Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a randomized and double-blinded within study group, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers.

Official Title
-----------------
Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers

Conditions
-----------------
Lassa Fever

Intervention / Treatment
-----------------
* Drug: INO-4500
* Drug: Placebo
* Device: CELLECTRA® 2000


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening; 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); Use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 6 months following last dose or be post-menopausal or be surgically sterile or have a partner who is sterile. 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 1 month following last dose; Is 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 prevention of Lassa Fever; Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles; Audiometry testing that demonstrates a hearing level threshold of 30 dB or greater for any frequency tested between 250 Hz - 8000 Hz; Recent (within 6 months) or planned travel to Lassa-endemic region; Current or anticipated concomitant immunosuppressive therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INO-4500 Group A<br>Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device | Drug: INO-4500<br>* INO-4500 will be administered ID on Day 0 and Week 4.<br>Device: CELLECTRA® 2000<br>* EP using the CELLECTRA® 2000 device will be administered following ID drug administration.<br>|
| Placebo Comparator: Placebo Comparator Group A<br>Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device | Drug: Placebo<br>* Placebo will be administered ID on Day 0 and Week 4.<br>* Other names: SSC-0001;Device: CELLECTRA® 2000<br>* EP using the CELLECTRA® 2000 device will be administered following ID drug administration.<br>|
| Experimental: INO-4500 Group B<br>Participants will receive 2 ID injections of 1 mg/dose INO-4500 followed by EP using the CELLECTRA® 2000 device | Drug: INO-4500<br>* INO-4500 will be administered ID on Day 0 and Week 4.<br>Device: CELLECTRA® 2000<br>* EP using the CELLECTRA® 2000 device will be administered following ID drug administration.<br>|
| Placebo Comparator: Placebo Comparator Group B<br>Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device | Drug: Placebo<br>* Placebo will be administered ID on Day 0 and Week 4.<br>* Other names: SSC-0001;Device: CELLECTRA® 2000<br>* EP using the CELLECTRA® 2000 device will be administered following ID drug administration.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Adverse Events (AEs) |  | Baseline up to Week 48 | 
| Percentage of Participants with Injection Site Reactions |  | Day 0 up to Week 48 | 
| Incidence of adverse events of special interest |  | Baseline up to Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Antigen Specific Binding Antibody titers |  | Day 0 up to Week 48 | 
| Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies |  | Day 0 up to Week 48 | 
| Change from Baseline in Interferon-Gamma Response Magnitude |  | Day 0 up to Week 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteer