Trial Outcomes & Findings for Autologous Dendritic Cell Vaccine for Treatment of Patients With Chronic HCV-Infection (NCT NCT03119025)

NCT ID: NCT03119025

Last Updated: 2019-05-10

Results Overview

Frequency of severe adverse reactions will be evaluated from enrollment and up to 13 months. Liver safety by blood analysis (ALT, AST, GGT, Total and conjugated bilirubin, platelets, ESR, etc) and Ultrasound will be assessed from enrollment and up to 13 months (= baseline, 2, 7 and 13 months after 1-st vaccination).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

From enrollment and up to 13 months

Results posted on

2019-05-10

Participant Flow

The recruitment, assessment and treatment of patients were conducted from May 2015 to November 2016 in a Clinic of Immunopathology affiliated with Institute of Fundamental and Clinical Immunology, that currently holds a license for cell technology application.

Participant milestones

Participant milestones
Measure	Autologous DC-vaccines Ten patients with chronic hepatitis C (genotype 1) were received the initiating and maintaining courses of autologous monocyte-derived dendritic cells, generated in the presence of IFN-α/GM-CSF and loaded with recombinant HCV Core (1-120) and NS3 (1192-1457) proteins. Autologous DC-vaccines: Patients were vaccinated via intracutaneous injection of autologous DCs (5×106) combined with adjuvant subcutaneous injection of recombinant hIL-2 (250 000 IU). Initiating course: one vaccination per week, during 1 month. Maintaining course: one vaccination per month, during 6 month. Patients were monitored at baseline (before the first vaccination) and in a 2 months (after completing of initiating course), 7 months (after completing of maintaining course) and 13 months (in a 6 months post-vaccination follow-up).
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Autologous DC-vaccines n=10 Participants Ten patients with chronic hepatitis C (genotype 1) were received the initiating and maintaining courses of autologous monocyte-derived dendritic cells, generated in the presence of IFN-α/GM-CSF and loaded with recombinant HCV Core (1-120) and NS3 (1192-1457) proteins. Autologous DC-vaccines: Patients were vaccinated via intracutaneous injection of autologous DCs (5×106) combined with adjuvant subcutaneous injection of recombinant hIL-2 (250 000 IU). Initiating course: one vaccination per week, during 1 month. Maintaining course: one vaccination per month, during 6 month. Patients were monitored at baseline (before the first vaccination) and in a 2 months (after completing of initiating course), 7 months (after completing of maintaining course) and 13 months (in a 6 months post-vaccination follow-up).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	35.5 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Russia	10 participants n=5 Participants
Patients with chronic hepatitis C (genotype 1b)	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: From enrollment and up to 13 months

Population: Most patients had minimal hepatitis activity as evidenced by normal or slightly increased liver transaminase levels. Serum HCV RNA levels ranged from 1.3 × 104 IU/mL to 1.8 × 106 IU/mL. Fibrosis stage ranged from F0 to F3 according to Metavir system scores.

Outcome measures

Outcome measures
Measure	Autologous DC-vaccines n=10 Participants Ten patients with chronic hepatitis C (genotype 1) were received the initiating and maintaining courses of autologous of autologous monocyte-derived dendritic cells, generated in the presence of IFN-α/GM-CSF and loaded with recombinant HCV Core (1-120) and NS3 (1192-1457) proteins. Autologous DC-vaccines: Patients were vaccinated via subcutaneous injection of autologous DCs (5×106) combined with adjuvant subcutaneous injection of recombinant hIL-2 (250 000 IU). Initiating course: one vaccination per week, during 1 month. Maintaining course: one vaccination per month, during 6 month. Patients were monitored at baseline (before the first vaccination) and in a 2 months (after completing of initiating course), 7 months (after completing of maintaining course) and 13 months (in a 6 months post-vaccination follow-up).
Number of Participants With Severe Adverse Reactions and/or With Abnormal Clinical Laboratory Values That Are Related to Treatment	0 Participants

