Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure
NCT ID: NCT04642638
Last Updated: 2023-12-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
1307 participants
INTERVENTIONAL
2020-11-30
2022-09-13
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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Phase 2: INO-4800 Dose Group 1
Participants received one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
INO-4800
INO-4800 was administered ID on Day 0 and Day 28.
CELLECTRA® 2000
EP using the CELLECTRA® 2000 device was administered following ID delivery of INO-4800 on Day 0 and Day 28.
Phase 2: INO-4800 Dose Group 2
Participants received two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
INO-4800
INO-4800 was administered ID on Day 0 and Day 28.
CELLECTRA® 2000
EP using the CELLECTRA® 2000 device was administered following ID delivery of INO-4800 on Day 0 and Day 28.
Phase 2: Placebo Dose Group 1
Participants received one ID injection of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID on Day 0 and Day 28.
CELLECTRA® 2000
EP using the CELLECTRA® 2000 device was administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.
Phase 2: Placebo Dose Group 2
Participants received 2 ID injections of placebo followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID on Day 0 and Day 28.
CELLECTRA® 2000
EP using the CELLECTRA® 2000 device was administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.
Phase 3: INO-4800 Dose Group (2.0mg per dosing visit)
Participants received two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
INO-4800
INO-4800 was administered ID on Day 0 and Day 28.
CELLECTRA® 2000
EP using the CELLECTRA® 2000 device was administered following ID delivery of INO-4800 on Day 0 and Day 28.
Phase 3: Placebo Dose Group
Participants received 2 ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID on Day 0 and Day 28.
CELLECTRA® 2000
EP using the CELLECTRA® 2000 device was administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.
Interventions
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INO-4800
INO-4800 was administered ID on Day 0 and Day 28.
CELLECTRA® 2000
EP using the CELLECTRA® 2000 device was administered following ID delivery of INO-4800 on Day 0 and Day 28.
Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) was administered ID on Day 0 and Day 28.
CELLECTRA® 2000
EP using the CELLECTRA® 2000 device was administered following ID delivery of sterile saline sodium citrate (SSC) buffer (SSC-0001) on Day 0 and Day 28.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 human immunodeficiency virus (HIV) based on clusters of differentiation (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.
18 Years
ALL
Yes
Sponsors
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Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
INDUSTRY
Inovio Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Jose Suaya
Role: STUDY_DIRECTOR
Inovio Pharmaceuticals
Locations
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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 Department, Colombia
BRCR Global Mexico
Guadalajara, Jalisco, Mexico
Eukarya Pharmasite SC
Monterrey, Nuevo León, 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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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INNOVATE
Identifier Type: OTHER
Identifier Source: secondary_id
WHO UTN: U1111-1266-9952
Identifier Type: OTHER
Identifier Source: secondary_id
COVID19-311
Identifier Type: -
Identifier Source: org_study_id