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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
Sponsor:
Collaborators:
Defense Advanced Research Projects Agency
Global Urgent and Advanced Research and Development (GuardRX)
Inovio Pharmaceuticals
Information provided by (Responsible Party):
Angela HUTTNER, University of Geneva, Switzerland

Brief Summary:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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


Arm Intervention/treatment
Experimental: INO-4201
One intradermal injection of INO-4201 followed by electroporation
Biological: INO-4201
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
Biological: Placebo
One dose of normal saline in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Occurrence of solicited local and systemic reactogenicity signs and symptoms [ Time Frame: Days 0 - 14 ]
    Secondary safety outcome

  2. Occurrence of unsolicited adverse events [ Time Frame: Days 0 - 28 ]
    Secondary safety outcome

  3. Occurrence of serious adverse events (SAE) [ Time Frame: Days 0 - 168 ]
    Secondary safety outcome

  4. GMTs of EBOV-GP-binding antibodies as measured by ELISA [ Time Frame: Weeks 2, 12, 24 ]
    Secondary immunogenicity outcome

  5. GMTs of neutralizing antibodies [ Time Frame: Weeks 2, 4, 12, 24 ]
    Secondary immunogenicity outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Has provided written informed consent prior to screening
  2. Males and females ≥ 18 years old
  3. Previously vaccinated with a single dose of VSV-ZEBOV at any dose between 10^5 and 10^8 pfu more than 6 months prior to inclusion
  4. Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening
  5. Has an acceptable site for ID electroporation considering the deltoid and anterolateral quadriceps muscles
  6. Is post-menopausal, or surgically sterile, or has a partner who is sterile, or uses a medically effective contraception with a failure rate of <1% per year when used consistently and correctly from screening until 6 months following last dose.

Exclusion Criteria:

  1. Female volunteers who are pregnant or breastfeeding at screening or prior to dosing
  2. Administration of an investigational compound either currently or within 30 days of Day 0
  3. Prisoner or volunteers who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness
  4. Active drug or alcohol or substance abuse or dependence
  5. Planned administration of another Ebola vaccine (including rVSV-ZEBOV and Ad26/MVA-BN-Filo vaccines) during the study period
  6. Administration of a live vaccine in the 21 days or an inactivated vaccine in the 14 days before planned injection
  7. Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, or low-dose methotrexate). Systemic corticosteroids must be discontinued at least 4 weeks prior to first dose.

Temporary exclusion criteria:

  1. Acute disease at the time of randomization
  2. Active skin lesions at the potential injection site
  3. Temperature ≥38.0°C at the time of randomization
  4. Recent receipt of a SARS-CoV-2 vaccine with final dose <4 weeks prior

Information from the National Library of Medicine

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


Locations
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Switzerland
Geneva University Hospitals
Geneva, Switzerland, 1205
Sponsors and Collaborators
University of Geneva, Switzerland
Defense Advanced Research Projects Agency
Global Urgent and Advanced Research and Development (GuardRX)
Inovio Pharmaceuticals
Investigators
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Principal Investigator: Angela Huttner, MD University of Geneva
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Responsible Party: Angela HUTTNER, Principal Investigator, University of Geneva, Switzerland
ClinicalTrials.gov Identifier: NCT04906629    
Other Study ID Numbers: 2020-02774
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: May 24, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Virus Diseases
Hemorrhagic Fever, