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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dendritic cell immunotherapy in hepatitis C virus (HCV)-infected individuals.
Scientific title
Safety and efficacy of dendritic cell immunotherapy in patients with hepatitis C virus infection.
Secondary ID [1] 273296 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C virus infection. 279067 0
Condition category
Condition code
Oral and Gastrointestinal 279256 279256 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 279258 279258 0 0
Other infectious diseases

Study type
Description of intervention(s) / exposure
Dendritic cell immunotherapy to elicit HCV-specific cell mediated immunity in patients who have previously failed interferon-based therapy. The dose will vary from 1 dose unit (DU) representing 10 million, HCV-specific peptide pulsed monocyte-derived dendritic cells, to 5 DU on 1, 2 or 3 occasions at weekly intervals.
As this trial was a first in man, the dose variation was decided after consultation with the Therapeutic Goods Administration and was based on previous dendritic cell therapy cancer trials as follows:

Patient #1-1 DU by the intravenous route and 1DU by the intradermal route.

Patient #2-1DU by the intravenous route on 2 occasions, two weeks apart, accompanied by 1DU by the intradermal route on both occasions.

Patient #3-1DU followed by 2DU and 5DU at 2 weekly intervals by the intravenous route, accompanied by 1DU by the intradermal route at each time point.

Patient #4-1DU followed by 5DU at 2 weekly intervals by the intravenous route, accompanied by 1DU by the intradermal route at each time point.

Patient #5-2DU on 3 occasions, 2 weeks apart by the intravenous route, accompanied by 1DU by the intradermal route at each time point.

Patient #6-2DU on 3 occasions, 2 weeks apart by the intradermal route.
Intervention code [1] 283643 0
Treatment: Other
Comparator / control treatment
Patients will represent their own control as the viral load and immunological measures will be studied before and after intervention.
Control group

Primary outcome [1] 279878 0
Product safety, as determined by:
*Clinical examination.
*Full blood examination.
*Clinical chemistry including liver function tests.
Timepoint [1] 279878 0
Weekly during intervention and for 6 weeks after final dose.
Secondary outcome [1] 294664 0
Viral load will be assessed by reverse-transcriptase polymerase chain reaction (RT-PCR).
Timepoint [1] 294664 0
Weekly during intervention and for 6 weeks after final dose.

Key inclusion criteria
HCV RNA positive for >6 months.
Previously failed interferon-based therapy.
Infected with genotype 1.
Minimum age
18 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Evidence of liver infection with other hepatitis agents, viz. HAV, HBV.
HIV infection.
Evidence of autoimmunity.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be enrolled by the clinician who provides care on a routine basis. The trial will be discussed during a normal appointment in the liver clinic, and the patient will be provided with a patient information and consent form. The consent form must be signed in the clinic in the presence of the liver specialist.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
The trial is a dose escalation trial.
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4668 0

Funding & Sponsors
Funding source category [1] 284124 0
Government body
Name [1] 284124 0
National Institutes of Health
Address [1] 284124 0
31 Center Drive #2A03
Bethesda, MD 20892-0001
Country [1] 284124 0
United States of America
Primary sponsor type
Eric J Gowans
Burnet Institute
GPO Box 2284
Melbourne, VIC 3001
Secondary sponsor category [1] 269086 0
Name [1] 269086 0
Address [1] 269086 0
Country [1] 269086 0
Other collaborator category [1] 252320 0
Name [1] 252320 0
Alfred Hospital
Address [1] 252320 0
Commercial Road
Melbourne, VIC 3001
Country [1] 252320 0

Ethics approval
Ethics application status
Ethics committee name [1] 272083 0
AMREP (Alfred Medical Research and Education Precinct.
Ethics committee address [1] 272083 0
Commercial Road
Melbourne, VIC 3001
Ethics committee country [1] 272083 0
Date submitted for ethics approval [1] 272083 0
Approval date [1] 272083 0
Ethics approval number [1] 272083 0

Brief summary
The study will examine the possibility that dendritic cell immunotherapy might increase HCV-specific cell mediated immunity with a concomitant decrease in the viral load, or even viral clearance.
Trial website
Trial related presentations / publications
Jackson DC, Deliyannis G, Eriksson E, Dinatale I, Rizkalla M, Gowans EJ (2005). Dendritic cell immunotherapy of hepatitis C virus infection: toxicology of lipopeptide-loaded dendritic cells. Int J Peptide Res Ther 11: 223-235.
Chua B, Eriksson EM, Brown LE, Zeng W, Gowans EJ, Torresi J, Jackson DC (2008). A self-adjuvanting lipopeptide-based vaccine candidate for the treatment of hepatitis C virus infection. Vaccine 26:4866-75.
Kathryn L. Jones, Lorena E. Brown, Emily M.Y. Eriksson, Rose A. Ffrench, Philippe A. Latour, Bruce E. Loveland, Dominic M. Wall, Stuart K Roberts, David C. Jackson, Eric J. Gowans (2008). Human dendritic cells pulsed with specific lipopeptides stimulate autologous antigen-specific CD8+ T-cells without the addition of exogenous maturation factors. J Viral Hepatitis 15: 761-72.
Gowans EJ, Roberts S, Jones K, Dinatale I, Latour PA, Chua B, Eriksson EMY, Chin R, Li S, Wall DM, Sparrow RL, Moloney J, Loudovaris M, Ffrench R, Prince HM, Hart D, Zeng W, Torresi J, Brown LE, Jackson DC (2010). A phase I clinical trial of dendritic cell immunotherapy in HCV-infected individuals. J Hepatology. 53(4): 599-607.
Public notes

Principal investigator
Name 33329 0
Address 33329 0
Country 33329 0
Phone 33329 0
Fax 33329 0
Email 33329 0
Contact person for public queries
Name 16576 0
Bruce Loveland
Address 16576 0
Burnet Institute
GPO Box 2284
Melbourne, VIC 3001
Country 16576 0
Phone 16576 0
613 9282 2221
Fax 16576 0
613 9282 2111
Email 16576 0
Contact person for scientific queries
Name 7504 0
Eric J Gowans
Address 7504 0
Burnet Institute
GPO Box 2284
Melbourne. VIC 3001
Country 7504 0
Phone 7504 0
61 422 928 906
Fax 7504 0
613 9282 2111
Email 7504 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary