Study of an siRNA injection, DNA vaccine & NUC for people with hep B
Research type
Research Study
Full title
A Phase 1b, Open-label, Single-arm, Multicentre Study to Assess Efficacy, Safety, and Tolerability of Treatment With JNJ-73763989, JNJ-64300535, and Nucleos(t)ide Analogs in Virologically Suppressed, HBeAg-negative Participants With Chronic Hepatitis B Virus Infection - the OSPREY study
IRAS ID
301303
Contact name
David Wright
Contact email
Sponsor organisation
Janssen-Cilag International NV
Eudract number
2020-005584-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 3 days
Research summary
Research Summary
The purpose of this study is to look at the effectiveness and safety of the study drugs JNJ-73763989 (‘JNJ-3989’ for short) and JNJ-64300535 vaccine (‘JNJ-0535’ for short) in people with chronic hepatitis B (‘HBV’). Each study participant will also receive a nucleos(t)ide analogue (‘NUC’) - a medicine approved in the UK for treating HBV. The combination of JNJ-3989 + NUC has the potential to lower the level of substances in the blood produced by the virus, and stop the virus from making copies of itself. This could help to restore a person’s immune response against the virus. By then adding JNJ-0535, a person’s immune response may be boosted further.
JNJ-0535 vaccine is given in clinic using a special medical device called TriGrid Delivery System version 2.0 (TDS-IM v2.0). This sends an electrical pulse into the muscle and makes tiny temporary holes or ‘pores’ in the outer layer of the cells. JNJ-0535 vaccine can then pass through the pores into the cells. The device may cause a little discomfort or pain, but this usually lasts just a few seconds.
JNJ-3989 is given in clinic as an injection. The NUC is a tablet which is taken once a day.
The study comprises a 4-week screening period, Treatment Periods 1, 2 and 3 each lasting 12 weeks and 48 weeks of follow-up. At study visits, a participant will have procedures such as blood and urine tests, physical examinations, fine needle aspiration, ECGs, fibroscans and ultrasounds. The results from these will help to see what’s happening in the blood and the liver; how the immune system is responding to treatment, and help to determine if the combination of JNJ-3989 + JNJ-0535 (given with the TDS-IM v2.0 device) + NUC is effective and safe in treating HBV.Summary of Results
N/A This is a phase 1 trial in adults.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0185
Date of REC Opinion
22 Sep 2021
REC opinion
Further Information Favourable Opinion