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

Summary

The purpose of this study is to evaluate the safety, tolerability, and reactogenicity of escalating doses of JNJ-64300535 delivered via electroporation-mediated intramuscular injection in nucleos(t)ide analogs (NA)-treated chronic hepatitis B (CHB) participants.

Timeline

Start

2018-04-18

Primary completion

2021-03-23

Completion

2021-03-23

Publications

• Verheijden S, Conceicao-Neto N, Bourgeois S, Vandamme C, Troyer E, Kanoulas E, Maeyer D, Crabbe M, Makariadou E, Slaets L, Fevery B, Remoortere PV, Biermer M, Kennedy PTF, De Creus A. Safety, immunogenicity, and baseline immune correlates of vaccine JNJ-0535 in participants with or without CHB. NPJ Vaccines. 2026 Feb 5;11(1):45. doi: 10.1038/s41541-025-01364-x.

Drugs

Indications