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Sponsored by: |
Pevion Biotech Ltd |
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Information provided by: | Pevion Biotech Ltd |
ClinicalTrials.gov Identifier: | NCT00445419 |
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.
Condition | Intervention | Phase |
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Chronic Hepatitis C |
Biological: PEV2A PEV2B |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |
Vaccine and Immunotherapy Center, CHUV | |
Lausanne, Switzerland, 1011 |
Principal Investigator: | Giuseppe Pantaleo, MD | Vaccine and Immunotherapy Center (VIC), Division of Immunology and Allergy, CHUV, Lausanne |
Study ID Numbers: | PHEPC001, 2006DR1345 |
Study First Received: | March 8, 2007 |
Last Updated: | March 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00445419 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Hepatitis C Liver disease Viral infection Virosome |
Vaccine therapeutic vaccine Chronic hepatitis C virus infection |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Chronic |
Hepatitis, Viral, Human Healthy Hepatitis C Hepatitis C, Chronic |
Virus Diseases Hepatitis RNA Virus Infections Liver Diseases Digestive System Diseases |
Flaviviridae Infections Hepatitis, Chronic Hepatitis, Viral, Human Hepatitis C Hepatitis C, Chronic |