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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2022

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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)

Secondary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Inovio Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mammen P. Mammen Jr, M.D., FACP, FIDSA, Study Director, Inovio Pharmaceuticals

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