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Phase I/IIa Dose Ranging CHRONVAC-C® Study in Chronic HCV Patients

NCT00563173 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2010-02-10

No results posted yet for this study

Summary

The purpose of this study is to evaluate if the DNA vaccine CHRONVAC-C® intended for future treatment of Hepatitis C infections is safe and tolerated when administered to HCV infected individuals with a low viral load. In addition the capability of the vaccine to induce an immune response and the effect on viral load will be studied. In order to increase the uptake of the vaccine the intra muscular injection is combined with electroporation, meaning that a brief electric field is applied to the injection site resulting in temporary pores in the cell membranes that allows the vaccine to enter the cells.

Conditions

  • Chronic Hepatitis C Virus Infection

Interventions

DRUG

CHRONVAC-C®

DNA vaccine, solution for injection, i.m. administration in combination with electroporation

Sponsors & Collaborators

Principal Investigators

  • Ola RH Weiland, Professor · I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden

  • Anders Vahlne, Professor · Tripep AB

  • Matti Sällberg, Professor · Tripep AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00563173 on ClinicalTrials.gov