Clinical trial NCT01335711: CHRONVAC-C Study Followed by Standard of Care in Chronic Hepatitis C Virus (HCV) Subjects
Official title: A Phase II Open-Label, Randomized, Parallel Group, Safety, Tolerability and Efficacy Study of i.m. Administered CHRONVAC-C in Combination With Electroporation Followed by Standard of Care in Chronic Hepatitis C Virus Genotype 1 Infected and Treatment Naïve Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: ChronTech Pharma AB
Sponsor class: INDUSTRY
Collaborators: name: Inovio Pharmaceuticals
First posted: 2011-04-14
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Early viral kinetics - Second phase slope of viral decline
timeFrame: 0-4 weeks after SOC onset
measure: Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA.
timeFrame: 4 weeks after SOC onset
measure: Partial Early Viral Response (pEVR). Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA.
timeFrame: 12 weeks after SOC onset
measure: Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA.
timeFrame: 12 weeks after SOC onset
Secondary outcomes:
measure: Local tolerance
timeFrame: up to 12 weeks after SOC onset
measure: Change from baseline in vital signs
timeFrame: 0 - 12 weeks
measure: Number of patients with AEs
timeFrame: 12 weeks
measure: Change of blood status from baseline
timeFrame: 0 - 12 weeks
measure: Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response
timeFrame: 0 - 12 weeks
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital
city: Linköping
country: Sweden
facility: Division of Infectious Diseases, Department of Clinical and experimental medicine, Faculty of Health Sciences, Linköping University, Department of Infectious Diseases, County Council of Östergötland
Study officials:
affiliation: I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden
name: Ola RH Weiland, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden
name: Anders G Vahlne, Professor
role: STUDY_CHAIR
affiliation: ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden
name: Matti Sällberg, Professor
role: STUDY_DIRECTOR
References: