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

• Status: Completed
• Trial end date: 2020-10-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Inovio Pharmaceuticals
• Collaborators: Coalition for Epidemic Preparedness Innovations; Coalition for Epidemic Preparedness Innovations (CEPI)

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.