Status:
COMPLETED
Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers
Lead Sponsor:
Inovio Pharmaceuticals
Collaborating Sponsors:
Coalition for Epidemic Preparedness Innovations
Conditions:
Lassa Fever
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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) injecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03805984
Start Date
May 9 2019
End Date
October 21 2020
Last Update
November 23 2020
Active Locations (1)
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1
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114