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

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ClinicalTrials.gov Identifier: NCT04642638
Recruitment Status : Active, not recruiting
First Posted : November 24, 2020
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 23, 2020
First Posted Date  ICMJE November 24, 2020
Last Update Posted Date March 29, 2021
Actual Study Start Date  ICMJE November 30, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • 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 ]
  • Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay [ Time Frame: Baseline up to Day 393 ]
  • Phase 3: Percentage of Participants 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2020)
  • 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) ]
  • 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) ]
  • Phase 2 and 3: Percentage of Participants With Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 393 ]
  • Phase 2 and 3: Percentage of Participants With Adverse Events of Special Interest (AESIs) [ Time Frame: Baseline up to Day 393 ]
  • Phase 3: Percentage of Participants With Death From All Causes [ Time Frame: Baseline up to Day 393 ]
  • Phase 3: Percentage of Participants 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) ]
  • Phase 3: Percentage of Participants 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) ]
  • Phase 3: Percentage of Participants 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) ]
  • Phase 3: Percentage of Participants With Virologically-Confirmed SARS-CoV-2 Infections [ 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) ]
  • Phase 3: Days to Symptom Resolution in Participants With 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) ]
  • Phase 3: Change From Baseline in Antigen-specific Cellular Immune Response Measured by IFN-gamma ELISpot Assay [ Time Frame: Baseline up to Day 393 ]
  • Phase 3: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay [ Time Frame: Baseline up to Day 393 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure
Official Title  ICMJE 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 Healthy Seronegative Adults at High Risk of SARS-CoV-2 Exposure
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 disease 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 6178 participants.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Coronavirus Infection
  • Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
  • COVID-19 Disease
Intervention  ICMJE
  • 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: SSC-0001
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: INO-4800
    • Device: CELLECTRA® 2000
  • 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.
    Interventions:
    • Drug: INO-4800
    • Device: CELLECTRA® 2000
  • 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.
    Interventions:
    • Drug: Placebo
    • Device: CELLECTRA® 2000
  • 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.
    Interventions:
    • Drug: Placebo
    • Device: CELLECTRA® 2000
  • Experimental: Phase 3: INO-4800 Optimum Dose Group
    Participants will receive either one or two 1.0 mg ID injections of INO-4800 based on results from Phase 2 segment, followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
    Interventions:
    • Drug: INO-4800
    • Device: CELLECTRA® 2000
  • Placebo Comparator: Phase 3: Placebo Optimum Dose Group
    Participants will receive either one or two ID injections of placebo based on results from Phase 2 segment, followed by EP using the CELLECTRA® 2000 device on Day 0 and Day 28.
    Interventions:
    • Drug: Placebo
    • Device: CELLECTRA® 2000
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: February 19, 2021)
401
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2020)
6578
Estimated Study Completion Date  ICMJE September 2022
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • 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.

Key Exclusion Criteria:

  • Acute febrile illness with temperature higher than 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.
  • 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.
  • 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 receipt of an investigational 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04642638
Other Study ID Numbers  ICMJE COVID19-311
INNOVATE ( Other Identifier: Inovio INO-4800 Vaccine Trial for Efficacy )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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.
Responsible Party Inovio Pharmaceuticals
Study Sponsor  ICMJE Inovio Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mammen P. Mammen Jr, M.D., FACP, FIDSA Inovio Pharmaceuticals
PRS Account Inovio Pharmaceuticals
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP