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

Overview

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.

Full Title of Study: “Study to Evaluate the Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Prevention
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: October 2020

Interventions

  • Drug: INO-4500
    • INO-4500 will be administered ID on Day 0 and Week 4.
  • Drug: Placebo
    • Placebo 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.

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
  • Placebo Comparator: Placebo Comparator Group A
    • Participants will receive 1 ID injection of 1 mg/dose placebo 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
  • Placebo Comparator: Placebo Comparator Group B
    • Participants will receive 2 ID injections of 1 mg/dose placebo followed by EP using the CELLECTRA® 2000 device

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants with Adverse Events (AEs)
    • Time Frame: Baseline up to Week 48
  • Percentage of Participants with Injection Site Reactions
    • Time Frame: Day 0 up to Week 48
  • Incidence of adverse events of special interest
    • Time Frame: Baseline up to Week 48

Secondary Measures

  • Change from Baseline in Antigen Specific Binding Antibody titers
    • Time Frame: Day 0 up to Week 48
  • Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies
    • 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);
  • 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.

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, PhD, Study Director, Inovio Pharmaceuticals

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.