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Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides

This study has been completed.
Sponsor:
Information provided by:
Pevion Biotech Ltd
ClinicalTrials.gov Identifier:
NCT00445419
First received: March 8, 2007
Last updated: February 5, 2010
Last verified: February 2010
History of Changes
  Purpose

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
Chronic Hepatitis C
 Biological: PEV2A PEV2B
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pevion Biotech Ltd:

Primary Outcome Measures:
  • Incidence of adverse events
  • Specific cellular immune response by Elispot and FACS

Secondary Outcome Measures:
  • Specific proliferative response
  • Humoral immunity

Estimated Enrollment: 30
Study Start Date: December 2006
Study Completion Date: June 2008
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445419

Locations
Switzerland
Vaccine and Immunotherapy Center, CHUV
Lausanne, Switzerland, 1011
Sponsors and Collaborators
Pevion Biotech Ltd
Investigators
Principal Investigator: Giuseppe Pantaleo, MD Vaccine and Immunotherapy Center (VIC), Division of Immunology and Allergy, CHUV, Lausanne
  More Information

Additional Information:
Click here for more information about this study  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00445419     History of Changes
Other Study ID Numbers: PHEPC001, 2006DR1345
Study First Received: March 8, 2007
Last Updated: February 5, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by Pevion Biotech Ltd:
Hepatitis C
Liver disease
Viral infection
Virosome
 Vaccine
therapeutic vaccine
Chronic hepatitis C virus infection

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 16, 2013