Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT00445419
- Lead Sponsor
- Pevion Biotech Ltd
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- Chronic or acute illness
- Immunosuppression
- HCV and/or HBV infection
- history of allergic disease
- Pre-existing immune response against peptide of the vaccines
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Incidence of adverse events Specific cellular immune response by Elispot and FACS
- Secondary Outcome Measures
Name Time Method Specific proliferative response Humoral immunity
Trial Locations
- Locations (1)
Vaccine and Immunotherapy Center, CHUV
🇨ðŸ‡Lausanne, Switzerland