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JNJ-64300535 · 1 trial · 1 indication
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.
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.
Number of participants with clinically significant changes in the vital signs including blood pressure, pulse/heart rate, and body temperature will be reported.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Placebo + Nucleos(t)ide Analogs (NA) | EXPERIMENTAL | Participants will receive placebo intramuscular (IM) injection on Day 1, Week 4, and Week 12, along with standard of care NA treatment. |
| JNJ-64300535 + NA | EXPERIMENTAL | Participants will receive JNJ-64300535 IM injection on Day 1, Week 4, and Week 12, along with standard of care NA treatment. |
| Name | Type | Description |
|---|---|---|
| JNJ-64300535 | BIOLOGICAL | Participants will receive JNJ-64300535 vaccine by electroporation-mediated IM injection on Day 1, Week 4, and Week 12. |
| Placebo | BIOLOGICAL | 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. |
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 ...
JNJ-64300535 is an investigational DNA vaccine developed by Johnson & Johnson for chronic hepatitis B. It is designed to be given by electroporation-mediated intramuscular injection to patients who are on stable nucleos(t)ide therapy and are virologically suppressed. It has completed a single Phase 1 first-in-human study.
JNJ-64300535 is being studied for chronic hepatitis B in adults who are already on stable nucleos(t)ide therapy and whose virus levels are virologically suppressed. The goal of the program is to evaluate the vaccine in that specific patient population rather than as a standalone treatment for all hepatitis B patients.
JNJ-64300535 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the first-in-human study of the candidate in chronic hepatitis B.
JNJ-64300535 is in Phase 1 development. Its only recorded trial, NCT03463369, was a Phase 1 first-in-human study that has been completed. The drug is investigational and has not been approved for any indication.
JNJ-64300535 has been evaluated in one clinical trial, NCT03463369, a completed Phase 1 first-in-human study. That randomized, double-blind, controlled trial enrolled 30 participants with chronic hepatitis B across Belgium, Germany, and the United Kingdom, and assessed safety, tolerability, reactogenicity, and immunogenicity.
In NCT03463369, JNJ-64300535 was given by electroporation-mediated intramuscular injection. The Phase 1 study enrolled 30 adults aged 18 years and older with chronic hepatitis B who were on stable nucleos(t)ide therapy and virologically suppressed, and it evaluated safety, tolerability, reactogenicity, and immunogenicity.