NA (Healthy Volunteers) Healthy Coronavirus
Conditions
Interventions
-In Part 1, approximately 192 participants ages 18-50 years will be assessed through five (5) dose levels and regimens. These five (5) dose
levels and regimens will be evaluated across nine (9) groups
Experimental: Part 1: INO-4700 Group A Participants will receive one ID injection of 0.6 milligram (mg) of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4
Experimental: Part 1: INO-4700 Group B Participants will receive one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4.
Experimental: Part 1: INO-4700 Group C Participants will receive one ID injection of 1.0 mg of INO-4700 followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
Experimental: Part 1: INO-4700 Group D Participants will receive two ID injections (in an acceptable location on two different limbs) of 0.5 mg each of INO-4700 followed by EP using the CELLECTRA™ 200
Experimental: Part 1: INO-4700 Group E Participants will receive two ID injections (in an acceptable location on two different limbs) of 1.0 mg each of INO-4700 followed by EP using the CELLECTRA™ 200
Placebo Comparator: Part 1: Placebo Group F Participants will receive one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4
Placebo Comparator: Part 1: Placebo Group G Participants will receive one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8.
Placebo Comparator: Part 1: Placebo Group H Participants will receive two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on
Placebo Comparator: Part 1: Placebo Group I Participants will receive two ID injections (in an acceptable location on two different limbs) of placebo followed by EP using the CELLECTRA™ 2000 device on
Experimental: Part 2: Parts 2A and 2B Participants will receive ID injection of INO-4700 based on optimal dose and regimen selection in Part 1 followed by EP using the CELLECTRA™ 2000 device on Day 0,
Drug: INO-4700 INO-4700 will be administered ID. Device: CELLECTRA™ 2000 EP using the CELLECTRA™ 2000 device will be administered following ID drug administration
Drug: Placebo Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID. Other Names: • SSC-0001 Device: CELLECTRA™ 2000 EP using the CELLECTRA™ 2000 device will be administered fo
Sponsors
Inovio Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: 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
| Measure | Time frame |
|---|---|
| Name: NA;Timepoints: NA;Measure: NA | — |
Countries
Jordan, Kenya, Lebanon, Saudi Arabia
Contacts
Public ContactAziz Zoghbi
Director of Country Oversight and Management Africa, Levant and GCC
Outcome results
None listed