Lassa Fever
Conditions
Keywords
Healthy volunteer
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 electroporation (EP) using CELLECTRA™ 2000 device in healthy volunteers in Ghana.
Interventions
DRUGINO-4500
INO-4500 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.
DRUGPlacebo
Placebo will be administered ID on Day 0 and Week 4.
Sponsors
Coalition for Epidemic Preparedness Innovations
Inovio Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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); * 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 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Adverse Events (AEs) | Baseline up to Week 48 |
| Number of Participants with Injection Site Reactions | Day 0 up to Week 48 |
| Number of Participants with Adverse Events of Special Interest (AESIs) | Baseline up to Week 48 |
| Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies | Day 0 up to Week 48 |
| Change from Baseline in Lassa virus (LASV) Neutralization Assays | Day 0 up to Week 48 |
| Change from Baseline in Interferon-Gamma Response Magnitude | Day 0 up to Week 48 |
Countries
Ghana
Outcome results
None listed