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Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04642638
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : November 2, 2021
Sponsor:
Collaborator:
Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Brief 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.


Condition or disease Intervention/treatment Phase
Coronavirus Infection Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) COVID-19 Disease Drug: INO-4800 Device: CELLECTRA® 2000 Drug: Placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7517 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 30, 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 2: INO-4800 Dose Group 1
Participants will receive one intradermal (ID) injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
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.

Experimental: Phase 2: INO-4800 Dose Group 2
Participants will receive 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.
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.

Placebo Comparator: Phase 2: Placebo Dose Group 1
Participants will receive one ID injection of placebo followed by EP using the CELLECTRA® 2000 device 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 Names:
  • SSC-0001
  • Placebo for INO-4800

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.

Placebo Comparator: Phase 2: Placebo Dose Group 2
Participants will receive two ID injections of placebo followed by EP using the CELLECTRA® 2000 device 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 Names:
  • SSC-0001
  • Placebo for INO-4800

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.

Experimental: Phase 3: INO-4800 Dose Group (2.0mg per dosing visit)
Participants will receive two 1.0 mg ID injections of INO-4800, each followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
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.

Placebo Comparator: Phase 3: Placebo Dose Group
Participants will receive two ID injections of placebo per dosing visit, each followed by EP using the CELLECTRA® 2000 device 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 Names:
  • SSC-0001
  • Placebo for INO-4800

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.




Primary Outcome Measures :
  1. Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-γ) Enzyme-linked Immunospot (ELISpot) Assay [ Time Frame: Baseline up to Day 393 ]
  2. Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay [ Time Frame: Baseline up to Day 393 ]
  3. Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Virologically-confirmed COVID-19 Disease [ Time Frame: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393) ]

Secondary Outcome Measures :
  1. Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Injection Site Reactions [ Time Frame: From time of consent up to 28 days post-dose 2 (up to Day 56) ]
  2. Phase 2 and 3: Percentage of Participants With Solicited and Unsolicited Systemic Adverse Events (AEs) [ Time Frame: From time of consent up to 28 days post-dose 2 (up to Day 56) ]
  3. Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 393 ]
  4. Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to Day 393 ]
  5. Phase 3: Percentage of Participants With Death From All Causes [ Time Frame: Baseline up to Day 393 ]
  6. Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Non-Severe COVID-19 Disease [ Time Frame: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393) ]
  7. Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Severe COVID-19 Disease [ Time Frame: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393) ]
  8. Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Death From COVID-19 Disease [ Time Frame: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393) ]
  9. Phase 3: Percentage of Participants, (SARS-CoV-2 seropositive at baseline), With Virologically-Confirmed SARS-CoV-2 COVID-19 Disease [ Time Frame: From 14 days after completion of the 2-dose regimen up to 12 months post-dose 2 (i.e. Day 42 up to Day 393) ]
  10. Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay [ Time Frame: Baseline up to Day 393 ]
  11. Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay [ Time Frame: Baseline up to Day 393 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642638


Contacts
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Contact: Inovio Call Center (267) 440-4237 clinical.trials@inovio.com

Locations
Show Show 34 study locations
Sponsors and Collaborators
Inovio Pharmaceuticals
Advaccine (Suzhou) Biopharmaceuticals Co., Ltd.
Investigators
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Study Director: Mammen P. Mammen Jr, M.D., FACP, FIDSA Inovio Pharmaceuticals
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Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04642638    
Other Study ID Numbers: COVID19-311
INNOVATE ( Other Identifier: Inovio INO-4800 Vaccine Trial for Efficacy )
WHO UTN: U1111-1266-9952 ( Other Identifier: World Health Organization (WHO) )
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Anonymous IPD may be shared following or during the publication of summary data. Archival data may be accessed for up to 10 years following the end of the study.
Access Criteria: Those who request the anonymous IPD must provide a plan of study explaining how the data will be used. Requests may be sent to the Central Contact Person. Requests will be reviewed based on the potential for the planned use of the IPD for advancing scientific knowledge and theory.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Inovio Pharmaceuticals:
DNA vaccine
Electroporation
Healthy
COVID-19
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases