A Study of JNJ-64300535 in Healthy Participants

NCT04736147 | Completed Phase 1

• 3 other identifiers: CR1089502020-005277-2764300535HPB1003
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the cellular immunogenicity of 3 monthly electroporation-mediated intramuscular (IM) injections of JNJ-64300535 in healthy participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Responding Against Hepatitis B Virus (HBV) Core or Polymerase (Pol) Vaccine Antigens

  Percentage of participants responding against HBV Core or Pol vaccine antigens will be reported.

  Up to Day 67

Secondary Outcomes (13)

• Number of Participants With Solicited Local Adverse Events (AEs)

  Up to Day 64

• Number of Participants With Solicited Systematic Adverse Events

  Up to Day 64

• Number of Participants With Serious Adverse Events (SAEs)

  Up to Day 225

• Number of Participants With Unsolicited Adverse Events

  Up to Day 225

• Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

  Up to Day 225

Study Arms (1)

JNJ-64300535

EXPERIMENTAL

Participants will receive an electroporation-mediated intramuscular (IM) injection of JNJ-64300535 vaccine.

Biological: JNJ-64300535

Interventions

JNJ-64300535 BIOLOGICAL

JNJ-64300535 injection will be administered intramuscularly.

JNJ-64300535

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Must sign an informed consent form (ICF) indicating that he understands the purpose, procedures and potential risks and benefits of the study, and is willing to participate in the study
• Willing and able to adhere to the prohibitions and restrictions specified in this protocol
• Must be healthy as confirmed by medical history, physical examination, and vital signs performed at screening

You may not qualify if:

• Weight of less than (\<) 50 kilograms (kg) and a body mass index (BMI) \<19.0 or greater than (\>) 29.9 kilogram per meter square (kg/m\^2) at screening
• History of Human Immunodeficiency Virus (HIV) infection or a positive HIV antibody test at screening
• History of HBV infection, measured by the presence of HBsAg and/or anti-HBc antibodies
• History of seizure disorders unless seizure free for \>5 years
• Has a non-removable active electronic stimulation device

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

SGS Belgium NV

Edegem, 2650, Belgium

Location

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: February 3, 2021
• Primary Completion: December 7, 2021
• Study Completion: December 7, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)