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

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Inovio Pharmaceuticals
• Collaborator: Coalition for Epidemic Preparedness Innovations

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);

• 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 of 30 dB or greater 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.