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

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

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