NCT03463369 - A First-In-Human Study to Evaluate 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

April 18, 2018

Primary Completion Date

March 23, 2021

Study Completion Date

March 23, 2021

Conditions

Hepatitis B, Chronic

Interventions

BIOLOGICAL

JNJ-64300535

Participants will receive JNJ-64300535 vaccine by electroporation-mediated IM injection on Day 1, Week 4, and Week 12.

BIOLOGICAL

Placebo

Participants will receive 1 mL (0.9 percent \[%\] sodium chloride \[NaCl\]) of placebo solution matching to JNJ-64300535 electroporation-mediated IM injection on Day 1, Week 4, and Week 12.

DRUG

Nucleos(t)ide Analogs (NA)

Participants will receive NA as a standard of care treatment.

Trial Locations (14)

30625

MH Hannover, Hanover

45122

Universitätsklinikum Essen, UK Essen

68167

Ruprecht-Karls-U Mannheim, Mannheim

Unknown

ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg, Antwerp

Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc, Brussels

Universite Libre de Bruxelles (ULB) - Hopital Erasme, Brussels

IFI Hamburg, Hamburg

UK Leipzig, Leipzig

Universität Regensburg, Regensburg

Bart's Health - Blizard Inst. London, London

B15 2GW

Queen Elizabeth - Birmingham, Birmingham

NW3 2PF

Royal Free - London, London

SE5 9RS

King's College - London, London

E1 1BB

Pennine Acute Hospitals - Manchester, Manchester

All Listed Sponsors

lead

Janssen Sciences Ireland UC

INDUSTRY