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

• Status: Unknown status
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ChronTech Pharma AB
• Collaborator: Inovio Pharmaceuticals

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.