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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
220
INO-4500 will be administered ID on Day 0 and Week 4.
EP using the CELLECTRA™ 2000 device will be administered following ID drug administration.
Placebo will be administered ID on Day 0 and Week 4.
Noguchi Memorial Institute for Medical Research, University of Ghana
Legon, Accra, Ghana
Number of Participants with Adverse Events (AEs)
Time frame: Baseline up to Week 48
Number of Participants with Injection Site Reactions
Time frame: Day 0 up to Week 48
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Baseline up to Week 48
Change from Baseline in Lassa Virus (LASV) Antigen Specific Binding Antibodies
Time frame: Day 0 up to Week 48
Change from Baseline in Lassa virus (LASV) Neutralization Assays
Time frame: Day 0 up to Week 48
Change from Baseline in Interferon-Gamma Response Magnitude
Time frame: Day 0 up to Week 48
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