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

NCT00563173 | Unknown Phase 1 DMC

• 2 other identifiers: CVC-201EudraCT No. 2007-002901-33
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• To evaluate safety and tolerability of electroporation mediated i.m. delivery of CHRONVAC-C® in chronically HCV infected, treatment naive patients with low viral load.

  From start of treatment to 24 weeks post treatment

Secondary Outcomes (1)

• To provide information regarding dose related anti-viral immune response and dose related effect on viral load.

  From start of treatment to 24 weeks post treatment

Study Arms (3)

1

OTHER

Low dose

Drug: CHRONVAC-C®

2

OTHER

Medium dose

Drug: CHRONVAC-C®

3

OTHER

High dose

Drug: CHRONVAC-C®

Interventions

CHRONVAC-C® DRUG

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

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patient 18 -65 years of age with a known chronic hepatitis C infection.
• Genotype 1 infection.
• Viral load equal to or less than 800.000 IU/mL.
• BMI less than 30.
• Considered probable that the deltoid muscles (left and right) of the patient will be reached at vaccination using a 12.7 mm cannula for injection and a 15 mm applicator tip for electroporation.
• Written informed consent obtained, and a copy provided to the patient.
• Patient legally competent and able to communicate effectively with the study personnel.
• Patient likely to co-operate and attend the clinic at the appointed times during the study.

You may not qualify if:

• Patient having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.
• Patient having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.
• Patient having clinical or biochemical signs of cirrhosis.
• Positive hepatitis B surface antigen (HBsAg).
• Positive HIV antigen or antibody test.
• Patient having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention.
• Patient having received previous treatment for HCV.
• Radiation therapy or cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose of study drug.
• Treatment with immunomodulating agents such as systemic corticosteroids, IL-2, IFN-alpha, IFN-beta, IFN-gamma within 4 weeks prior to the first dose of study drug.
• Treatment with NSAID within 10 days of the first dose of study drug.
• Immunization within 30 days of the first dose of the study drug.
• Patient having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study drug.
• Prior treatment with DNA therapy.
• Known allergy towards vaccines.
• Known abuse of alcohol, drugs or pharmaceuticals.

Sponsors & Collaborators

• Tripep AB: lead
• Inovio Pharmaceuticals: collaborator

Study Sites (2)

I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge

Stockholm, SE-141 86, Sweden

Location

Department of Gastroenterology and Hepatology, Karolinska University Hospital, Solna

Stockholm, SE-171 76, Sweden

Location

Study Officials

• Ola RH Weiland, Professor

  I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden

  PRINCIPAL INVESTIGATOR

• Anders Vahlne, Professor

  Tripep AB

  STUDY CHAIR

• Matti Sällberg, Professor

  Tripep AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 23, 2007
• First Posted: November 26, 2007
• Study Start: October 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 10, 2010

Record last verified: 2010-02

Locations

SE (2)