Skip to main content
OpenTrials
Completed

NCT Number: NCT04736147

A Study of JNJ-64300535 in Healthy Participants

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Belgium NV

Edegem, 2650, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-64300535

Biological

JNJ-64300535 injection will be administered intramuscularly.

Primary outcomes

  1. Percentage of Participants Responding Against Hepatitis B Virus (HBV) Core or Polymerase (Pol) Vaccine Antigens

    Time frame: Up to Day 67

    Percentage of participants responding against HBV Core or Pol vaccine antigens will be reported.

Secondary outcomes

  1. Number of Participants With Solicited Local Adverse Events (AEs)

    Time frame: 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.

  2. Number of Participants With Solicited Systematic Adverse Events

    Time frame: 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.

  3. Number of Participants With Serious Adverse Events (SAEs)

    Time frame: 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.

  4. Number of Participants With Unsolicited Adverse Events

    Time frame: 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.

  5. Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

    Time frame: 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.

  6. Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)

    Time frame: Up to Day 113

    Number of participants with clinically significant abnormalities in ECG will be reported.

  7. Number of Participants With Clinically Significant Abnormalities in Vital Signs

    Time frame: 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.

  8. Number of Participants With Clinically Significant Abnormalities in Physical Examination

    Time frame: 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.

  9. Percentage of Participants With a Positive T-cell Response Against HBV Core or Pol Vaccine Antigens

    Time frame: Up to Day 225

    Percentage of participants with a positive T-cell response against HBV Core or Pol vaccine antigens will be reported.

  10. Breadth of the T-cell Responses Against HBV Core or Pol Vaccine Antigens

    Time frame: Up to Day 225

    Breadth of the T-cell responses against HBV Core or Pol vaccine antigens will be reported.

  11. Magnitude of the T-cell Responses Against HBV Core or Pol Vaccine Antigens

    Time frame: Up to Day 225

    Magnitude of the T-cell responses against HBV Core or Pol vaccine antigens will be reported

  12. 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

    Time frame: 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.

  13. Frequency of Intramuscular TriGrid Delivery System version 2.0 (TDS-IM v2.0) Device Faulty Conditions

    Time frame: Up to Day 57

    Frequency of device fault conditions observed during administration of study treatment with TDS-IM v2.0 device will be reported.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 3, 2021
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.