Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04447781
Study type Interventional
Source International Vaccine Institute
Contact
Status Completed
Phase Phase 1/Phase 2
Start date July 15, 2020
Completion date May 25, 2022

See also
  Status Clinical Trial Phase
Completed NCT04369456 - Blood Biomarkers as Predictors of COVID-19 Disease Progression in Recently Infected Kidney Transplant Patients N/A
Completed NCT04527471 - Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Recruiting NCT04410510 - P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19 Phase 2/Phase 3
Withdrawn NCT04383899 - Role of Ibuprofen and Other Medicines on Severity of Coronavirus Disease 2019
Completed NCT04542915 - COVID-19-Related Health and Practices Among Dental Hygienists
Not yet recruiting NCT04400019 - Prevention of COVID19 Infection in Nursing Homes by Chemoprophylaxis With Hydroxychloroquine (PREVICHARM) Phase 2/Phase 3
Terminated NCT04954014 - Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients Phase 2
Suspended NCT04385771 - Cytokine Adsorption in Patients With Severe COVID-19 Pneumonia Requiring Extracorporeal Membrane Oxygenation N/A
Completed NCT04532632 - Taste and Smell Impairment in Critically Ill COVID-19 Patients
Terminated NCT04530448 - Coronavirus Induced Acute Kidney Injury: Prevention Using Urine Alkalinization Phase 4
Completed NCT04413435 - Clinical Characteristics of Critically Ill Patients With COVID-19
Terminated NCT05593770 - International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response Phase 2/Phase 3
Completed NCT04510493 - Canakinumab in Patients With COVID-19 and Type 2 Diabetes Phase 3
Active, not recruiting NCT04587219 - The Study of "Gam-COVID-Vac" Vaccine Against COVID-19 With the Participation of Volunteers of 60 y.o and Older Phase 2
Withdrawn NCT05430958 - Safety, Tolerability and Immunogenicity of INO-4800 for COVID19 in Healthy Volunteers Phase 1
Completed NCT04596579 - SARS-CoV-2 (COVID-19) Immune Surveillance Among a Population Based Sample of Adults in Florida
Completed NCT04405934 - COG-UK Project Hospital-Onset COVID-19 Infections Study N/A
Enrolling by invitation NCT04484025 - SPI-1005 Treatment in Moderate COVID-19 Patients Phase 2
Terminated NCT04442230 - NasoVAX in Patients With Early Coronavirus Infectious Disease 2019 (COVID-19) Phase 2
Terminated NCT04642638 - Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure Phase 2/Phase 3