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| Name | Class |
|---|---|
| Coalition for Epidemic Preparedness Innovations | OTHER |
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This is a randomized, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.
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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. |
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| 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 in two acceptable locations in two different limbs at each dosing visit. |
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| Placebo Group C | Placebo Comparator | Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device. |
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| Placebo Group D | Placebo Comparator | Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INO-4500 | Drug | INO-4500 will be administered ID on Day 0 and Week 4. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Baseline up to Week 48 | |
| Number of Participants with Injection Site Reactions | Day 0 up to Week 48 | |
| Number of Participants with Adverse Events of Special Interest (AESIs) | Baseline up to Week 48 | |
| Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies | Day 0 up to Week 48 | |
| Change from Baseline in Lassa virus (LASV) Neutralization Assays | Day 0 up to Week 48 | |
| Change from Baseline in Interferon-Gamma Response Magnitude | Day 0 up to Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bonaventure Orizu, MD | Inovio Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noguchi Memorial Institute for Medical Research, University of Ghana | Legon | Accra | Ghana |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41208990 | Derived | Koram KA, Walker KA, Orizu B, Marrero I, Boyer J, Yang S, Broderick KE, Kusi KA, Kyei-Baafour E, Ofori EA, Pobee A, Adu-Amankwah S, Amoakoh-Coleman M, Amoakoh HB, Abuaku B, Badji E, Ntiri M, Quaye L, Morrow MP, Sylvester AJ, Reuschel EL, Gillespie E, Liebowitz D, Humeau LM. Safety, tolerability, and immunogenicity of INO-4500, a synthetic DNA-based vaccine against Lassa virus, in a phase 1b clinical trial in healthy Ghanaian adults. Front Immunol. 2025 Oct 24;16:1658549. doi: 10.3389/fimmu.2025.1658549. eCollection 2025. |
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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 two (2) 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.
| CELLECTRA™ 2000 | Device | EP using the CELLECTRA™ 2000 device will be administered following ID drug administration. |
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| Placebo | Drug | Placebo will be administered ID on Day 0 and Week 4. |
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| D006482 |
| Hemorrhagic Fevers, Viral |