INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees (Boost-EBOV)
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|ClinicalTrials.gov Identifier: NCT04906629|
Recruitment Status : Completed
First Posted : May 28, 2021
Last Update Posted : May 24, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Ebola Virus Disease||Biological: INO-4201 Biological: Placebo||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase Ib, Placebo-controlled Randomized Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of INO-4201 Followed by Electroporation as a Booster Vaccination in Healthy Volunteers Who Have Previously Received the VSV-ZEBOV Vaccine|
|Actual Study Start Date :||September 1, 2021|
|Actual Primary Completion Date :||January 5, 2022|
|Actual Study Completion Date :||May 11, 2022|
One intradermal injection of INO-4201 followed by electroporation
One dose of 1 mg of INO-4201 in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000
Placebo Comparator: Placebo
One intradermal injection of normal saline followed by electroporation
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. [ Time Frame: Days 0 - 14 ]Primary safety outcome
- Quantitative EBOV-GP-binding IgG antibody responses (GMTs as measured by ELISA) at 4 weeks after injection [ Time Frame: Days 0 - 28 ]Primary immunogenicity outcome
- Occurrence of solicited local and systemic reactogenicity signs and symptoms [ Time Frame: Days 0 - 14 ]Secondary safety outcome
- Occurrence of unsolicited adverse events [ Time Frame: Days 0 - 28 ]Secondary safety outcome
- Occurrence of serious adverse events (SAE) [ Time Frame: Days 0 - 168 ]Secondary safety outcome
- GMTs of EBOV-GP-binding antibodies as measured by ELISA [ Time Frame: Weeks 2, 12, 24 ]Secondary immunogenicity outcome
- GMTs of neutralizing antibodies [ Time Frame: Weeks 2, 4, 12, 24 ]Secondary immunogenicity outcome
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04906629
|Geneva University Hospitals|
|Geneva, Switzerland, 1205|
|Principal Investigator:||Angela Huttner, MD||University of Geneva|