A Study of JNJ-64300535 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: JNJ-64300535

• Registration Number: NCT04736147
• Lead Sponsor: Janssen Research & Development, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-29
• Study First Submitted QC: 2021-01-29
• Study Start: 2021-02-03
• Study First Posted: 2021-02-03
• Status Verified: 2021-12
• Primary Completion: 2021-12-07
• Study Completion: 2021-12-07
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2021-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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 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.
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 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 Clinically Significant Abnormalities in Electrocardiogram (ECG)	Up to Day 113	Number of participants with clinically significant abnormalities in ECG will be reported.
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.
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.
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.
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.

Trial Locations

Locations (1)

SGS Belgium NV; 🇧🇪 Edegem, Belgium