跳至主要内容
临床试验/NCT07097480
NCT07097480招募中不适用

Virus Transmission to People Recently Bitten or With a History of Monkey Bites "SIMVIR"

Institut Pasteur2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年8月14日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
2
主要终点
Study the prevalence of STLV-1 and SFV infections following an NHP bite.

研究概览

简要总结

Nonhuman primates (NHPs) constitute an important reservoir of infectious agents, some of which have emerged in human populations as deadly pathogens. Human exposure to the biological fluids of NHPs - particularly through bites - can result in the transmission of several viruses. Only the rabies virus is currently targeted by post-exposure prophylaxis following an injury caused by an NHP.

The objective of the study is to investigate the prevalence of STLV-1 and SFV infections following a nonhuman primate bite.

详细描述

Nonhuman primates (NHPs) constitute an important reservoir of infectious agents, some of which have emerged in human populations as deadly pathogens. Human exposure to the biological fluids of NHPs - particularly through bites - can result in the transmission of several viruses. Only the rabies virus is currently targeted by post-exposure prophylaxis following an injury caused by an NHP.

Compared to other individuals exposed to nonhuman primates (NHPs), travelers have two unique characteristics. First, they are typically exposed only once to simian infectious agents, in contrast to the repeated exposure experienced by other at-risk groups. If exposure results in an infection event, travelers may spread these infectious agents to geographic areas where they do not normally circulate.

To address the following main objective: to study the prevalence of STLV-1 and SFV infections following a nonhuman primate bite. The study plans to include subjects who have been recently bitten as well as those with a history of nonhuman primate bites. Blood and saliva samples will be collected from the subjects.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Age ≥ 18 years
  • Bite inflicted by an HNP (WHO category 3 level)
  • Written informed consent
  • Affiliation with a social security scheme (excluding State Medical Aid
  • Specific criteria for genetic analyses:
  • Participant has checked the boxes for participation in the genetic component.

排除标准

  • Patient presenting only with scratches inflicted by a PNH
  • Medical management incompatible with the objectives of the study
  • Patient who, in the doctor's opinion, is unlikely to comply with the study protocol
  • Health conditions are incompatible with the sample collection required by the study
  • Patient under legal protection (guardianship or trusteeship)

结局指标

主要结局

Study the prevalence of STLV-1 and SFV infections following an NHP bite.

时间窗: 17 months

Detection of specific antibodies and viral DNA against both viruses in blood.

次要结局

  • Identify risk and demographic factors associated with STLV-1 and SFV infection.(17 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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