Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-64300535 · 2 trials · 2 indications
Percentage of participants responding against HBV Core or Pol vaccine antigens will be reported.
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 |
|---|---|---|
| JNJ-64300535 | EXPERIMENTAL | Participants will receive an electroporation-mediated intramuscular (IM) injection of JNJ-64300535 vaccine. |
| 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 | JNJ-64300535 injection will be administered intramuscularly. |
| 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: * 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 protoco...
JNJ-64300535 is an investigational DNA vaccine being studied for chronic hepatitis B and in healthy participants. It is administered by electroporation-mediated intramuscular injection. In chronic hepatitis B, it is being evaluated in patients on stable nucleos(t)ide therapy who are virologically suppressed.
JNJ-64300535 is being developed by Johnson & Johnson, traded on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials of this investigational DNA vaccine in participants with chronic hepatitis B and in healthy volunteers.
JNJ-64300535 is in Phase 1 clinical development. It is an investigational DNA vaccine and has not been approved by regulatory authorities. Two Phase 1 studies have been completed, one in chronic hepatitis B patients and one in healthy participants.
JNJ-64300535 has been studied in two completed Phase 1 trials. NCT03463369 evaluated the vaccine in 30 participants with chronic hepatitis B in Belgium, Germany, and the United Kingdom. NCT04736147 evaluated it in 14 healthy male participants in Belgium.
JNJ-64300535 is a DNA vaccine administered by electroporation-mediated intramuscular injection. It is designed to induce an immune response against hepatitis B. The vaccine is being studied in patients with chronic hepatitis B who are virologically suppressed on nucleos(t)ide therapy.