Official Title
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
Brief Summary

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.

Completed
Coronavirus Infection

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.

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Central Kentucky Research Associates
Lexington, Kentucky, United States

Center for Pharmaceutical Research
Kansas City, Missouri, United States

University of Pennsylvania
Philadelphia, Pennsylvania, United States

Dr. Ning Jiang, MD PhD, Study Director
Inovio Pharmaceuticals

Coalition for Epidemic Preparedness Innovations
NCT Number
Keywords
DNA vaccine
Electroporation
MeSH Terms
Coronavirus Infections