Chronic Hepatitis C
Conditions
Keywords
Hepatitis C, Liver disease, Viral infection, Virosome, Vaccine, therapeutic vaccine, Chronic hepatitis C virus infection
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.
Interventions
BIOLOGICALPEV2A PEV2B
Sponsors
Pevion Biotech Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | — |
| Specific cellular immune response by Elispot and FACS | — |
Secondary
| Measure | Time frame |
|---|---|
| Specific proliferative response | — |
| Humoral immunity | — |
Countries
Switzerland
Outcome results
None listed