HealthyPhase 1NCT04736147
A Study of JNJ-64300535 in Healthy Participants
A Phase 1 study testing JNJ-64300535 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-64300535
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 3 Feb 2021to 7 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- JNJ-64300535
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-64300535Biological
JNJ-64300535 injection will be administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-64300535 | Experimental | Participants will receive an electroporation-mediated intramuscular (IM) injection of JNJ-64300535 vaccine. Receives: Biological: JNJ-64300535 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 67
Secondary outcomes (13)
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.
Measured: Up to Day 64
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.
Measured: Up to Day 64
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.
Measured: Up to Day 225
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.
Measured: Up to Day 225
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.
Measured: Up to Day 225
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
Number of participants with clinically significant abnormalities in ECG will be reported.
Measured: Up to Day 113
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.
Measured: Up to Day 225
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.
Measured: Up to Day 225
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.
Measured: Up to Day 225
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.
Measured: Up to Day 225
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
Measured: Up to Day 225
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.
Measured: Up to Day 225
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.
Measured: Up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start3 Feb 2021
- Primary completion7 Dec 2021
- Study completion7 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736147
- Sponsor's protocol ID
- CR108950
- Other IDs
- 2020-005277-27, 64300535HPB1003
- Status last verified
- Dec 2021
- First submitted
- 29 Jan 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Publications
Verheijden S, Conceicao-Neto N, Bourgeois S, Vandamme C, Troyer E, Kanoulas E, Maeyer D, Crabbe M, Makariadou E, Slaets L, Fevery B, Remoortere PV, Biermer M, Kennedy PTF, De Creus A. Safety, immunogenicity, and baseline immune correlates of vaccine JNJ-0535 in participants with or without CHB. NPJ Vaccines. 2026 Feb 5;11(1):45. doi: 10.1038/s41541-025-01364-x.
PubMed 41644953
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04736147
- Acronym / sponsor ID
- CR108950
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 7 Dec 2021 (actual)
- Study completion
- 7 Dec 2021 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JNJ-64300535 | Experimental | Biological: JNJ-64300535Participants will receive an electroporation-mediated intramuscular (IM) injection of JNJ-64300535 vaccine. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-64300535JNJ-64300535 injection will be administered intramuscularly. | Biological | JNJ-64300535 |
Primary outcome
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.
13 secondary outcomes
Number of Participants With Solicited Local Adverse Events (AEs)
Time frame: Up to Day 64
Number of Participants With Solicited Systematic Adverse Events
Time frame: Up to Day 64
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to Day 225
Number of Participants With Unsolicited Adverse Events
Time frame: Up to Day 225
Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Time frame: Up to Day 225
Number of Participants With Clinically Significant Abnormalities in Electrocardiogram (ECG)
Time frame: Up to Day 113
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Time frame: Up to Day 225
Number of Participants With Clinically Significant Abnormalities in Physical Examination
Time frame: Up to Day 225
Percentage of Participants With a Positive T-cell Response 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
Time frame: Up to Day 225
Magnitude of the T-cell Responses Against HBV Core or Pol Vaccine Antigens
Time frame: Up to Day 225
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
Frequency of Intramuscular TriGrid Delivery System version 2.0 (TDS-IM v2.0) Device Faulty Conditions
Time frame: Up to Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Derived from this study: PubMed 41644953Verheijden S, Conceicao-Neto N, Bourgeois S, Vandamme C, Troyer E, Kanoulas E, Maeyer D, Crabbe M, Makariadou E, Slaets L, Fevery B, Remoortere PV, Biermer M, Kennedy PTF, De Creus A. Safety, immunogenicity, and baseline immune correlates of vaccine JNJ-0535 in participants with or without CHB. NPJ Vaccines. 2026 Feb 5;11(1):45. doi: 10.1038/s41541-025-01364-x.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-64300535 in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Responding Against Hepatitis B Virus (HBV) Core or Polymerase (Pol) Vaccine Antigens (time frame: Up to Day 67). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04736147, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.