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
NCT ID: NCT03463369
Last Updated: 2021-04-14
Study Results
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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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2018-04-18
2021-03-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
TRIPLE
Study Groups
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Placebo + Nucleos(t)ide Analogs (NA)
Participants will receive placebo intramuscular (IM) injection on Day 1, Week 4, and Week 12, along with standard of care NA treatment.
Placebo
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)
Participants will receive NA as a standard of care treatment.
JNJ-64300535 + NA
Participants will receive JNJ-64300535 IM injection on Day 1, Week 4, and Week 12, along with standard of care NA treatment.
JNJ-64300535
Participants will receive JNJ-64300535 vaccine by electroporation-mediated IM injection on Day 1, Week 4, and Week 12.
Nucleos(t)ide Analogs (NA)
Participants will receive NA as a standard of care treatment.
Interventions
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JNJ-64300535
Participants will receive JNJ-64300535 vaccine by electroporation-mediated IM injection on Day 1, Week 4, and Week 12.
Placebo
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)
Participants will receive NA as a standard of care treatment.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Clinical signs or history of liver cirrhosis or hepatic decompensation:
1. Metavir score 4 in a historical biopsy OR
2. ascites, esophageal varices, or hepatic encephalopathy OR
3. documentation of one of the following laboratory abnormality within 12 months of screening:
i. 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)
* Positive serology test at screening for any of the following:
1. anti-hepatitis B surface (ant-HBs) antibodies
2. HBeAg
3. anti-human immunodeficiency virus (HIV)-1 or anti-HIV-2 antibodies
4. anti-hepatitis A virus (HAV) immunoglobulin M (IgM) antibodies
5. anti-hepatitis C virus (ant-HCV) antibodies
6. 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.
18 Years
55 Years
ALL
No
Sponsors
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Janssen Sciences Ireland UC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Sciences Ireland UC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Sciences Ireland UC
Locations
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ZiekenhuisNetwerk Antwerpen (ZNA) - Stuivenberg
Antwerp, , Belgium
Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc
Brussels, , Belgium
Universite Libre de Bruxelles (ULB) - Hopital Erasme
Brussels, , Belgium
Ruprecht-Karls-U Mannheim
Mannheim, Baden-Wurttemberg, Germany
MH Hannover
Hanover, Lower Saxony, Germany
Universitätsklinikum Essen
UK Essen, North Rhine-Westphalia, Germany
IFI Hamburg
Hamburg, , Germany
UK Leipzig
Leipzig, , Germany
Universität Regensburg
Regensburg, , Germany
Queen Elizabeth - Birmingham
Birmingham, , United Kingdom
Royal Free - London
London, , United Kingdom
King's College - London
London, , United Kingdom
Bart's Health - Blizard Inst. London
London, , United Kingdom
Pennine Acute Hospitals - Manchester
Manchester, , United Kingdom
Countries
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Other Identifiers
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64300535HPB1001
Identifier Type: OTHER
Identifier Source: secondary_id
2017-000147-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
64300535HPB1001
Identifier Type: -
Identifier Source: org_study_id
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