CHRONVAC-C Study Followed by Standard of Care in Chronic... | NCT01335711

NCT01335711

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2010-022960-10	EudraCT Number

Status Module

Name	Class
Inovio Pharmaceuticals	INDUSTRY

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IMP_C/C IL28B	Experimental	C/C IL28B subjects to whom IMP will be administrated prior to SOC	Drug: ChronVac-C + SOC
SOC_C/C IL28B	Active Comparator	C/C IL28B subjects to whom only SOC will be administrated	Drug: SOC
IMP_non-C/C IL28B	Experimental	non-C/C IL28B subjects to whom IMP will be administrated prior to SOC	Drug: ChronVac-C + SOC
SOC_non-C/C IL28B	Active Comparator	non-C/C IL28B subjects to whom only SOC will be administrated	Drug: SOC

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ChronVac-C + SOC	Drug	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)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Early viral kinetics - Second phase slope of viral decline		0-4 weeks after SOC onset
Rapid Viral Response (RVR). Percent subjects reaching non-detectable level of HCV-RNA.		4 weeks after SOC onset
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
Complete Early Viral Response (cEVR). Percent subjects reaching non-detectable level of HCV-RNA.		12 weeks after SOC onset

Secondary Outcomes

Measure	Description	Time Frame
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
Change from baseline in vital signs

Eligibility Module

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.

Name	Affiliation	Role
Ola RH Weiland, Professor	I73 Department of Infectious Diseases, Karolinska Institute, Karolinska University Hospital, Huddinge, Sweden	Principal Investigator
Anders G Vahlne, Professor	ChronTech Pharma AB, Hälsovägen 7, SE-141 57 Huddinge, Sweden

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections