Phase I Hepatitis C Vaccine Trial of Virosome-Formulated Peptides - Full Text View

Sponsored by:	Pevion Biotech Ltd
Information provided by:	Pevion Biotech Ltd
ClinicalTrials.gov Identifier:	NCT00445419

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 I

MedlinePlus related topics: Hepatitis Hepatitis C

U.S. FDA Resources

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

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
Estimated 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

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

Keywords provided by Pevion Biotech Ltd:

Hepatitis C
Liver disease
Viral infection
Virosome

Vaccine
therapeutic vaccine
Chronic hepatitis C virus infection

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic

Hepatitis, Viral, Human
Healthy
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases

Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on May 06, 2009