A Study of JNJ-64300535 in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Biological: JNJ-64300535


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-64300535<br>Participants will receive an electroporation-mediated intramuscular (IM) injection of JNJ-64300535 vaccine. | Biological: JNJ-64300535<br>* JNJ-64300535 injection will be administered intramuscularly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Solicited Local Adverse Events (AEs) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Solicited local AEs are pre-defined local (at the injection site) AEs for which participants will be specifically questioned and which will be noted by participants in their diary for 7 days post first vaccination. Solicited local AEs are: injection site pain/tenderness, erythema, induration/swelling, itching at the vaccination site. | Up to Day 64 | 
| Number of Participants With Solicited Systematic Adverse Events | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) for solicited systemic AEs. Solicited systemic events will include fever, headache, fatigue/malaise, myalgia, nausea/vomiting, arthralgia and chills. | Up to Day 64 | 
| Number of Participants With Serious Adverse Events (SAEs) | A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with SAEs will be reported. | Up to Day 225 | 
| Number of Participants With Unsolicited Adverse Events | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Unsolicited AEs are events which will be reported by the participant voluntarily or obtained by means of interviewing the participant in a non-directed manner at study visits. | Up to Day 225 | 
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Number of participants with clinically significant abnormalities in laboratory parameters such as (hematology, blood biochemistry, blood coagulation and urinalysis) will be reported. | Up to Day 225 | 
| Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | Number of participants with clinically significant abnormalities in ECG will be reported. | Up to Day 113 | 
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Number of participants with clinically significant abnormalities in vital signs (including body temperature, pulse/heart rate, systolic and diastolic blood pressure) will be reported. | Up to Day 225 | 
| Number of Participants With Clinically Significant Abnormalities in Physical Examination | Number of participants with clinically significant abnormalities in physical examination (including height, body weight, skin examination, and other body systems) will be reported. | Up to Day 225 | 
| Percentage of Participants With a Positive T-cell Response Against HBV Core or Pol Vaccine Antigens | Percentage of participants with a positive T-cell response against HBV Core or Pol vaccine antigens will be reported. | Up to Day 225 | 
| Breadth of the T-cell Responses Against HBV Core or Pol Vaccine Antigens | Breadth of the T-cell responses against HBV Core or Pol vaccine antigens will be reported. | Up to Day 225 | 
| Magnitude of the T-cell Responses Against HBV Core or Pol Vaccine Antigens | Magnitude of the T-cell responses against HBV Core or Pol vaccine antigens will be reported | Up to Day 225 | 
| 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 | Number of cytokines of both CD4 and CD8 T-cell responses against HBV Core or Pol vaccine antigens will be reported. | Up to Day 225 | 
| Frequency of Intramuscular TriGrid Delivery System version 2.0 (TDS-IM v2.0) Device Faulty Conditions | Frequency of device fault conditions observed during administration of study treatment with TDS-IM v2.0 device will be reported. | Up to Day 57 |