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

Conditions: Hepatitis B, Chronic

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.


Eligibility criteria:
inclusion criteria: * 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 (\ )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: * presence of advanced hepatic fibrosis or cirrhosis in 1 of the assessments below done less than or equal to (\ 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: 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.