NCT00445419

Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Pevion Biotech Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
BIOLOGICAL	PEV2A PEV2B

Timeline

• Start date: 2006-12-01
• Completion: 2008-06-01
• First posted: 2007-03-09
• Last updated: 2010-02-08

Locations

1 site across 1 country: Switzerland