Phase I Hepatitis C Vaccine Trial of Virosome-formulated Peptides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00445419
Recruitment Status : Completed
First Posted : March 9, 2007
Last Update Posted : February 8, 2010
Information provided by:
Pevion Biotech Ltd

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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Biological: PEV2A PEV2B Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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
Study Start Date : December 2006
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Specific proliferative response
  2. Humoral immunity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00445419

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

Additional Information: Identifier: NCT00445419     History of Changes
Other Study ID Numbers: PHEPC001
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: February 8, 2010
Last Verified: February 2010

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

Additional relevant MeSH terms:
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
Immunologic Factors
Physiological Effects of Drugs