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Hepatitis B, ChronicPhase 1NCT03463369

A First-In-Human Study to Evaluate Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(t)Ide Therapy and Virologically Suppressed

A Phase 1 study testing JNJ-64300535 and Nucleos(t)ide Analogs (NA) in people with Hepatitis B, Chronic, run by Janssen Sciences Ireland UC at 14 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the safety, tolerability, and reactogenicity of escalating doses of JNJ-64300535 delivered via electroporation-mediated intramuscular injection in nucleos(t)ide analogs (NA)-treated chronic hepatitis B (CHB) participants. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
JNJ-64300535 and Nucleos(t)ide Analogs (NA)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
14 sitesin 3 countries
Study dates
18 Apr 2018to 23 Mar 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
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Has chronic hepatitis B virus envelope antigen (HBeAg) negative hepatitis B virus (HBV) infection documented by a positive hepatitis B virus surface antigen (HBsAg) test and/or detectable HBV deoxyribonucleic acid (DNA) at least 6 months prior to the screening visit
  • Is on a stable treatment with one of the approved oral nucleos(t)ide analogs (NA) polymerase inhibitors tenofovir alafenamide, tenofovir disoproxil fumarate, or entecavir for greater than or equal to (>=)12 months prior to screening. A history of switching between the above treatments is acceptable as long as it was not triggered by virologic failure
  • Must demonstrate HBV DNA levels less than (<)60 international unit/milliliter (IU/mL) on 2 occasions separated by greater than (>)6 months (of which one can be the screening assessment).
  • Has HBsAg levels at screening between 100 IU/mL and 10,000 IU/mL
  • Has normal alanine aminotransferase (ALT) levels for at least 6 months prior to baseline with no documented measurement exceeding 1.25 times upper limit of normal [ULN]). Minimal requirement is documentation of two ALT results within the year prior to baseline of which one can be the screening assessment.

Who cannot join

  • Presence of advanced hepatic fibrosis or cirrhosis in 1 of the assessments below done less than or equal to (<=)6 month prior to baseline: a. Metavir score 3 or 4 in a liver biopsy OR b. Fibroscan result of >9 kilopascal (kPa) OR c. Acoustic Radiation Force Impulse (ARFI) result of >=1.55 meter/second (m/s)
  • Clinical signs or history of liver cirrhosis or hepatic decompensation:
  • Metavir score 4 in a historical biopsy OR
  • ascites, esophageal varices, or hepatic encephalopathy OR
  • documentation of one of the following laboratory abnormality within 12 months of screening:
  • direct (conjugated) bilirubin >1.2 times upper limit of normal (ULN) OR ii. prothrombin time (PT) >1.2 times ULN OR iii. serum albumin <3.5 gram per deciliter (g/dL)
Show all 17Show fewer
  • Positive serology test at screening for any of the following:
  • anti-hepatitis B surface (ant-HBs) antibodies
  • HBeAg
  • anti-human immunodeficiency virus (HIV)-1 or anti-HIV-2 antibodies
  • anti-hepatitis A virus (HAV) immunoglobulin M (IgM) antibodies
  • anti-hepatitis C virus (ant-HCV) antibodies
  • anti-hepatitis D virus (anti-HDV) antibodies
  • Participants with any evidence of liver disease of non-HBV etiology. This includes but is not limited to hepatitis A, C, or D virus infections (as above), drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cirrhosis, primary sclerosing cholangitis, non-alcoholic steatohepatitis or any other non-HBV liver disease considered clinically significant by the investigator
  • Has a history of persistent or recurrent hyperbilirubinemia unless explained by known Gilbert's Disease
  • History of blood disorders (bleeding problems or a blood clot, thalassemia major or sickle cell anemia).
  • History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions.

