drugset / Trial / NCT03119025

Autologous Dendritic Cell Vaccine for Treatment of Patients With Chronic HCV-Infection

NCT03119025

Phase 1/2 Completed 10 enrolled Russian Academy of Medical Sciences
NaSingle-groupOpen-labelTreatment

Summary

Clearance of HCV infection requires early and multi-specific HLA class I restricted CD8+ T cell and class II restricted CD4+ T cell responses to both structural (Core) and non-structural HCV proteins (NS3, NS4A, NS5A, NS5B). Dendritic cells (DCs) are professional antigen-presenting cells that link innate and adaptive immune responses, and play a major role in priming, initiating, and sustaining strong anti-HCV T cell immune responses. The general objective of this study is to evaluate safety, feasibility and clinical efficacy of therapeutic vaccination in genotype 1 HCV patients using autologous DCs pulsed with recombinant HCV-antigens (Core and NS3). Expected effects: DC vaccination induces Core/NS3-specific immune response and reduces viral load in patients with chronic HCV-infection.

Timeline

Start
2015-05
Primary completion
2018-02
Completion
2018-04

Publications

  • Background Oleynik EA, Leplina OY, Tyrinova TV, Tikhonova MA, Pyrinova GB, Ostanin AA, Starostina NM, Chernykh ER. The influence of recombinant HCV proteins Core and NS3 on maturation and functions of dendritic cells generated in vitro with interferon-alpha. Immunology 37 (5): 239-245, 2016. (in Russian) DOI: 10.18821/0206-4952-2016-37-5-239-245

Drugs

EvaluationDrugModalityDoseRoute
Subject Autologous DC-vaccines Cell therapy 5e+06 cells Other
Background CELMOLEUKIN Protein / enzyme biologic 250000 iu Subcutaneous