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

NCT01701336 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2013-08-29

No results posted yet for this study

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

Interventions

BIOLOGICAL

Ad6NSmut, MVA-NSmut

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

Sponsors & Collaborators

Principal Investigators

  • Ferruccio Bonino, Prof. · Azienda Ospedaliera Universitaria. Università di Pisa. Italy

  • Maurizia Brunetto, Dr. · Azienda Ospedaliera Universitaria. Università di Pisa. Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-10-31
Completion
2013-02-28

Countries

  • Italy

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701336 on ClinicalTrials.gov