SECONDARY outcome

Timeframe: Baseline, 2, 7 and 13 months after 1-st vaccination

Virological response in patients receiving DC-vaccinations is defined as change from baseline in HCV RNA viral load by at least 1 log at 2, 7 and 13 month after 1-st vaccination. Plasma level of HCV RNA will be measured by Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR)

Outcome measures

Outcome measures
Measure	Autologous DC-vaccines n=10 Participants Ten patients with chronic hepatitis C (genotype 1) were received the initiating and maintaining courses of autologous of autologous monocyte-derived dendritic cells, generated in the presence of IFN-α/GM-CSF and loaded with recombinant HCV Core (1-120) and NS3 (1192-1457) proteins. Autologous DC-vaccines: Patients were vaccinated via subcutaneous injection of autologous DCs (5×106) combined with adjuvant subcutaneous injection of recombinant hIL-2 (250 000 IU). Initiating course: one vaccination per week, during 1 month. Maintaining course: one vaccination per month, during 6 month. Patients were monitored at baseline (before the first vaccination) and in a 2 months (after completing of initiating course), 7 months (after completing of maintaining course) and 13 months (in a 6 months post-vaccination follow-up).
Number of Participants With Virological Response According to HCV RNA Viral Load	4 Participants

SECONDARY outcome

Timeframe: Baseline, 2, 7, and 13 months after 1-st vaccination

Change from baseline in T-cell proliferative response to HCV Core and NS3 proteins at 2, 7 and 13 month after 1-st vaccination. T-cell proliferation will be evaluated using radiometry based on 3H-thymidine incorporation

Outcome measures

Outcome measures
Measure	Autologous DC-vaccines n=10 Participants Ten patients with chronic hepatitis C (genotype 1) were received the initiating and maintaining courses of autologous of autologous monocyte-derived dendritic cells, generated in the presence of IFN-α/GM-CSF and loaded with recombinant HCV Core (1-120) and NS3 (1192-1457) proteins. Autologous DC-vaccines: Patients were vaccinated via subcutaneous injection of autologous DCs (5×106) combined with adjuvant subcutaneous injection of recombinant hIL-2 (250 000 IU). Initiating course: one vaccination per week, during 1 month. Maintaining course: one vaccination per month, during 6 month. Patients were monitored at baseline (before the first vaccination) and in a 2 months (after completing of initiating course), 7 months (after completing of maintaining course) and 13 months (in a 6 months post-vaccination follow-up).
Number of Participants Who Have Developed or Increased Anti-Viral Immune Response According to T-cell Proliferation	9 Participants

SECONDARY outcome

Timeframe: Baseline, 2, 7 and 13 months after 1-st vaccination

Change from baseline in T-cell IFN-γ-producing response to HCV Core and NS3 proteins at 2, 7 and 13 month after 1-st vaccination. Production of IFN-γ will be measured by ELISA kit

Outcome measures

Outcome measures
Measure	Autologous DC-vaccines n=10 Participants Ten patients with chronic hepatitis C (genotype 1) were received the initiating and maintaining courses of autologous of autologous monocyte-derived dendritic cells, generated in the presence of IFN-α/GM-CSF and loaded with recombinant HCV Core (1-120) and NS3 (1192-1457) proteins. Autologous DC-vaccines: Patients were vaccinated via subcutaneous injection of autologous DCs (5×106) combined with adjuvant subcutaneous injection of recombinant hIL-2 (250 000 IU). Initiating course: one vaccination per week, during 1 month. Maintaining course: one vaccination per month, during 6 month. Patients were monitored at baseline (before the first vaccination) and in a 2 months (after completing of initiating course), 7 months (after completing of maintaining course) and 13 months (in a 6 months post-vaccination follow-up).
Number of Participants Who Have Developed or Increased Anti-Viral Immune Response According to IFN-γ Production	9 Participants

Adverse Events

Autologous DC-vaccines

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Alexander A Ostanin, MD, PhD Study Principal Investigator

Institute of Fundamental and Clinical Immunology

Phone: 383-236-03-29

Email: [email protected]; [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place