A Study of JNJ-64300535 in Healthy Participants

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736147
• Other study ID #: CR108950
• Secondary ID: 2020-005277-2764
• Status: Completed
• Phase: Phase 1
• Start date: February 3, 2021
• Est. completion date: December 7, 2021

Study information

• Verified date: December 2021
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 7, 2021
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• JNJ-64300535
JNJ-64300535 injection will be administered intramuscularly.

Locations

Country	Name	City	State
Belgium	SGS Belgium NV	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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