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| Name | Class |
|---|---|
| Coalition for Epidemic Preparedness Innovations | OTHER |
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This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INO-4500 Group A | Experimental | Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device |
|
| Placebo Comparator Group A | Placebo Comparator | Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device |
|
| INO-4500 Group B | Experimental | Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device |
|
| Placebo Comparator Group B | Placebo Comparator | Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INO-4500 | Drug | INO-4500 will be administered ID on Day 0 and Week 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) | Baseline up to Week 48 | |
| Percentage of Participants with Injection Site Reactions | Day 0 up to Week 48 | |
| Incidence of adverse events of special interest | Baseline up to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Antigen Specific Binding Antibody titers | Day 0 up to Week 48 | |
| Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies | Day 0 up to Week 48 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mammen Mammen, MD, FACP, FIDSA | Inovio Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study.
Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.
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| ID | Term |
|---|---|
| D007835 | Lassa Fever |
| ID | Term |
|---|---|
| D001117 | Arenaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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The Sponsor will be blinded up to Week 6; at that time the Sponsor will become group-level unblinded.
| Placebo | Drug | Placebo will be administered ID on Day 0 and Week 4. |
|
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| CELLECTRA® 2000 | Device | EP using the CELLECTRA® 2000 device will be administered following ID drug administration. |
|
| Change from Baseline in Interferon-Gamma Response Magnitude |
| Day 0 up to Week 48 |
| D006482 |
| Hemorrhagic Fevers, Viral |