A Study of JNJ-64300535 in Healthy Participants

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: JNJ-64300535

Study type: Interventional

Funder types: Industry

Identifiers

NCT04736147

2020-005277-27 (EudraCT Number)

64300535HPB1003 (Other Identifier)

CR108950

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

JNJ-64300535

Experimental group

Description:

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

Treatment:

Biological: JNJ-64300535