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

University of Navarra

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Hepatitis C, Chronic

Treatments: Biological: Autologous dendritic cells transduced with Ad encoding NS3

Study type: Interventional

Funder types: Other

Identifiers

NCT02309086

CD-AdNS3

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Single arm

Experimental group

Description:

Autologous dendritic cells transduced with Ad encoding NS3

Treatment:

Biological: Autologous dendritic cells transduced with Ad encoding NS3