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

October 23, 2017 updated by: Clinica Universidad de Navarra, Universidad de Navarra

Phase I-II Vaccination Clinical Trial in Patients With Chronic Hepatitis C by Administration of Autologous Dendritic Cells Transduced With an Adenoviral Vector Encoding NS3 Protein

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm
Autologous dendritic cells transduced with Ad encoding NS3
Biological: Autologous dendritic cells transduced with Ad encoding NS3
Patients will receive 3 different dosis of the vaccine via subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound.
Time Frame: 6 months
Safety assessment will be determined by the evaluation of the number of participants with the type adverse events. Liver safety will be assessed by blood analysis and Ultrasound.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy on viral load and immune response
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Collaborators

Centro de Investigación Médica Aplicada (CIMA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 23, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD-AdNS3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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