Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Lassa Fever
In brief
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.
Key facts
- Study ID
- NCT03805984
- Run by
- Inovio Pharmaceuticals
- People needed
- 60
- Starts
- 2019-05-09
- Expected to finish
- 2020-10-21
- Last updated by the study team
- 2020-11-23
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The Center for Pharmaceutical Research — Kansas City, Missouri, United States
Full record on ClinicalTrials.gov
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