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

Primary Purpose

Chronic Hepatitis C

Status

Unknown status

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

ChronVac-C + SOC

SOC

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University HospitalRecruiting
Division of Infectious Diseases, Department of Clinical and experimental medicine, Faculty of Health Sciences, Linköping University, Department of Infectious Diseases, County Council of ÖstergötlandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

IMP_C/C IL28B

SOC_C/C IL28B

IMP_non-C/C IL28B

SOC_non-C/C IL28B

Arm Description

C/C IL28B subjects to whom IMP will be administrated prior to SOC

C/C IL28B subjects to whom only SOC will be administrated

non-C/C IL28B subjects to whom IMP will be administrated prior to SOC

non-C/C IL28B subjects to whom only SOC will be administrated

Outcomes

Primary Outcome Measures

Early viral kinetics - Second phase slope of viral decline

Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA.

Partial Early Viral Response (pEVR). Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA.

Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA.

Secondary Outcome Measures

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.

Change from baseline in vital signs

Number of patients with AEs

Change of blood status from baseline

Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response

Full Information

NCT ID

NCT01335711

First Posted

April 13, 2011

Last Updated

October 11, 2011

Sponsor

ChronTech Pharma AB

Collaborators

Inovio Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01335711

Brief Title

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

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

April 2011 (undefined)

Primary Completion Date

June 2012 (Anticipated)

Study Completion Date

June 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ChronTech Pharma AB

Collaborators

Inovio Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IMP_C/C IL28B

Arm Type

Experimental

Arm Description

C/C IL28B subjects to whom IMP will be administrated prior to SOC

Arm Title

SOC_C/C IL28B

Arm Type

Active Comparator

Arm Description

C/C IL28B subjects to whom only SOC will be administrated

Arm Title

IMP_non-C/C IL28B

Arm Type

Experimental

Arm Description

non-C/C IL28B subjects to whom IMP will be administrated prior to SOC

Arm Title

SOC_non-C/C IL28B

Arm Type

Active Comparator

Arm Description

non-C/C IL28B subjects to whom only SOC will be administrated

Intervention Type

Drug

Intervention Name(s)

ChronVac-C + SOC

Intervention Description

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-α-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)

Intervention Type

Drug

Intervention Name(s)

SOC

Intervention Description

SOC: Peg-IFN-α-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)

Primary Outcome Measure Information:

Title

Early viral kinetics - Second phase slope of viral decline

Time Frame

0-4 weeks after SOC onset

Title

Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA.

Time Frame

4 weeks after SOC onset

Title

Partial Early Viral Response (pEVR). Percent HCV-RNA positive subjects with more than 2 log 10 decline in HCV-RNA.

Time Frame

12 weeks after SOC onset

Title

Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA.

Time Frame

12 weeks after SOC onset

Secondary Outcome Measure Information:

Title

Local tolerance

Description

Time Frame

up to 12 weeks after SOC onset

Title

Change from baseline in vital signs

Time Frame

0 - 12 weeks

Title

Number of patients with AEs

Time Frame

12 weeks

Title

Change of blood status from baseline

Time Frame

0 - 12 weeks

Title

Exploratory Analysis - Characterization and quantification of the vaccine primed NS3-immune response

Time Frame

0 - 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ola RH Weiland, Professor

Phone

+46 (8) 585 800 00

ola.weiland@ki.se

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ola RH Weiland, Professor

Organizational Affiliation

I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Anders G Vahlne, Professor

Organizational Affiliation

ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Matti Sällberg, Professor

Organizational Affiliation

ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden

Official's Role

Study Director

Facility Information:

Facility Name

I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital

City

Huddinge

ZIP/Postal Code

SE-141 86

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ola RH Weiland, Professor

Phone

+46 (8) 585 800 00

ola.weiland@ki.se

First Name & Middle Initial & Last Name & Degree

Ola RH Weiland, Professor

Facility Name

Division of Infectious Diseases, Department of Clinical and experimental medicine, Faculty of Health Sciences, Linköping University, Department of Infectious Diseases, County Council of Östergötland

City

Linköping

ZIP/Postal Code

SE-581 85

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kristina Cardell, MD

Phone

+46 (0)10 103 00 00

kristina.cardell@lio.se

First Name & Middle Initial & Last Name & Degree

Kristina Cardell, MD

12. IPD Sharing Statement

Learn more about this trial

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

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