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NCT00445419 Clinical Trial

Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides

Chronic Hepatitis C Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00445419
Other study ID # PHEPC001
Secondary ID 2006DR1345
Status Completed
Phase Phase 1
First received March 8, 2007
Last updated February 5, 2010
Start date December 2006
Est. completion date June 2008

Study information
Verified date February 2010
Source Pevion Biotech Ltd
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date June 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• PEV2A PEV2B

Locations
Country Name City State
Switzerland Vaccine and Immunotherapy Center, CHUV Lausanne

Sponsors (1)
Lead Sponsor Collaborator
Pevion Biotech Ltd

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse events
Primary Specific cellular immune response by Elispot and FACS
Secondary Specific proliferative response
Secondary Humoral immunity
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