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.
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
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.
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