Status:
COMPLETED
Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana
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, blinded, placebo-controlled trial to evaluate the safety, tolerability and immunological profile of INO-4500 administered by intradermal (ID) injection followed by electroporatio...
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);
- 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
- 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 greater than 30 dB 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.
Key Trial Info
Start Date :
January 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2022
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT04093076
Start Date
January 27 2021
End Date
October 14 2022
Last Update
November 21 2022
Active Locations (1)
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1
Noguchi Memorial Institute for Medical Research, University of Ghana
Legon, Accra, Ghana