A Phase 1 interventional study of INO-4201 and Placebo in Ebola Virus Disease, sponsored by University of Geneva, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-24.
Sponsored by University of Geneva, Switzerland · Phase 1, Interventional, and Prevention
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.
914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.
This study's enrollment of 46 is below the median of 102 across 604 interventional studies indexed under Virus Diseases.
Browse Virus Diseases studies →University of Geneva, Switzerland is the lead sponsor of 43 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Temporary exclusion criteria:
One intradermal injection of INO-4201 followed by electroporation
Biological: INO-4201
One intradermal injection of normal saline followed by electroporation
Biological: Placebo
One dose of 1 mg of INO-4201 in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000
One dose of normal saline in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000
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
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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University of Geneva, Switzerland