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临床试验/NCT04083430
NCT04083430进行中(未招募)4 期

Cytotoxicity of Yellow Fever Specific CD8 T Cells Following YF-17D Vaccination

University of Aarhus1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 21(+/-3) days after vaccination with YF-17D

研究概览

简要总结

Investigating cytotoxicity of yellow fever specific CD8 T cells following YF-17D vaccination and the following licensing of these epitope-specific CD8 T cells

详细描述

CD: cluster of differentiation YF: yellow fever

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 to 60 years
  • Informed consent given

排除标准

  • Fever (orally >37,5 C) on day of vaccination
  • Immunosuppressants
  • Pregnant or breast feeding
  • Severe immunodeficiency
  • Known thymus dysfunction
  • Allergy against egg
  • Known haemophilia
  • Previous severe reaction to vaccine
  • Not willing to use anticonceptives 4 weeks after vaccination

研究组 & 干预措施

Vaccine

Other

Yellow Fever Vaccine

干预措施: Yellow Fever Vaccine (Drug)

结局指标

主要结局

Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 21(+/-3) days after vaccination with YF-17D

时间窗: 21(+/-3) days

Measured by flow cytometry

Incidence of cytotoxicity of the yellow fever specific (NS4B214LLWNGPMAV222) CD8 T cells 100 (+/- 40) days after vaccination with YF-17D

时间窗: 100 (+/- 40) days

Measured by flow cytometry

次要结局

  • % of patients with novel yellow fever vaccine epitopes according to HLA-type defining optimal timepoint for T cell licensing(100 (+/- 40) days)
  • Proportion of target cells killed ex vivo from in vivo generated YF-specific CD8+ T cells(100 (+/- 40) days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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