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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: March 2022

Interventions

  • Drug: INO-4500
    • INO-4500 will be administered ID on Day 0 and Week 4.
  • Device: CELLECTRA™ 2000
    • EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.
  • Drug: Placebo
    • Placebo will be administered ID on Day 0 and Week 4.

Arms, Groups and Cohorts

  • Experimental: INO-4500 Group A
    • Participants will receive 1 ID injection of 1 mg/dose INO-4500 followed by EP using the CELLECTRA™ 2000 device.
  • Experimental: INO-4500 Group B
    • 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.
  • Placebo Comparator: Placebo Group C
    • Participants will receive 1 ID injection of 1 mg/dose placebo followed by EP using the CELLECTRA™ 2000 device.
  • Placebo Comparator: Placebo Group D
    • 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..

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants with Adverse Events (AEs)
    • Time Frame: Baseline up to Week 48
  • Number of Participants with Injection Site Reactions
    • Time Frame: Day 0 up to Week 48
  • Number of Participants with Adverse Events of Special Interest (AESIs)
    • Time Frame: Baseline up to Week 48
  • Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies
    • Time Frame: Day 0 up to Week 48
  • Change from Baseline in Lassa virus (LASV) Neutralization Assays
    • Time Frame: Day 0 up to Week 48
  • Change from Baseline in Interferon-Gamma Response Magnitude
    • Time Frame: Day 0 up to Week 48

Participating in This Clinical Trial

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 one (1) month 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 1 month 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 of 30 dB or greater for any frequency tested between 250 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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Inovio Pharmaceuticals
  • Collaborator
    • Coalition for Epidemic Preparedness Innovations (CEPI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • ShuPing Yang, MD, Study Director, Inovio Pharmaceuticals
  • Overall Contact(s)
    • Inovio Call Center, +1 267-440-4237, clinical.trials@inovio.com

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