Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers

Phase 1 Open-label Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4800, a Prophylactic Vaccine Against SARS-CoV-2, Administered Intradermally Followed by Electroporation in Healthy Volunteers

This is an open-label trial to evaluate the safety, tolerability and immunological profile of INO-4800 administered by intradermal (ID) injection followed by electroporation (EP) using CELLECTRA® 2000 device in healthy adult volunteers.

Study Overview

• Status: Completed
• Conditions: Coronavirus Infection
• Intervention / Treatment: Drug: INO-4800; Device: CELLECTRA® 2000

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Central Kentucky Research Associates
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Center For Pharmaceutical Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at screening.
• Able and willing to comply with all study procedures.
• Screening laboratory results within normal limits or deemed not clinically significant by the Investigator.
• Body Mass Index of 18-30 kg/m^2, inclusive, at screening.
• Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody at screening.
• Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome).
• Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 3 months following last dose, be post-menopausal, be surgically sterile or have a partner who is sterile.

Exclusion Criteria:

• Pregnant or breastfeeding or intending to become pregnant or father children within the projected duration of the trial from screening until 3 months following last dose.
• Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0.
• Previous exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or receipt of an investigational product for the prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or severe acute respiratory syndrome (SARS).
• In a current occupation with high risk of exposure to SARS-CoV-2 (e.g., health care workers or emergency response personnel having direct interactions with or providing direct care to patients).

• Current or history of the following medical conditions:

  • Respiratory diseases
  • Hypersensitivity or severe allergic reactions to vaccines or drugs
  • Diagnosis of diabetes mellitus
  • Hypertension
  • Malignancy within 5 years of screening
  • Cardiovascular diseases

• Immunosuppression as a result of underlying illness or treatment including:

  • Primary immunodeficiencies
  • Long term use (≥7 days) of oral or parenteral glucocorticoids
  • Current or anticipated use of disease-modifying doses of anti-rheumatic drugs and biologic disease-modifying drugs
  • History of solid organ or bone marrow transplantation
  • Prior history of other clinically significant immunosuppressive or clinically diagnosed autoimmune disease
• Fewer than two acceptable sites available for intradermal (ID) injection and electroporation (EP) considering the deltoid and anterolateral quadriceps muscles.
• Reported smoking, vaping, or active drug, alcohol or substance abuse or dependence.
• Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1: INO-4800; Participants will receive one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.	Drug: INO-4800; INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.; Device: CELLECTRA® 2000; EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.
Experimental: Group 2: INO-4800; 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 per dosing visit.	Drug: INO-4800; INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.; Device: CELLECTRA® 2000; EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.
Experimental: Group 3: INO-4800; Participants will receive one ID injection of 0.5 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit.	Drug: INO-4800; INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.; Device: CELLECTRA® 2000; EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with Adverse Events (AEs)	Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Percentage of Participants with Administration (Injection) Site Reactions	Day 0 up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Percentage of Participants with Adverse Events of Special Interest (AESIs)	Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Change from Baseline in SARS-CoV-2 Spike Glycoprotein Antigen-Specific Binding Antibody Titers	Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)
Change from Baseline in Antigen-Specific Cellular Immune Response	Baseline up to Week 52 (if not receiving an optional booster dose) or the 48 Week Post-Booster Dose Visit (if receiving an optional booster dose)

Collaborators and Investigators

• Sponsor: Inovio Pharmaceuticals
• Collaborators: Coalition for Epidemic Preparedness Innovations
• Investigators: Study Director: Dr. Ning Jiang, MD PhD, Inovio Pharmaceuticals

Publications and helpful links

General Publications

• Kraynyak KA, Blackwood E, Agnes J, Tebas P, Giffear M, Amante D, Reuschel EL, Purwar M, Christensen-Quick A, Liu N, Andrade VM, Diehl MC, Wani S, Lupicka M, Sylvester A, Morrow MP, Pezzoli P, McMullan T, Kulkarni AJ, Zaidi FI, Frase D, Liaw K, Smith TRF, Ramos SJ, Ervin J, Adams M, Lee J, Dallas M, Shah Brown A, Shea JE, Kim JJ, Weiner DB, Broderick KE, Humeau LM, Boyer JD, Mammen MP. SARS-CoV-2 DNA Vaccine INO-4800 Induces Durable Immune Responses Capable of Being Boosted in a Phase 1 Open-Label Trial. J Infect Dis. 2022 Jun 1;225(11):1923-1932. doi: 10.1093/infdis/jiac016.
• Tebas P, Yang S, Boyer JD, Reuschel EL, Patel A, Christensen-Quick A, Andrade VM, Morrow MP, Kraynyak K, Agnes J, Purwar M, Sylvester A, Pawlicki J, Gillespie E, Maricic I, Zaidi FI, Kim KY, Dia Y, Frase D, Pezzoli P, Schultheis K, Smith TRF, Ramos SJ, McMullan T, Buttigieg K, Carroll MW, Ervin J, Diehl MC, Blackwood E, Mammen MP, Lee J, Dallas MJ, Brown AS, Shea JE, Kim JJ, Weiner DB, Broderick KE, Humeau LM. Safety and immunogenicity of INO-4800 DNA vaccine against SARS-CoV-2: A preliminary report of an open-label, Phase 1 clinical trial. EClinicalMedicine. 2021 Jan;31:100689. doi: 10.1016/j.eclinm.2020.100689. Epub 2020 Dec 24.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2020
• Primary Completion (Actual): February 10, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: April 3, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 7, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 13, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: DNA vaccine; Electroporation
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: COVID19-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data dictionaries and all collected IPD will be stripped of identifiers and may be made available upon request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes