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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

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Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 Aug 2022

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At a glance

  • Drugs JNJ-64300535 (Primary) ; Nucleoside reverse transcriptase inhibitors
  • Indications Hepatitis B
  • Focus Adverse reactions; First in man
  • Sponsors Janssen Sciences Ireland UC

Most Recent Events

  • 26 Jun 2022 Results from two clinical studies (64300535HPB1003 and 64300535HPB1001) reporting T cell responses and ELISpot responses over baseline to core and/or polymerase in Chronic Hepatitis B patients presented at The International Liver Congress 2022
  • 13 Apr 2021 Status changed from active, no longer recruiting to completed.
  • 12 May 2020 Planned End Date changed from 1 Mar 2021 to 23 Mar 2021.

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