Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides

Pevion Biotech Ltd30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Hepatitis C

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Incidence of adverse events

Specific cellular immune response by Elispot and FACS

Secondary Outcomes

Specific proliferative response

Humoral immunity