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

This is an interventional treatment trial for Chronic Hepatitis C Virus Infection Read More

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.