Ebola virus disease (EVD) is a serious illness with a high fatality rate. Currently only one vaccine is available, VSV-ZEBOV/Ervebo; this vaccine is clinically effective and has been deployed as a preventive measure during recent Ebola outbreaks. The durability of protection afforded by this vaccine is unknown, however, and it is thought that a booster vaccination may be required to maintain immune responses. Recently, a synthetic DNA vaccine, INO-4201, was tested in humans and showed good immunogenicity and an enhanced safety profile. This study aims to test whether the DNA-based candidate INO-4201 can be used as a booster in healthy volunteers previously vaccinated with VSV-ZEBOV.
This randomized placebo-controlled phase 1b trial will evaluate the safety, tolerability and immunogenicity of the DNA-based vaccine candidate INO-4201 in healthy adult volunteers who previously received a single injection of VSV-ZEBOV. These participants will be randomized to either INO-4201 or placebo, injected once intradermally (ID) followed by electroporation (EP) with the CELLECTRA2000 device. Volunteers will be observed for 1 hour after vaccination and will attend follow-up visits at the Clinical Trials Unit in the 24 weeks after injection (8 visits in all). Primary outcome parameters are (i) the incidence of adverse events in relationship with INO-4201 from day 0 to 14, and (ii) geometric mean titers (GMT) of EBOV-GP-binding IgG antibodies at 4 weeks post-injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
46
Geneva University Hospitals
Geneva, Switzerland
Incidence of adverse events by systemic organ class, preferred term, severity and relationship to investigational product INO-4201 from day 0 to day 14.
Primary safety outcome
Time frame: Days 0 - 14
Quantitative EBOV-GP-binding IgG antibody responses (GMTs as measured by ELISA) at 4 weeks after injection
Primary immunogenicity outcome
Time frame: Days 0 - 28
Occurrence of solicited local and systemic reactogenicity signs and symptoms
Secondary safety outcome
Time frame: Days 0 - 14
Occurrence of unsolicited adverse events
Secondary safety outcome
Time frame: Days 0 - 28
Occurrence of serious adverse events (SAE)
Secondary safety outcome
Time frame: Days 0 - 168
GMTs of EBOV-GP-binding antibodies as measured by ELISA
Secondary immunogenicity outcome
Time frame: Weeks 2, 12, 24
GMTs of neutralizing antibodies
Secondary immunogenicity outcome
Time frame: Weeks 2, 4, 12, 24
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