Official Title
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
Brief Summary

The purpose of this Phase 2a, randomized, blinded, placebo-controlled, multi-center study is to evaluate the safety, tolerability and immunogenicity of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRA™ 2000 device in healthy adult volunteers for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) infection. This study is divided into 2 parts: Part 1- dose finding stage and Part 2- dose expansion stage.

Completed
Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Drug: INO-4700

INO-4700 will be administered ID.

Drug: Placebo

Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.
Other Name: SSC-0001

Device: CELLECTRA™ 2000

EP using the CELLECTRA™ 2000 device will be administered following ID drug administration

Eligibility Criteria

Key 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;

- Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human
Immunodeficiency Virus (HIV) antibody;

- Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically
significant findings (e.g. Wolff-Parkinson-White syndrome);

- Be post-menopausal or be surgically sterile or have a partner who is sterile or use
medically effective contraception with a failure rate of < 1% per year when used
consistently and correctly from screening until 3 months following last dose.

Key Exclusion Criteria:

- Pregnant or breastfeeding, or intending to become pregnant or father children within
the projected duration of the trial starting with the screening visit until 3 months
following last dose;

- History of respiratory diseases such as asthma, chronic obstructive pulmonary disease
(COPD) or chronic bronchitis;

- Currently participating in or has participated in a study with an investigational
product within 30 days preceding Day 0;

- Previous receipt of any vaccine within 30 days preceding Day 0 or planning to receive
any vaccine during the timeframe restricted per the protocol;

- Previous receipt of an investigational vaccine product for the prevention of MERS;

- Prior exposure to MERS-CoV or camels;

- Participants who participate in MERS-201 Part 1 cannot participate in MERS-201 Part 2;

- Fewer than two acceptable sites available for ID injection and EP considering the
deltoid and anterolateral quadriceps muscles;

- Prisoner or participants who are compulsorily detained (involuntary incarceration);

- Current or anticipated concomitant immunosuppressive therapy (excluding inhaled,
topical skin and/or eye drop-containing corticosteroids) prior to dosing. Systemic
corticosteroids must be discontinued at least 3 months prior to first dose;

- Reported active drug or alcohol or substance abuse or dependence.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Jordan
Kenya
Lebanon
Locations

Clinical Research Center, Irbid Specialty Hospital (CRC/ISH)
Irbid, Jordan

Pharmaceutical Research Center / Jordan University of Science and Technology
Irbid, Jordan

Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP)
Kericho, Kenya

Ahero Clincal Trials Unit
Kisumu, Kenya

American University of Beirut Medical Center
Beirut, Lebanon

Hammoud Hospital University Medical Center
Saida, Lebanon

Bonaventure Orizu, MD, Study Director
Inovio Pharmaceuticals

Coalition for Epidemic Preparedness Innovations
NCT Number
Keywords
Healthy
Coronavirus
MeSH Terms
Coronavirus Infections
Syndrome