chronvac-c study followed by standard of care in chronic hepatitis c virus (hcv) subjects

Conditions: Chronic Hepatitis C

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.


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.