Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INO-4201 · 2 trials · 2 indications
Primary safety outcome
Primary immunogenicity outcome
Composite of multiple measures consist of: * Frequency and severity of all adverse events * Local pain immediately and at 5 and 10 minutes after Study Treatment/EP using a visual analog scale from 0 to 10, with 0 representing "No Pain" and 10 representing "Worst Pain" * Frequency and severity of local and systemic events for at least 7 days after Study Treatment/EP * Frequency and severity of laboratory abnormalities * Changes in vital signs (blood pressure, heart rate, respiratory rate, temperature)
| Arm | Type | Description |
|---|---|---|
| INO-4201 | EXPERIMENTAL | One intradermal injection of INO-4201 followed by electroporation |
| Placebo | PLACEBO_COMPARATOR | One intradermal injection of normal saline followed by electroporation |
| Group 1 | EXPERIMENTAL | INO-4201 IM + EP, 2 mg, 3 doses |
| Group 2 | EXPERIMENTAL | INO-4202 IM + EP, 2 mg, 3 doses |
| Group 3 | EXPERIMENTAL | INO-4201 ID + EP 0.2A, 2 mg, 3 doses |
| Group 4 | EXPERIMENTAL | INO-4212 IM + EP, 4 mg, 3 doses |
| Group 5 | EXPERIMENTAL | INO-4212 + INO-9012 IM + EP, 4+1 mg, 3 doses |
| Group 6 | EXPERIMENTAL | INO-4201 ID + EP 0.2A, 1 mg, 3 doses |
| Group 7 | EXPERIMENTAL | INO-4201 ID + EP 0.2A, 2 mg, 2 doses |
| Group 8 | EXPERIMENTAL | INO-4201 ID + EP 0.2A, 1 mg, 2 doses |
| Group 9 | EXPERIMENTAL | INO-4201 + INO-9012 ID + EP 0.2A, 1.6 + 0.4 mg, 3 doses |
| Group 10 | EXPERIMENTAL | INO-4201 + INO-9012 ID + EP 0.2A, 1.6 + 0.4 mg, 2 doses |
| Group 11 | EXPERIMENTAL | INO-4201 + INO-9012 ID + EP 0.2A, 0.8 + 0.2 mg, 3 doses |
| Part II: Group 3A | EXPERIMENTAL | INO-4201 ID + EP 0.2A, 2 mg, 3 doses |
| Part II: Group 3B | EXPERIMENTAL | INO-4201 ID + EP 0.1A, 2 mg, 3 doses |
| Name | Type | Description |
|---|---|---|
| INO-4201 | BIOLOGICAL | One dose of 1 mg of INO-4201 in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000 |
| Placebo | BIOLOGICAL | One dose of normal saline in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000 |
| INO-4202 | BIOLOGICAL | INO-4202 delivered IM followed by Electroporation |
| INO-4212 | BIOLOGICAL | INO-4212 delivered IM followed by Electroporation |
| INO-4212 + INO-9012 | BIOLOGICAL | INO-4212 + INO-9012 delivered IM followed by Electroporation |
| INO-4201 + INO-9012 | BIOLOGICAL | INO-4201 + INO-9012 delivered ID followed by Electroporation |
Inclusion Criteria: 1. Has provided written informed consent prior to screening 2. Males and females ≥ 18 years old 3. Previously vaccinated with a single dose of VSV-ZEBOV at any dose between 10\^5 and 10\^8 pfu more than 6 months prior to inclusion 4. Free of clinically significant health problem...
INO-4201 is an investigational Ebola vaccine being developed for the prevention of Ebola Virus Disease. It is currently in Phase 1 clinical development and has been studied in healthy volunteers as a booster vaccine in individuals previously vaccinated with VSV-ZEBOV.
INO-4201 is being developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INO. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity.
INO-4201 is in Phase 1 clinical development. It is an investigational Ebola vaccine and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, one of which evaluated INO-4201 as a booster in healthy VSV-ZEBOV vaccinees.
INO-4201 has been studied in two completed Phase 1 clinical trials. NCT02464670 evaluated INO-4212 with or without INO-9012 in 240 healthy volunteers in the United States. NCT04906629 evaluated INO-4201 as a booster in 46 healthy VSV-ZEBOV vaccinees in Switzerland.
INO-4201 is not the same as INO-4212. INO-4212 is a separate investigational vaccine candidate that was evaluated in a Phase 1 trial (NCT02464670) in healthy volunteers. INO-4201 was studied as a booster vaccine in a different Phase 1 trial (NCT04906629).