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

Chronic Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01335711
• Other study ID #: CVC-202
• Secondary ID: 2010-022960-10
• Status: Recruiting
• Phase: Phase 2
• First received: April 13, 2011
• Last updated: October 11, 2011
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: October 2011
• Source: ChronTech Pharma AB
• Contact: Ola RH Weiland, Professor
• Phone: +46 (8) 585 800 00
• Email: ola.weiland[@]ki.se
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female subject 18 - 65 years of age with a known chronic hepatitis C infection, being treatment na?ve (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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• ChronVac-C + SOC
IMP: I.m. administration of 500 µg plasmid DNA vaccine CHRONVAC-C (solution for injection) administered i.m. in combination with electroporation using MedPulser® DDS on 2 occasions with 4 weeks in between followed by standard of care (SOC) initiation after 14 - 42 days. SOC: Peg-IFN-a-2a (180 µg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)
• SOC
SOC: Peg-IFN-a-2a (180 µg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)

Locations

Country	Name	City	State
Sweden	I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital	Huddinge
Sweden	Division of Infectious Diseases, Department of Clinical and experimental medicine, Faculty of Health Sciences, Linköping University, Department of Infectious Diseases, County Council of Östergötland	Linköping

Sponsors (2)

Lead Sponsor	Collaborator
ChronTech Pharma AB	Inovio Pharmaceuticals

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early viral kinetics - Second phase slope of viral decline		0-4 weeks after SOC onset	No
Primary	Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA.		4 weeks after SOC onset	No
Primary	Partial Early Viral Response (pEVR). Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA.		12 weeks after SOC onset	No
Primary	Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA.		12 weeks after SOC onset	No
Secondary	Local tolerance	Local tolerance will be measured for subjects randomized to vaccination. Local tolerance will be measured 3 times during a time period of 2 h post vaccination. The site of injection will also be inspected at the following visits.	up to 12 weeks after SOC onset	Yes
Secondary	Change from baseline in vital signs		0 - 12 weeks	Yes
Secondary	Number of patients with AEs		12 weeks	Yes
Secondary	Change of blood status from baseline		0 - 12 weeks	Yes
Secondary	Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response		0 - 12 weeks	Yes