Pre-menoposal women
- •Any form of immunosuppression
- •Recent live or non-live vaccination(s) (3 months prior to inclusion)
- •Unwillingness to sign the consent form
- •Prior varicella zoster virus vaccination
- •Prior herpes zoster virus vaccination
- •History of prior episode of herpes zoster
- •Active herpes zoster at day 0 of the study
结局指标
主要结局
The primary endpoint of the study will be the variations and evolution of quantitative values of the 3 parameters over the 3 weeks study period: VZV-specific CMI and quantification, VZV-specific HMI and quantification and Lymphocyte typing
The primary endpoint of the study will be the variations and evolution of quantitative values of the 3 parameters over the 3 weeks study period: VZV-specific CMI and quantification, VZV-specific HMI and quantification and Lymphocyte typing
次要结局
未报告次要终点
研究者
Arjen Nikkels
Scientific
Centre hospitalier universitaire de Liege