Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana

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

Official Title
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Dose-Ranging Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Combination With Electroporation in Healthy Volunteers in Ghana

Conditions
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Lassa Fever

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


Participation Criteria
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Eligibility Criteria
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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); Must meet one of the following criteria with respect to reproductive capacity: Surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). In the case of vasectomy, participants should wait six (6) months post-vasectomy prior to enrolling. Women who are post-menopausal as defined by absence of menstruation for ≥ 12 months. Use of medically effective contraception when used consistently and correctly from Screening until three (3) months following last dose. 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 three (3) months following last dose; Positive serum pregnancy test during Screening or positive urine pregnancy test prior to any dosing; 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; Audiometry testing that demonstrates a hearing level threshold greater than 30 dB for any frequency tested between 500 Hz - 8000 Hz; Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles; Current or anticipated concomitant immunosuppressive therapy; Fever with or without cough or any other concurrent illness which the principal investigator feels is contraindicated to clinical trial participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: 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>|
| 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 in two acceptable locations in two different limbs at each dosing visit. | 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 Group C<br>Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device. | Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.<br>Drug: Placebo<br>* Placebo will be administered ID on Day 0 and Week 4.<br>* Other names: SSC-0001;|
| Placebo Comparator: Placebo Group D<br>Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device in two acceptable locations in two different limbs at each dosing visit.. | Device: CELLECTRA™ 2000<br>* EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.<br>Drug: Placebo<br>* Placebo will be administered ID on Day 0 and Week 4.<br>* Other names: SSC-0001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events (AEs) |  | Baseline up to Week 48 | 
| Number of Participants with Injection Site Reactions |  | Day 0 up to Week 48 | 
| Number of Participants with Adverse Events of Special Interest (AESIs) |  | Baseline up to Week 48 | 
| Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies |  | Day 0 up to Week 48 | 
| Change from Baseline in Lassa virus (LASV) Neutralization Assays |  | 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
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Keywords Provided by Centre Hospitalier Valida
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Healthy volunteer