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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
60
INO-4500 will be administered ID on Day 0 and Week 4.
Placebo will be administered ID on Day 0 and Week 4.
EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
The Center for Pharmaceutical Research
Kansas City, Missouri, United States
Percentage of Participants with Adverse Events (AEs)
Time frame: Baseline up to Week 48
Percentage of Participants with Injection Site Reactions
Time frame: Day 0 up to Week 48
Incidence of adverse events of special interest
Time frame: Baseline up to Week 48
Change from Baseline in Antigen Specific Binding Antibody titers
Time frame: Day 0 up to Week 48
Change from Baseline in Lassa virus (LASV) Neutralizing Antibodies
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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