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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

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

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02309086
Enrollment
5
Registered
2014-12-05
Start date
2011-05-31
Completion date
2014-05-31
Last updated
2017-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

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

Interventions

BIOLOGICALAutologous dendritic cells transduced with Ad encoding NS3

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

Sponsors

Centro de Investigación Médica Aplicada (CIMA)
CollaboratorUNKNOWN
Clinica Universidad de Navarra, Universidad de Navarra
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 monthsSafety 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

MeasureTime frame
Efficacy on viral load and immune response6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026