Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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
|
| 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. |
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
|
| 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. |
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
|
| 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™ 2000 device on Day 0 and Week 8. |
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
|
| 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™ 2000 device on Day 0 and Week 4. |
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
|
| 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. |
Drug: Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.
Other Names:
Device: CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration
|
| 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. |
Drug: Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.
Other Names:
Device: CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration
|
| 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 Day 0 and Week 8. |
Drug: Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.
Other Names:
Device: CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration
|
| 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 Day 0 and Week 4. |
Drug: Placebo
Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.
Other Names:
Device: CELLECTRA™ 2000
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration
|
| 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, Week 4 or Week 8 and a booster dose at Week 48 (only for Part 2B participants receiving a third dose). |
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
|
Outcome Measures
Primary Outcome Measures
- Frequency of Adverse Events in Part 1 [Part 1: baseline up to Week 48]
- Percentage of Participants with Adverse Events in Part 1 [Part 1: baseline up to Week 48]
- Frequency of Injection Site Reactions in Part 1 [Part 1: baseline up to Week 48]
- Percentage of Participants with Injection Site Reactions in Part 1 [Part 1: baseline up to Week 48]
- Frequency of Adverse Events of Special Interest (AESIs) in Part 1 [Part 1: baseline up to Week 48]
- Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 1 [Part 1: baseline up to Week 48]
- Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 1 [Part 1: baseline up to Week 48]
- Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 1 [Part 1: baseline up to Week 48]
- Percentage Antigen Specific Cellular Immune Response in Part 1 [Part 1: baseline up to Week 48]
- Percentage of Seroconverted Participants in Part 1 [Part 1: baseline up to Week 48]
- Percentage of Participants with Overall Immune Response in Part 1 [Part 1: baseline up to Week 48]
- Frequency of Adverse Events in Part 2 [Part 2: baseline up to Week 68]
- Percentage of Participants with Adverse Events in Part 2 [Part 2: baseline up to Week 68]
- Frequency of Injection Site Reactions in Part 2 [Part 2: baseline up to Week 68]
- Percentage of Participants with Injection Site Reactions in Part 2 [Part 2: baseline up to Week 68]
- Frequency of Adverse Events of Special Interest (AESIs) in Part 2 [Part 2: baseline up to Week 68]
- Percentage of Participants with Adverse Events of Special Interest (AESIs) in Part 2 [Part 2: baseline up to Week 68]
- Geometric Mean Titers (GMTs) of MERS-CoV Antigen Specific Binding Antibodies in Part 2 [Part 2: baseline up to Week 68]
- Percentage MERS-CoV Antigen Specific Neutralizing Antibodies in Part 2 [Part 2: baseline up to Week 68]
- Percentage Antigen Specific Cellular Immune Response in Part 2 [Part 2: baseline up to Week 68]
- Percentage of Seroconverted Participants in Part 2 [Part 2: baseline up to Week 68]
- Percentage of Participants with Overall Immune Response in Part 2 [Part 2: baseline up to Week 68]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Research Center, Irbid Specialty Hospital (CRC/ISH) | Irbid | Jordan | 21110 | |
| 2 | Pharmaceutical Research Center / Jordan University of Science and Technology | Irbid | Jordan | 22110 | |
| 3 | Kenya Medical Research Institute (KEMRI)/Walter Reed Project (WRP) | Kericho | Kenya | 20200 | |
| 4 | Ahero Clincal Trials Unit | Kisumu | Kenya | 40100 | |
| 5 | American University of Beirut Medical Center | Beirut | Lebanon | ||
| 6 | Hammoud Hospital University Medical Center | Saida | Lebanon |
Sponsors and Collaborators
- Inovio Pharmaceuticals
- Coalition for Epidemic Preparedness Innovations
Investigators
- Study Director: Bonaventure Orizu, MD, Inovio Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MERS-201