Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure
Summary
This is a Phase 2/3, randomized, placebo-controlled, multi-center trial to evaluate the safety, immunogenicity and efficacy of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device to prevent coronavirus disease 2019 (COVID-19) in participants at high risk of exposure to severe acute respiratory syndrome coronavirus - 2 (SARS-CoV-2). The Phase 2 segment will evaluate immunogenicity and safety in approximately 400 participants at two dose levels across three age groups. Safety and immunogenicity information from the Phase 2 segment will be used to determine the dose level for the Phase 3 efficacy segment of the study involving approximately 7116 participants.
Timeline
- Start
- 2020-11-30
- Primary completion
- 2022-09-13
- Completion
- 2022-09-13
Outcome
Mixed primary results
Stopped (Business): “The study was terminated to prioritize Inovio's COVID-19 efforts to advance a heterologous booster strategy and optimize potential impact on global public health.”
registry Difference in median 6.70 (95% CI 0.00 to 6.70) NCT04642638 ↗
registry Difference in median 13.30 (95% CI 3.30 to 17.80) NCT04642638 ↗
registry GMFR Ratio 2.50 (95% CI 1.720 to 3.632) NCT04642638 ↗
registry GMFR Ratio 3.88 (95% CI 2.638 to 5.700) NCT04642638 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RELUSCOVTOGENE RALAPLASMID | Vaccine | 1 mg | Other |
| Subject | RELUSCOVTOGENE RALAPLASMID | Vaccine | 2 mg | Other |