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.

Hepatitis C, Liver disease, Viral infection, Virosome, Vaccine, therapeutic vaccine, Chronic hepatitis C virus infection

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