Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Adults at High Risk of SARS-CoV-2 Exposure

Inovio Pharmaceuticals Inc.0 sites7,116 target enrollmentSeptember 10, 2021

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Inovio Pharmaceuticals Inc.
Enrollment: 7116
Status: Other
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 10, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Inovio Pharmaceuticals Inc.

Eligibility Criteria

Inclusion Criteria

•Working or residing in an environment with high risk of exposure to SARS\-CoV\-2 for whom exposure may be relatively prolonged or for whom personal protective equipment (PPE) may be inconsistently used, especially in confined settings.
•Phase 2 only: Screening laboratory results within normal limits for testing laboratory or are deemed not clinically significant by the Investigator.
•Be post\-menopausal or be surgically sterile or have a partner who is sterile or use medically effective contraception with a failure rate of \< 1% per year when used consistently and correctly from Screening until 3 months following last dose (Phase 2\) or until last dose (Phase 3\).

Exclusion Criteria

•Acute febrile illness with temperature higher than or equal to 100\.4°F (38\.0°C) or acute onset of upper or lower respiratory tract symptoms.
•Positive serologic or molecular (Reverse transcription polymerase chain reaction (RT\-PCR)) test for SARS\-CoV\-2 at Screening (this criterion applies to all Phase 2 participants and only applies after approximately 402 participants positive for SARS\-CoV\-2 serologic test are randomized in the Phase 3 segment of the study).
•Pregnant or breastfeeding or intending to become pregnant or intending to father children within the projected duration of the trial starting from the Screening visit until 3 months following the last dose (Phase 2\) or until last dose (Phase 3\).
•Known history of uncontrolled HIV based on a CD4 count less than 200 cells per cubic millimeter (/mm^3\) or a detectable viral load within the past 3 months.
•Is currently participating or has participated in a study with an investigational product within 30 days preceding Day 0\.
•Previous or planned receipt of an investigational (including Emergency Use Authorization (EUA) or local equivalent authorization) or licensed vaccine for prevention or treatment of COVID\-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS) (documented receipt of placebo in previous trial would be permissible for trial eligibility).
•Respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease) requiring significant changes in therapy or hospitalization for worsening disease during the 6 weeks prior to enrolment.
•Immunosuppression as a result of underlying illness or treatment.
•Lack of acceptable sites available for ID injection and EP.
•Blood donation or transfusion within 1 month prior to Day 0\.