Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers
- Conditions
- A (Healthy Volunteers)Healthy CoronavirusY59.9
- Registration Number
- LBCTR2020113522
- Lead Sponsor
- Inovio Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 542
a. Able to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures;
b. For Part 1, adults age 18 and 50 years, inclusive. For Part 2, adults at least 18 years of age;
c. Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening. Note: Participants taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose, as defined by non-change in dose for the 3 months prior to the first dose of study medication and no planned changes during the active dosing period of the study;
d. Able and willing to comply with all study procedures;
e. Screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the Investigator;
f. Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody or rapid test at screening;
g. Screening ECG deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
h. Must meet one of the following criteria with respect to reproductive capacity:
? Women who are post-menopausal as defined by spontaneous amenorrhea for = 12 months;
? Surgically sterile or have a partner who is sterile (i.e., vasectomy in males at least six (6) months prior to enrollment or tubal ligation, absence of ovaries and/or uterus in females);
? 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.
a.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;
b.Positive serum pregnancy test during screening or positive urine pregnancy test prior to dosing;
c.History of respiratory diseases such as asthma, chronic obstructive pulmonary disease or chronic bronchitis;
d.Is currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
e.Previous receipt of any vaccine within 30 days preceding Day 0 or planning to receive any vaccine during the timeframe restricted per the protocol;
f.Previous receipt of an investigational vaccine product for prevention of MERS;
g.Prior exposure to MERS-CoV or camels (serology or antibody testing will be requested at the Investigator’s discretion);
h.Participants who participated in MERS-201 Part 1 cannot participate in MERS-201 Part 2;
i.Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles. The following are unacceptable sites:
a.Tattoos, keloids or hypertrophic scars located within 2 cm of intended administration site;
b.Implantable-Cardioverter-defibrillator (ICD) or pacemaker (to prevent a lifethreatening arrhythmia) that is located ipsilateral to the deltoid injection site (unless deemed acceptable by a cardiologist);
c.Any metal implants or implantable medical device within the electroporation site;
j.Prisoner or participants who are compulsorily detained (involuntary incarceration);
k.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;
l.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 ame: Tolerability and safety of INO-4700 administered by ID injection;Timepoints: Duration of both parts 1 (up to week 48) and part 2 (up to week 68) of the study;Measure: Incidence of Adverse Events, Number and severity of injection site reactions, Incidence of Adverse Events of Special Interest;Name: Cellular (T Cell) and Humoral immune response to INO-4700 administered by ID injection to select the optimal dose and regimen;Timepoints: Part 1: Week 10;Measure: MERS-CoV antigen specific antibodies, Antigen specific cytokine producing T cell responses;Name: Safety and immunogenicity of selected optimal dose;Timepoints: Part 2: up to week 68;Measure: MERS-CoV antigen specific antibodies, Antigen specific cytokine producing T cell responses, Incidence of Adverse Events, Number and severity of injection site reactions, Incidence of Adverse Events of Special Interest
- Secondary Outcome Measures
Name Time Method ame: NA;Timepoints: NA;Measure: NA