Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
- Conditions
- Healthy Volunteers - MERS COV Vaccine
- Registration Number
- PACTR202012691703415
- Lead Sponsor
- Inovio Pharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 542
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 1 month following last dose.
Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 1 month 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 an investigational vaccine product for the prevention of MERS or severe acute respiratory syndrome (SARS);
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method