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

Phase 2TerminatedNCT02309086

Clinica Universidad de Navarra, Universidad de Navarra5 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C, Chronic

Interventions

Autologous dendritic cells transduced with Ad encoding NS3BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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.

Time frame: 6 months

Secondary Outcomes

Efficacy on viral load and immune response

Time frame: 6 months

Data from ClinicalTrials.gov

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