Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4700 for Middle East Respiratory Syndrome Coronavirus (MERS-CoV) in Healthy Volunteers

Conditions
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Middle East Respiratory Syndrome Coronavirus (MERS-CoV)

Intervention / Treatment
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* Drug: INO-4700
* Drug: Placebo
* Device: CELLECTRA™ 2000


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1: INO-4700 Group A<br>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<br>* INO-4700 will be administered ID.<br>Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration<br>|
| Experimental: Part 1: INO-4700 Group B<br>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<br>* INO-4700 will be administered ID.<br>Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration<br>|
| Experimental: Part 1: INO-4700 Group C<br>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<br>* INO-4700 will be administered ID.<br>Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration<br>|
| Experimental: Part 1: INO-4700 Group D<br>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<br>* INO-4700 will be administered ID.<br>Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration<br>|
| Experimental: Part 1: INO-4700 Group E<br>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<br>* INO-4700 will be administered ID.<br>Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration<br>|
| Placebo Comparator: Part 1: Placebo Group F<br>Participants will receive one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 4. | Drug: Placebo<br>* Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.<br>* Other names: SSC-0001;Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration<br>|
| Placebo Comparator: Part 1: Placebo Group G<br>Participants will receive one ID injection of placebo followed by EP using the CELLECTRA™ 2000 device on Day 0 and Week 8. | Drug: Placebo<br>* Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.<br>* Other names: SSC-0001;Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration<br>|
| Placebo Comparator: Part 1: Placebo Group H<br>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<br>* Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.<br>* Other names: SSC-0001;Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration<br>|
| Placebo Comparator: Part 1: Placebo Group I<br>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<br>* Sterile saline sodium citrate (SSC) buffer (SSC-0001) will be administered ID.<br>* Other names: SSC-0001;Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration<br>|
| Experimental: Part 2: Parts 2A and 2B<br>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<br>* INO-4700 will be administered ID.<br>Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Healthy, Coronavirus