Study of a Novel Therapeutic Vaccine Against Hepatitis C Using Ad6NSmut and MVA-NSmut in Chronically Infected Patients

NCT01701336 | Completed Phase 1 DMC

• 2 other identifiers: HCV0042010-022700-49
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine whether administration of recombinant IMPs Ad6NSmut and MVA-NSmut (experimental vaccines for hepatitis C) in HCV chronically infected patients in combination with the standard Interferon/ribavirin therapy is safe and induces an immunological response.

Conditions

Hepatitis C

Keywords

Hepatitis; Hepatitis C; HCV; vaccine; adenovirus; MVA; T cells; ELISpot

Outcome Measures

Primary Outcomes (1)

• Number and severity of adverse events

  Safety is assessed by the frequency, incidence and nature of adverse events and serious adverse events arising during the study. Abnormal clinical findings from medical history, examination or blood, will be assessed as to their clinical significance. All AEs occurring during the study observed by the investigator or reported by the patient, whether or not attributed to study medication, will be reported in the CRF. All AEs that result in a patient's withdrawal from the study or that are present at the end of the study, will be followed up until a satisfactory resolution occurs, or until a non-study related causality is assigned.

  6 months

Secondary Outcomes (1)

• IFNγ ELISpot. Unit: IFNγ spot forming cells (SFC)/ million splenocytes

  6 months

Other Outcomes (1)

• HCV-RNA. Unit: viral genomes/ml/ALT

  6 months

Study Arms (1)

Unique Arm

EXPERIMENTAL

* Ad6NSmut * MVA-NSmut 15 subjects receiving 2 doses Ad6NSmut at week 0 and 4, then 2 doses of MVA-NSmut at weeks 8 and 12. PEG-IFN/RBV therapy starts at week 10 after first vaccination

Biological: Ad6NSmut, MVA-NSmut

Interventions

Ad6NSmut, MVA-NSmut BIOLOGICAL

2 doses Ad6NSmut at week 0 and 4, then 2 doses of MVA-NSmut at weeks 8 and 12. PEG-IFN/RBV therapy starts at week 10 after first vaccination

Also known as: Ad6NSmut, MVA-NSmut

Unique Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCV infected with genotype-1 infection, previously treated with PEG-IFN/RBV and belonging to one of the 2 categories (partial responder and relapsers) as described above
• Having terminated previous treatment at least 6 months before enrolment
• Adults aged 18 to 65 years (inclusive)
• Resident in or near the trial sites for the duration of the vaccination study
• Able and willing (in the Investigator's opinion) to comply with all study requirements
• For women of fertile age (with the exception of those not having heterosexual intercourses and of women with vasectomised partners) and for sexually active men (unless vasectomised), partners of sexually active women, to practice continuous effective contraception, adopting two effective contraceptive methods. Une of these methods must be a barrier contraception method (condom with spermicide, diaphragm or cervical cap). In this study oral contraceptive, considered as one of the two effective forms of contraception, may be used. These contraceptive methods must be used from the screening visit for the whole duration of study and for the 24 weeks following the latest dose of Ribavirin.
• For women of fertile age a negative pregnancy test on the days of vaccination.
• Elevated serum ALT, defined as higher than ULN (41 U/L for males and 33 U/L for females) and not exceeding 10x ULN.
• Written informed consent

You may not qualify if:

• Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
• Prior recipients of a recombinant simian or human adenoviral vaccine
• Serum ALT lower than ULN (41 U/L for males and 33 U/L for females) or exceeding 10x ULN
• Advanced liver fibrosis
• Clinical, biochemical, ultrasonographic, or liver biopsy (histology) evidence of cancer or portal hypertension
• Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed)
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g., Kathon
• History of clinically significant contact dermatitis
• Any history of anaphylaxis in reaction to vaccination
• Pregnancy, lactation or willingness/intention to become pregnant during the study
• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
• Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
• Current suspected or known injecting drug abuse
• In case of history of drug and/or alcool abuse, it is necessary the abuse was terminated at least two years before the enrollment.
• Seropositive for hepatitis B surface antigen (HBsAg)

Sponsors & Collaborators

• ReiThera Srl: lead
• European Commission: collaborator

Study Sites (2)

Azienda Ospedaliera Universitaria di Pisa. Ospedale di Cisanello

Pisa, 56126, Italy

Location

Azienda Ospedaliera Universitaria Pisana. Ospedale di Santa Chiara

Pisa, 56126, Italy

Location

MeSH Terms

Conditions

Hepatitis C; Hepatitis; Adenoviridae Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases; DNA Virus Infections

Study Officials

• Ferruccio Bonino, Prof.

  Azienda Ospedaliera Universitaria. Università di Pisa. Italy

  STUDY CHAIR

• Maurizia Brunetto, Dr.

  Azienda Ospedaliera Universitaria. Università di Pisa. Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2012
• First Posted: October 5, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: February 1, 2013
• Last Updated: August 29, 2013

Record last verified: 2013-08

Locations

IT (2)