Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers (NCT03805984) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
United States60 participantsStarted 2019-05-09
Plain-language 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.
Who can participate
Age range18 Years – 50 Years
SexALL
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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 immunosuppressiv…
What they're measuring
1
Percentage of Participants with Adverse Events (AEs)
Timeframe: Baseline up to Week 48
2
Percentage of Participants with Injection Site Reactions