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

Germany6 sites

  • IFI Hamburg

    Hamburg

  • MH Hannover

    Hanover, Lower Saxony, 30625

  • UK Leipzig

    Leipzig

  • Ruprecht-Karls-U Mannheim

    Mannheim, Baden-Wurttemberg, 68167

  • Universität Regensburg

    Regensburg

  • Universitätsklinikum Essen

    UK Essen, North Rhine-Westphalia, 45122

Other trials in Germany

United Kingdom5 sites

  • Queen Elizabeth - Birmingham

    Birmingham, B15 2GW

  • Royal Free - London

    London, NW3 2PF

  • King's College - London

    London, SE5 9RS

  • Bart's Health - Blizard Inst. London

    London

  • Pennine Acute Hospitals - Manchester

    Manchester, E1 1BB

Other trials in United Kingdom

Belgium3 sites

  • ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg

    Antwerp

  • Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

    Brussels

  • Universite Libre de Bruxelles (ULB) - Hopital Erasme

    Brussels

Other trials in Belgium

About this study

Official title: A First-In-Human, Double-Blind, Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, Reactogenicity, and Immunogenicity of JNJ-64300535, a DNA Vaccine, Administered by Electroporation-Mediated Intramuscular Injection, in Participants With Chronic Hepatitis B Who Are on Stable Nucleos(T)Ide Therapy and Virologically Suppressed

The purpose of this study is to evaluate the safety, tolerability, and reactogenicity of escalating doses of JNJ-64300535 delivered via electroporation-mediated intramuscular injection in nucleos(t)ide analogs (NA)-treated chronic hepatitis B (CHB) participants.

Being tested
JNJ-64300535, Placebo, Nucleos(t)ide Analogs (NA)
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JNJ-64300535Biological

    Participants will receive JNJ-64300535 vaccine by electroporation-mediated IM injection on Day 1, Week 4, and Week 12.

  • PlaceboBiological

    Participants will receive 1 mL (0.9 percent [%] sodium chloride [NaCl]) of placebo solution matching to JNJ-64300535 electroporation-mediated IM injection on Day 1, Week 4, and Week 12.

  • Nucleos(t)ide Analogs (NA)Drug

    Participants will receive NA as a standard of care treatment.

Study groups in NCT03463369
Study groupRoleWhat they receive
Placebo + Nucleos(t)ide Analogs (NA)ExperimentalParticipants will receive placebo intramuscular (IM) injection on Day 1, Week 4, and Week 12, along with standard of care NA treatment.
Receives: Biological: Placebo; Drug: Nucleos(t)ide Analogs (NA)
JNJ-64300535 + NAExperimentalParticipants will receive JNJ-64300535 IM injection on Day 1, Week 4, and Week 12, along with standard of care NA treatment.
Receives: Biological: JNJ-64300535; Drug: Nucleos(t)ide Analogs (NA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Adverse Events (AEs) by Severity and Relationship to Study Treatment and Dose Level

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of AEs will be graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events as follows: Mild = Grade 1, Moderate = Grade 2, Severe = Grade 3, Potentially life-threatening = Grade 4.

    Measured: Up to Week 16

  2. Number of Participants With Laboratory Abnormalities

    Number of participants with laboratory abnormalities related to hematology, serum chemistry, coagulation, liver function tests and urinalysis will be reported. Laboratory abnormalities will be graded according to the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events as follows: Mild = Grade 1, Moderate = Grade 2, Severe = Grade 3, Potentially life-threatening = Grade 4.

    Measured: Up to Week 16

  3. Number of Participants With Clinically Significant Changes in Vital Signs

    Number of participants with clinically significant changes in the vital signs including blood pressure, pulse/heart rate, and body temperature will be reported.

    Measured: Up to Week 16

  4. Number of Participants With Clinically Significant Changes in Physical Examination (Palpation of Lymph Nodes, Height, Body Weight, and Skin Examination) Findings

    Number of participants with clinically significant changes in physical examination parameters will be reported. Full physical examination (including palpation of lymph nodes, height, body weight, and skin examination) and symptom-directed physical examination will be performed.

    Measured: Up to Week 16

  5. Number of Participants With Acute Injection Site Reactions on Day 1

    Participants will be assessed for the acute injection site reactions. Acute reactions means the reactions which occur within 0 to 2 hours post-vaccination. Acute reactions will be graded as follows: Grade 0 = Normal, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life Threatening.

    Measured: From 0 to 2 hours post-vaccination on Day 1

  6. Number of Participants With Acute Injection Site Reactions at Week 4

    Participants will be assessed for the acute injection site reactions. Acute reactions means the reactions which occur within 0 to 2 hours post-vaccination. Acute reactions will be graded as follows: Grade 0 = Normal, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life Threatening.

