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

Inovio Pharmaceuticals0 个研究点目标入组 220 人开始时间: 2019年9月6日最近更新: 2023年5月29日

研究概览

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•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.

•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 30dB or greater for any frequency tested between 500 Hz - 8000Hz;
•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 PI feels is contraindicated to clinical trial participation.

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