Lassa Fever
Conditions
Keywords
Healthy volunteer
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) injection followed by electroporation using the CELLECTRA® 2000 device in healthy adult volunteers.
Interventions
DRUGINO-4500
INO-4500 will be administered ID on Day 0 and Week 4.
DRUGPlacebo
Placebo will be administered ID on Day 0 and Week 4.
DEVICECELLECTRA® 2000
EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
Sponsors
Coalition for Epidemic Preparedness Innovations
Inovio Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The Sponsor will be blinded up to Week 6; at that time the Sponsor will become group-level unblinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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 immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants with Adverse Events (AEs) | Baseline up to Week 48 |
| Percentage of Participants with Injection Site Reactions | Day 0 up to Week 48 |
| Incidence of adverse events of special interest | Baseline up to Week 48 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Antigen Specific Binding Antibody titers | Day 0 up to Week 48 |
| Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies | Day 0 up to Week 48 |
| Change from Baseline in Interferon-Gamma Response Magnitude | Day 0 up to Week 48 |
Countries
United States
Outcome results
None listed