Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure
Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
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 COVID-19 in
participants at high risk of exposure to 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.