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临床试验/NCT00445419
NCT00445419已完成1 期

A Phase I Single-blind Randomised Placebo Controlled Dose Escalating Study of One Virosome Formulated CD4 and Two Virosomes Formulated CD8 Hepatitis C Virus (HCV) Vaccine Components (PEV2A and PEV2B) Administered to Healthy Adult Volunteers

Pevion Biotech Ltd2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2006年12月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Incidence of adverse events

研究概览

简要总结

Pevion Biotech has designed a therapeutic vaccine to treat patients who suffer from chronic hepatitis C virus infection. The vaccine is based on a combination of the PeviPRO and PeviTER platforms using synthetic peptide antigens from the hepatitis C virus. Generally, a cellular immune response by cytotoxic T-lymphocytes (CTL) seems to be crucial in overcoming a hepatitis C virus infection. In-depth research in recent years has shown that the cellular immune response is even more effective when supported by helper T-cells. Pevion Biotech's HCV vaccine candidate utilizes this effect inducing specific CTL responses (PeviTER) together with a supportive helper T cell response (PeviPRO). This virosome-based technological combination in a single product represents a new generation of modular therapeutic vaccines.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy volunteers of both sexes
  • Aged between 18 and 45 years
  • Free of obvious health problems
  • With a BMI between 18.5 and 29.9 are included if they give written informed consent

排除标准

  • Chronic or acute illness
  • Immunosuppression
  • HCV and/or HBV infection
  • history of allergic disease
  • Pre-existing immune response against peptide of the vaccines

结局指标

主要结局

Incidence of adverse events

Specific cellular immune response by Elispot and FACS

次要结局

  • Specific proliferative response
  • Humoral immunity

研究者

发起方
Pevion Biotech Ltd
申办方类型
Industry

研究点 (2)

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