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

Phase 1

Terminated

• Conditions: Hepatitis C, Chronic
• Interventions: Biological: Autologous dendritic cells transduced with Ad encoding NS3

• Registration Number: NCT02309086
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2013-05
• Study Completion: 2014-05
• Study First Submitted: 2014-11-18
• Study First Submitted QC: 2014-12-04
• Study First Posted: 2014-12-05
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-23
• Last Update Posted: 2017-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Autologous dendritic cells transduced with Ad encoding NS3	Autologous dendritic cells transduced with Ad encoding NS3

Primary Outcome Measures

Name	Time	Method
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.	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy on viral load and immune response	6 months