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Phase I-II Vaccination of Autologous Dendritic Cells Transduced With Adenoviral Vector Encoding NS3 in Hepatitis C Encoding NS3 in Hepatitis C

NCT ID: NCT02309086

Last Updated: 2017-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-05-31

Brief Summary

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Dendritic cells (DC) play a central role in the activation of T-cell responses and have shown to be very immunogenic in preclinical in vivo and in vitro assays. The aims of this study is to assess the efficacy of therapeutic vaccination pilot clinical trial in Genotype 1 HCV patients using autologous DC transduced with a recombinant adenovirus encoding NS3

Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Autologous dendritic cells transduced with Ad encoding NS3

Group Type EXPERIMENTAL

Autologous dendritic cells transduced with Ad encoding NS3

Intervention Type BIOLOGICAL

Patients will receive 3 different dosis of the vaccine via subcutaneous injection

Interventions

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Autologous dendritic cells transduced with Ad encoding NS3

Patients will receive 3 different dosis of the vaccine via subcutaneous injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Chronic hepatitis C (genotype 1b) that had previously failed Interferon/Ribavirin-based treatment

Exclusion Criteria

Liver cirrhosis HBV-coinfection Bilirubin \>1.5 times ULN or ALT \>7 ULN Hepatocellular carcinoma Immunodeficiency
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro de Investigación Médica Aplicada (CIMA)

UNKNOWN

Sponsor Role collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CD-AdNS3

Identifier Type: -

Identifier Source: org_study_id