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

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.