Clinical trial NCT04736147: A Study of JNJ-64300535 in Healthy Participants
Official title: A Phase 1 Open-label Study to Assess the Immunogenicity, Safety, and Reactogenicity of JNJ-64300535, a DNA Vaccine Administered by Electroporation-mediated Intramuscular Injection, in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Responding Against Hepatitis B Virus (HBV) Core or Polymerase (Pol) Vaccine Antigens
timeFrame: Up to Day 67
Secondary outcomes:
measure: Number of Participants With Solicited Local Adverse Events (AEs)
timeFrame: Up to Day 64
measure: Number of Participants With Solicited Systematic Adverse Events
timeFrame: Up to Day 64
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Up to Day 225
measure: Number of Participants With Unsolicited Adverse Events
timeFrame: Up to Day 225
measure: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
timeFrame: Up to Day 225
measure: Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
timeFrame: Up to Day 113
measure: Number of Participants With Clinically Significant Abnormalities in Vital Signs
timeFrame: Up to Day 225
measure: Number of Participants With Clinically Significant Abnormalities in Physical Examination
timeFrame: Up to Day 225
measure: Percentage of Participants With a Positive T-cell Response Against HBV Core or Pol Vaccine Antigens
timeFrame: Up to Day 225
measure: Breadth of the T-cell Responses Against HBV Core or Pol Vaccine Antigens
timeFrame: Up to Day 225
measure: Magnitude of the T-cell Responses Against HBV Core or Pol Vaccine Antigens
timeFrame: Up to Day 225
measure: Number of Cytokines of Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) T-cell Responses Against HBV Core or Pol Vaccine Antigens
timeFrame: Up to Day 225
measure: Frequency of Intramuscular TriGrid Delivery System version 2.0 (TDS-IM v2.0) Device Faulty Conditions
timeFrame: Up to Day 57
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: SGS Belgium NV
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: