A study to evaluate JNJ-64300535 DNA vaccine in chronic Hepatitis B
Research type
Research Study
Full title
A first-in-human, double-blind, randomized, placebo-controlled, Phase 1 study to evaluate the safety, tolerability, reactogenicity, and immunogenicity of JNJ-64300535, a DNA vaccine, administered by electroporation-mediated intramuscular injection, in participants with chronic hepatitis B who are on stable nucleos(t)ide therapy and virologically suppressed.
IRAS ID
228730
Contact name
Patrick Kennedy
Contact email
Sponsor organisation
Janssen Sciences Ireland UC, Little Island, CO. Cork Ireland
Eudract number
2017-000147-41
Clinicaltrials.gov Identifier
133714358, 1.0, EDMS-ERI-
Duration of Study in the UK
1 years, 11 months, 21 days
Research summary
Research Summary:
A study to evaluate the safety and tolerability of escalating doses of a therapeutic DNA vaccine given intra-muscularly by electroporation (an intense electrical pulse believed to deliver higher amounts of the vaccine into the cells)to participants with chronic hepatitis B who are on stable nucleos(t)ide therapy and virologically suppressed.Lay Summary of Results:
Study results will not be registered (this is a Phase I study) and a Plain Language Summary of the results will not be created (the study was filed under EU CTD). However, as soon as study results are published (at conferences and/or in Scientific Journals), participants can obtain information on study results (anonymous data) via their study doctor or clinical team.
Participants will be enrolled in 1 of 3 treatment panels (A, B, or C) and will receive 3 injections of JNJ-64300535 or placebo at Day 1, Week 4, and Week 12 using an electroporation delivery device (TDS-IM v2.0).As a safety precaution, the first 2 participants in each treatment panel will be a sentinel group in which 1 participant will be randomly allocated to placebo and 1 to active vaccine (1:1). Following review of the safety data for the sentinel participants, the remaining participants will be dosed and evaluated.
• Panel A: 8 participants(6/2 JNJ-64300535/placebo) - an initial dose of study vaccine (0.125 mg/plasmid).
• Panel B: 8 participants(6/2 JNJ-64300535/placebo) - mid dose (0.5 mg/plasmid) of study vaccine.
• Panel C: 15 participants(12/3 JNJ-64300535/placebo) - maximal feasible dose (MFD)dose (3 mg/plasmid).The dose for Panel B and/or C can be adjusted downward based on safety data emerging from Panel A and/or B but will not exceed the MFD of 3mg/plasmid (6mg total).
Participants will stay in the clinic for at least 2 hours following each vaccination and be monitored for development of AEs and injection site pain. Sentinel participants will stay in the clinic for 4 hours after the first vaccination.
Other safety evaluations will include clinical laboratory tests, physical examination, vital signs, electrocardiograms, urinalysis and pregnancy tests.
The effect of the vaccine will be assessed by comparing pre and post vaccination Hepatitis B and liver function test results to determine the immune response to the virus and to monitor the course of the disease.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0052
Date of REC Opinion
7 Mar 2018
REC opinion
Further Information Favourable Opinion