    Measured: From 0 to 2 hours post-vaccination at Week 4

  7. Number of Participants With Acute Injection Site Reactions at Week 12

    Participants will be assessed for the acute injection site reactions. Acute reactions means the reactions which occur within 0 to 2 hours post-vaccination. Acute reactions will be graded as follows: Grade 0 = Normal, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life Threatening.

    Measured: From 0 to 2 hours post-vaccination at Week 12

  8. Number of Participants With Injection Site Reactions After Vaccination on Day 1

    Participants will be assessed for the Reactogenicity. Reactogenicity means injection site reactions which occur after 7 days post- vaccination. Severity of reactions will be graded as follows: Grade 0 = Normal, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life Threatening.

    Measured: Up to 7 days post-vaccination on Day 1

  9. Number of Participants With Injection Site Reactions After Vaccination on Week 4

    Participants will be assessed for the Reactogenicity. Reactogenicity means injection site reactions which occur after 7 days post-vaccination. Severity of reactions will be graded as follows: Grade 0 = Normal, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life Threatening.

    Measured: Up to 7 days post-vaccination on Week 4

  10. Number of Participants With Injection Site Reactions After Vaccination on Week 12

    Participants will be assessed for the Reactogenicity. Reactogenicity means injection site reactions which occur after 7 days post- vaccination. Severity of reactions will be graded as follows: Grade 0 = Normal, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Potentially Life Threatening.

    Measured: Up to 7 days post-vaccination on Week 12

Secondary outcomes (5)

  1. Percentage of Participants With a Positive Hepatitis B Virus (HBV) Specific T Cells Response

    Percentage of participants with a positive HBV-specific T cells response, assessed by interferon (IFN)-gamma ELISpot assay will be reported.

    Measured: Day 1, Week 2, 6, 14, 24, 48, and 60

  2. Time to Detection of HBV Specific T-Cell Responses

    Time to HBV Specific T-Cell response is defined as the time interval between Day 1 (vaccination) to the date of first evidence of positive HBV Specific T-Cell response.

    Measured: Day 1 up to Week 60

  3. Percentage of CD4+ and CD8+ T-Cell Responses

    The activation of CD4+ and CD8+ T-cell subsets and their cytokine expression patterns (expressing at least 1 interleukin [IL]-2, tumor necrosis factor-alpha [TNF-α] or IFN-γ specific to any antigen) will be determined by Intracellular Cytokine Staining (ICS).

    Measured: Day 1, Week 2, 6, 14, 24, 48, and 60

  4. Hepatitis B Antigen-Specific Cellular Immune Response

    Magnitude of Hepatitis B antigen-specific cellular immune responses will be assessed by ICS.

    Measured: Day 1, Week 2, 6, 14, 24, 48, and 60

  5. Number of TriGrid Delivery System (TDS)-Intramuscular (IM) v2.0 Device Fault Conditions by Type

    Number of TDS-IM v2.0 device fault conditions by type will be observed. User reported fault conditions will be documented to enable assessment of the device reliability. Device functions to be assessed include electrode/needle deployment, study treatment administration, and electroporation application.

    Measured: Day 1, Week 4 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2018
  2. Study start18 Apr 2018
  3. Primary completion23 Mar 2021
  4. Study completion23 Mar 2021

Resources

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
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03463369
Sponsor's protocol ID
64300535HPB1001
Other IDs
64300535HPB1001, 2017-000147-41, 2017
Status last verified
Apr 2021
First submitted
28 Feb 2018
Last updated
14 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-64300535 and Nucleos(t)ide Analogs (NA) in people with Hepatitis B, Chronic, run by Janssen Sciences Ireland UC at 14 sites in 3 countries.

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 5 inclusion and 17 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 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Germany, United Kingdom, 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?

Number of Participants with Adverse Events (AEs) by Severity and Relationship to Study Treatment and Dose Level (time frame: Up to Week 16). The study lists 10 primary outcomes in all. 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 NCT03463369, 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 14 Apr 2021.

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