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Study of a Novel Therapeutic Vaccine for Hepatitis C Virus

NCT01094873 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2015-04-23

No results posted yet for this study

Summary

HCV002TV is a Phase I study to ascertain the safety and immunogenicity of a novel vaccine against Hepatitis C virus (HCV) in chronically infected patients. The vaccine is based on the sequential delivery, by intramuscular route, of two different adenoviral vectors, of chimpanzee and human origin respectively, bearing the same genetic information for HCV antigens (NS region).

The two recombinant vaccine vectors, called AdCh3NSmut and Ad6NSmut, are weakened and unable to multiply within the body; they are designed to induce an immune response against HCV proteins. AdCh3NSmut and Ad6NSmut are being used in the ongoing HCV001 study in healthy volunteers with very good safety and immunogenicity results.

HCV002TV is a dose-escalation study; the AdCh3NSmut is administered as priming vaccination and Ad6NSmut as boosting vaccination.

The trial includes:

* Arm A, in which vaccinated patients are into Interferon-ribavirin therapy (the gold standard therapy for hepatitis C);
* Arm B, in which vaccinated patients are not into therapy.

Conditions

  • Hepatitis C

Interventions

BIOLOGICAL

AdCh3NSmut

Genetic vaccines against Hepatitis C virus infection

BIOLOGICAL

Ad6NSmut

Genetic vaccine against Hepatitis C virus infection

Sponsors & Collaborators

  • University of Oxford

    collaborator OTHER

  • ReiThera Srl

    lead INDUSTRY

Principal Investigators

  • Eleanor Barnes, MD · University of Oxford, UK

  • David Mutimer, Dr. · University of Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United Kingdom

Study Locations

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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 NCT01094873 on ClinicalTrials.gov