A Study of JNJ-64300535 in Healthy Participants

Janssen Research & Development, LLC14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

JNJ-64300535BIOLOGICAL

JNJ-64300535 injection will be administered intramuscularly.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SGS Belgium NV

Edegem, Belgium

Outcomes

Primary Outcomes

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.

Time frame: Up to Day 67

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Up to Day 225

Data from ClinicalTrials.gov

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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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Up to Day 57