Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
| Registry | NCT03805984 |
|---|---|
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional; randomized, sequential, masking: triple, prevention |
| Enrollment | 60 (Actual) |
| Sponsor | Inovio Pharmaceuticals (Industry); collaborators: Coalition for Epidemic Preparedness Innovations |
| Conditions | Lassa Fever |
| Interventions | INO-4500, Placebo, CELLECTRA® 2000 (Drug, device) |
| Dates | start 2019-05-09, primary completion 2020-10-21, completion 2020-10-21, first posted 2019-01-16, last updated 2020-11-23 |
| Locations | 1 site in United States |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| INO-4500 Group A | Experimental | Drug: INO-4500; Device: CELLECTRA® 2000 | 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 | Drug: Placebo; Device: CELLECTRA® 2000 | Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device |
| INO-4500 Group B | Experimental | Drug: INO-4500; Device: CELLECTRA® 2000 | 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 | Drug: Placebo; Device: CELLECTRA® 2000 | Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device |
Sex: All, ages: 18 Years to 50 Years, accepts healthy volunteers
Inclusion Criteria: * Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening; * Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody; * Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome); * Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 6 months following last dose or be post-menopausal or be surgically sterile or have a partner who is sterile. Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 1 month following last dose; * Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0; * Previous receipt of an investigational vaccine product for prevention of Lassa Fever; * Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles; * Audiometry testing that demonstrates a hearing level threshold of 30 dB or greater for any frequency tested between 250 Hz - 8000 Hz; * Recent (within 6 months) or planned travel to Lassa-endemic region; * Current or anticipated concomitant immunosuppressive therapy.
| Facility | City | Country | Status |
|---|---|---|---|
| The Center for Pharmaceutical Research | Kansas City, Missouri | United States |