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.
Drug: INO-4800
INO-4800 will be administered ID on Day 0 and Day 28.
Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0 and Day 28.
Drug: Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID on Day 0 and Day 28.
Other Name: Array
Device: CELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.
Key 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).
Key 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 (e.g., cough, shortness of
breath, sore throat).
- 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.
- Reported alcohol or substance abuse or dependence, or illicit drug use (excluding
marijuana use).
- Any illness or condition that in the opinion of the investigator may affect the safety
of the participant or the evaluation of any study endpoint.
Synexus Clinical Research US, Inc - Phoenix Southeast
Chandler, Arizona, United States
Central Phoenix Synexus Clinical Research
Phoenix, Arizona, United States
AMR Tempe
Tempe, Arizona, United States
Optimal Research, LLC
San Diego, California, United States
AMR South Florida
Coral Gables, Florida, United States
Clinical Research Trials of Florida, Inc
Tampa, Florida, United States
AMR Lexington
Lexington, Kentucky, United States
Walter Reed Army Institute of Research
Silver Spring, Maryland, United States
Ascension St. John Hospital
Detroit, Michigan, United States
AMR Kansas City
Kansas City, Missouri, United States
AMR, Clinical Research Consortium- Las Vegas
Las Vegas, Nevada, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
Tekton Research
San Antonio, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Advanced Clinical Research
West Jordan, Utah, United States
Centro de Investigacion Medico Asistencial S.A.S
Barranquilla, Atlántico, Colombia
Clinica de la Costa LTDA
Barranquilla, Atlántico, Colombia
Corazon IPS S.A.S
Barranquilla, Atlántico, Colombia
Ips Centro Cientifico Asistencial Sas
Barranquilla, Atlántico, Colombia
Centro de Investigaciones Clinicas IPS Cardiomet Pereira
Pereira, Risaralda, Colombia
BRCR Global Mexico
Guadalajara, Jalisco, Mexico
Eukarya Pharmasite SC
Monterrey, Nuevo Leon, Mexico
Unidad de Medicina Especializada SMA
San Juan del Río, Querétaro, Mexico
Clinstile, SA de CV
Mexico City, Mexico
SMIQ, S. de R. L. de C.V.
Querétaro, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, Mexico
Bonaventure Orizu, MD, Study Director
Inovio Pharmaceuticals