Healthy
Conditions
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.
Interventions
BIOLOGICALJNJ-64300535
JNJ-64300535 injection will be administered intramuscularly.
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Responding Against Hepatitis B Virus (HBV) Core or Polymerase (Pol) Vaccine Antigens | Up to Day 67 | Percentage of participants responding against HBV Core or Pol vaccine antigens will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Systematic Adverse Events | Up to Day 64 | 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. |
| Number of Participants With Serious Adverse Events (SAEs) | Up to Day 225 | 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. |
| Number of Participants With Unsolicited Adverse Events | Up to Day 225 | 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. |
| Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters | Up to Day 225 | Number of participants with clinically significant abnormalities in laboratory parameters such as (hematology, blood biochemistry, blood coagulation and urinalysis) will be reported. |
| Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG) | Up to Day 113 | Number of participants with clinically significant abnormalities in ECG will be reported. |
| Number of Participants With Clinically Significant Abnormalities in Vital Signs | Up to Day 225 | Number of participants with clinically significant abnormalities in vital signs (including body temperature, pulse/heart rate, systolic and diastolic blood pressure) will be reported. |
| Number of Participants With Solicited Local Adverse Events (AEs) | Up to Day 64 | 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. |
| Percentage of Participants With a Positive T-cell Response Against HBV Core or Pol Vaccine Antigens | Up to Day 225 | Percentage of participants with a positive T-cell response against HBV Core or Pol vaccine antigens will be reported. |
| Breadth of the T-cell Responses Against HBV Core or Pol Vaccine Antigens | Up to Day 225 | Breadth of the T-cell responses against HBV Core or Pol vaccine antigens will be reported. |
| Magnitude of the T-cell Responses Against HBV Core or Pol Vaccine Antigens | Up to Day 225 | Magnitude of the T-cell responses against HBV Core or Pol vaccine antigens will be reported |
| 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 | Up to Day 225 | Number of cytokines of both CD4 and CD8 T-cell responses against HBV Core or Pol vaccine antigens will be reported. |
| Frequency of Intramuscular TriGrid Delivery System version 2.0 (TDS-IM v2.0) Device Faulty Conditions | Up to Day 57 | Frequency of device fault conditions observed during administration of study treatment with TDS-IM v2.0 device will be reported. |
| Number of Participants With Clinically Significant Abnormalities in Physical Examination | Up to Day 225 | Number of participants with clinically significant abnormalities in physical examination (including height, body weight, skin examination, and other body systems) will be reported. |
Countries
Belgium
Outcome results
None listed