A Study of JNJ-64300535 in Healthy Participants

NCT ID: NCT04736147

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-03

Study Completion Date

2021-12-07

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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JNJ-64300535

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

Group Type EXPERIMENTAL

JNJ-64300535

Intervention Type BIOLOGICAL

JNJ-64300535 injection will be administered intramuscularly.

Interventions

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JNJ-64300535

JNJ-64300535 injection will be administered intramuscularly.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Janssen Research & Development, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

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SGS Belgium NV

Edegem, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2020-005277-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

64300535HPB1003

Identifier Type: OTHER

Identifier Source: secondary_id

CR108950

Identifier Type: -

Identifier Source: org_study_id