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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 C
Hepatitis, Chronic
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 October 01, 2014