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

A Phase I/IIa Open-Label, Dose Ranging, Parallel, Safety, Tolerability and Efficacy Study of i.m. Administered CHRONVAC-C® in Combination With Electroporation in Chronic HCV Genotype 1 Infected and Treatment Naïve Patients With Low Viral Load

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis C Virus Infection
• Intervention / Treatment: Drug: CHRONVAC-C®

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, SE-141 86
    • I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge
  • Stockholm, Sweden, SE-171 76
    • Department of Gastroenterology and Hepatology, Karolinska University Hospital, Solna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• History, signs or symptoms of a cardiac disease.
• Presence of an implantable pacemaker.
• Any metal implants within the treatment areas (close to the right and/or left deltoid muscles).
• Diagnoses of a serious psychiatric illness which may influence study participation.
• Female patient who is breast feeding.
• Female patient not clinically sterile (hysterectomy, tubal ligation or postmenopausal (amenorrhea > 1 year and FSH > 30 mU/ml) OR if not clinically sterile unwilling to use a reliable contraception method.
• Patient with a positive urine pregnancy test.
• Male patient unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection.
• Patient or their immediate families being an investigator or site personnel directly affiliated with this study. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Low dose	Drug: CHRONVAC-C®; DNA vaccine, solution for injection, i.m. administration in combination with electroporation
Other: 2; Medium dose	Drug: CHRONVAC-C®; DNA vaccine, solution for injection, i.m. administration in combination with electroporation
Other: 3; High dose	Drug: CHRONVAC-C®; DNA vaccine, solution for injection, i.m. administration in combination with electroporation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tripep AB
• Collaborators: Inovio Pharmaceuticals
• Investigators: Principal Investigator: Ola RH Weiland, Professor, I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden; Study Chair: Anders Vahlne, Professor, Tripep AB; Study Director: Matti Sällberg, Professor, Tripep AB

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Anticipated): April 1, 2010
• Study Completion (Anticipated): April 1, 2010

Study Registration Dates

• First Submitted: November 23, 2007
• First Submitted That Met QC Criteria: November 23, 2007
• First Posted (Estimate): November 26, 2007

Study Record Updates

• Last Update Posted (Estimate): February 10, 2010
• Last Update Submitted That Met QC Criteria: February 9, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: CVC-201; EudraCT No. 2007-002901-33