Safety, Tolerability and Immunogenicity of INO-4800 Followed by Electroporation in Healthy Volunteers for COVID19
Condition: Coronavirus Infection; SARS-CoV 2
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I/IIa trial to evaluate the safety, tolerability and immunological profile of
      INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using
      the CELLECTRA® 2000 device in healthy adults aged 19 to 64 years in Republic of Korea. INO-
      4800 contains the plasmid pGX9501, which encodes for the full length of the Spike
      glycoprotein of SARS-CoV-2. The primary objective of this trial is to evaluate the
      tolerability, safety, and immunogenicity of INO-4800 administered by ID injection followed by
      EP in healthy adults in the Part A and Part B. Enrollment into Part A, and Part B will
      proceed sequentially.
    

Detailed description: 
      [Part A] Part A is open-label, dose-ranging study, enrolling total of 40 subjects. Part A is
      divided into two arm, low dose (Group 1) and high dose (Group 2). The subjects will be
      contacted by telephone to report adverse events or other reactions the day following the
      first vaccination. Once these first five subjects in Group 1 complete the Week 1 visit, all
      available clinical laboratory and adverse event data will be reviewed by the Data Safety
      Monitoring Board (DSMB). Further enrollment into Group 1 will be paused during this DSMB
      review. If DSMB determines there are no safety findings judged to be of clinical concern and
      no dose limiting toxicities nor any stopping events observed, enrollment will be opened for
      the remaining subjects in Group 1. Once Group 1 enrollment is completed [i.e., 20 total
      subjects enrolled], Group 2 will open to enrollment. Daily safety assessment of all enrolled
      subjects will be supported by the Study Medical Monitor on an ongoing basis while the first
      five subjects are being enrolled, if needed. The subjects will be contacted by telephone to
      report adverse events or other reactions the day following the first vaccination. Once the
      first five subjects Group 2 complete the Week 1 visit, all available clinical laboratory and
      adverse event data from these first five subjects, along with the safety data from subjects
      in Group 1, will be reviewed by the DSMB. However, enrollment may continue while this DSMB
      review is conducted, without any pause to enrollment of the remaining subjects in Group 2.

      Once all subjects in Part A Group 1 and Group 2 complete the Week 8 visit, all available
      clinical laboratory, adverse event, immunogenicity data from all subjects will be reviewed by
      the DSMB. The DSMB will additionally review serious adverse events (SAEs) and adverse events
      of special interest (AESIs) date throughout the study. With DSMB's recommendation, the
      optimal dose for Part B will be selected by the Sponsor based on the following criteria which
      may be adjusted over the course of the study. Percentage immunogenic seroconversionRelative
      immunogenicity between INO-4800 Study Arms (Low dose vs. High dose)Safety profile of each
      INO-4800 Study Arms (Low dose vs. High dose). All subjects will be followed for 48 weeks
      following the 2nd vaccination. Week 52 will be the End of Study (EOS) visit.

      [Part B] Part B is divided into two arm, IP Arm (Group 3) and Placebo Arm (Group 4). Part B
      will be randomized, double-blind, placebo-controlled trial, enrolling 60 subjects in IP arm,
      and 20 subjects in Placebo arm in 19-50 age group, and 30 subjects in IP arm, and 10 subjects
      in Placebo arm in 51-64 age group, for total of 90 subjects in IP arm, and 30 subjects in
      Placebo arm. At dosing visit, subjects will be randomized to either Group 3 or Group 4. The
      subjects will be contacted by telephone to report adverse events or other reactions the day
      following the first vaccination. DSMB review of safety findings will be performed according
      to the DSMB charter. All subjects will be followed for 48 weeks following the 2nd
      vaccination. Week 52 will be the End of Study (EOS) visit.Should the criteria for any dose
      limiting toxicity or stopping rule be met, at any time, further enrollment and administration
      of INO-4800 will be paused for further evaluation. The Sponsor will consult the DSMB, if
      needed, to determine whether to enroll and/or dose the remainder of the subjects. All
      subjects will be followed for 48 weeks following the 2nd vaccination. Week 52 will be the End
      of Study (EOS) visit.
    

Intervention name(s): INO-4800; CELLECTRA® 2000; Saline-sodium citrate (SSC) buffer
Intervention type(s): Biological; Device; Other
Intervention description(s): - Manufacturer: Inovio Pharmaceuticals Inc.; - Manufacturer: Inovio Pharmaceuticals Inc.; - Manufacturer: Inovio Pharmaceuticals Inc.
Other intervention name(s): Placebo
Intervention MeSH terms: Citric Acid; Sodium Citrate
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Coronavirus Infection; SARS-CoV 2; INO-4800