CHRONVAC-C Study Followed by Standard of Care in Chronic Hepatitis C Virus (HCV) Subjects

NCT ID: NCT01335711

Last Updated: 2011-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-06-30

Brief Summary

To explore the effect on early viral kinetics and viral load, and to determine safety, tolerability and anti-viral response for the plasmid DNA vaccine CHRONVAC-C administered i.m. in combination with electroporation followed by standard of care (SOC) in treatment naïve chronic HCV genotype 1 patients.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IMP_C/C IL28B

C/C IL28B subjects to whom IMP will be administrated prior to SOC

Group Type: EXPERIMENTAL

ChronVac-C + SOC

Intervention Type: DRUG

IMP: I.m. administration of 500 μg plasmid DNA vaccine CHRONVAC-C (solution for injection) administered i.m. in combination with electroporation using MedPulser® DDS on 2 occasions with 4 weeks in between followed by standard of care (SOC) initiation after 14 - 42 days.

SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)

SOC_C/C IL28B

C/C IL28B subjects to whom only SOC will be administrated

Group Type: ACTIVE_COMPARATOR

SOC

Intervention Type: DRUG

SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of \< 75 kg and 1200 mg/day for subjects with a BW of \> 75 kg)

IMP_non-C/C IL28B

non-C/C IL28B subjects to whom IMP will be administrated prior to SOC

Group Type: EXPERIMENTAL

ChronVac-C + SOC

Intervention Type: DRUG

IMP: I.m. administration of 500 μg plasmid DNA vaccine CHRONVAC-C (solution for injection) administered i.m. in combination with electroporation using MedPulser® DDS on 2 occasions with 4 weeks in between followed by standard of care (SOC) initiation after 14 - 42 days.

SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)

SOC_non-C/C IL28B

non-C/C IL28B subjects to whom only SOC will be administrated

Group Type: ACTIVE_COMPARATOR

SOC

Intervention Type: DRUG

SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of \< 75 kg and 1200 mg/day for subjects with a BW of \> 75 kg)

Interventions

ChronVac-C + SOC

IMP: I.m. administration of 500 μg plasmid DNA vaccine CHRONVAC-C (solution for injection) administered i.m. in combination with electroporation using MedPulser® DDS on 2 occasions with 4 weeks in between followed by standard of care (SOC) initiation after 14 - 42 days.

SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)

Intervention Type: DRUG

SOC

SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of \< 75 kg and 1200 mg/day for subjects with a BW of \> 75 kg)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male or female subject 18 - 65 years of age with a known chronic hepatitis C infection, being treatment naїve (that is not being earlier treated for HCV infection) and a planned start of standard of care within 12 weeks from screening.
• Known genotype 1 infection.
• Viral load equal to 1000 IU/ml or more
• BMI less than 35.
• Considered probable that the deltoid muscles (left and right) of the subject 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 subject.
• Subject legally competent and able to communicate effectively with the study personnel.
• Subject likely to co-operate and attend the clinic at the appointed times during the study

Exclusion Criteria

• Subject having clinically significant concomitant diseases other than HCV in the medical history to the discretion of the investigator.
• Subject having clinically significant findings on physical examination, vital signs, ECG or clinical laboratory evaluations to the discretion of the investigator.
• Subject having clinical or biochemical signs of cirrhosis.
• Positive hepatitis B surface antigen (HBsAg).
• Positive HIV antigen or antibody test.
• Subject having an ongoing and/or known viral infection other than HCV that requires treatment and/or special medical intention.
• Subject 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. (Corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are allowed, however not on the vaccination area.)
• Immunization within 30 days of the first dose of the study drug.
• Subject 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 allergy or contraindications to interferon and/or ribavirin or their excipients
• 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 subject who is pregnant or breast feeding.
• Female subject 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.
• Female subject with a positive urine pregnancy test.
• Male subject unwilling to use condom for active prevention of pregnancy from first vaccination to 4 months after last injection.
• Subject 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inovio Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

ChronTech Pharma AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ola RH Weiland, Professor

Role: PRINCIPAL_INVESTIGATOR

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

Anders G Vahlne, Professor

Role: STUDY_CHAIR

ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden

Matti Sällberg, Professor

Role: STUDY_DIRECTOR

ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden

Locations

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

Huddinge, , Sweden

Site Status: RECRUITING

Division of Infectious Diseases, Department of Clinical and experimental medicine, Faculty of Health Sciences, Linköping University, Department of Infectious Diseases, County Council of Östergötland

Linköping, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Ola RH Weiland, Professor

Role: CONTACT

ola.weiland@ki.se

+46 (8) 585 800 00

Facility Contacts

Ola RH Weiland, Professor

Role: primary

ola.weiland@ki.se

+46 (8) 585 800 00

Kristina Cardell, MD

Role: primary

kristina.cardell@lio.se

+46 (0)10 103 00 00

Other Identifiers

2010-022960-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CVC-202

Identifier Type: -

Identifier Source: org_study_id