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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Coronavirus Infection

Intervention / Treatment
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* Drug: INO-4800
* Device: CELLECTRA® 2000


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: INO-4800<br>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<br>* INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.<br>Device: CELLECTRA® 2000<br>* 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.<br>|
| Experimental: Group 2: INO-4800<br>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<br>* INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.<br>Device: CELLECTRA® 2000<br>* 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.<br>|
| Experimental: Group 3: INO-4800<br>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<br>* INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.<br>Device: CELLECTRA® 2000<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DNA vaccine, Electroporation