Phase 2
N=10
Autologous Dendritic Cell Vaccine for Treatment of Patients With Chronic HCV-Infection
Hepatitis C, Chronic · Liver Diseases · Hepatitis · Virus Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03119025 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Number of Participants With Severe Adverse Reactions and/or With Abnormal Clinical Laboratory Values That Are Related to Treatment — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous DC-vaccines (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Russian Academy of Medical Sciences
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Severe Adverse Reactions and/or With Abnormal Clinical Laboratory Values That Are Related to Treatment |
— | — |
| SECONDARY Number of Participants With Virological Response According to HCV RNA Viral Load |
4 | — |
| SECONDARY Number of Participants Who Have Developed or Increased Anti-Viral Immune Response According to T-cell Proliferation |
9 | — |
| SECONDARY Number of Participants Who Have Developed or Increased Anti-Viral Immune Response According to IFN-γ Production |
9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 65 Years (Adult)
- Chronic hepatitis C (genotype 1b)
- HCV-positive patients
- Plasma HCV RNA level ≥ 10 000 IU/ml
- Liver fibrosis (METAVIR Score 0-III)
- Patients must be able to tolerate all study procedures
- Patients must be willing to voluntarily give written Informed Consent to participate in the study before any procedures are performed
- Patients must be willing to be available for all baseline, treatment and follow-up examinations required by protocol
Exclusion Criteria
- Co-infection with hepatitis B, A, D, E, cytomegalovirus or Epstein-Barr virus
- Liver cirrhosis (METAVIR Score IV)
- The high degree of hepatitis activity (ALT and/or AST ≥ 10 ULN)
- Received any vaccine within a month prior to study entry
- A history of diabetes
- Psychiatric disorders
- Renal dysfunctions
- Hemodynamic or respiratory instability
- HIV or uncontrolled bacterial, fungal, or viral infections
- Autoimmune diseases
- Pregnancy
- Malignancy
- Participation in other clinical trials
Data sourced from ClinicalTrials.gov (NCT03119025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.