NCT00445419

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

February 8, 2010

Status Verified

February 1, 2010

First QC Date

March 8, 2007

Last Update Submit

February 5, 2010

Conditions

Chronic Hepatitis C

Keywords

Hepatitis CLiver diseaseViral infectionVirosomeVaccinetherapeutic vaccineChronic hepatitis C virus infection

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events

  • Specific cellular immune response by Elispot and FACS

Secondary Outcomes (2)

  • Specific proliferative response

  • Humoral immunity

Interventions

PEV2A PEV2BBIOLOGICAL

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Chronic or acute illness
  • Immunosuppression
  • HCV and/or HBV infection
  • history of allergic disease
  • Pre-existing immune response against peptide of the vaccines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vaccine and Immunotherapy Center, CHUV

Lausanne, 1011, Switzerland

Location

Related Links

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis CLiver DiseasesVirus Diseases

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Giuseppe Pantaleo, MD

    Vaccine and Immunotherapy Center (VIC), Division of Immunology and Allergy, CHUV, Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 8, 2007

First Posted

March 9, 2007

Study Start

December 1, 2006

Study Completion

June 1, 2008

Last Updated

February 8, 2010

Record last verified: 2010-02

Locations

CH(1)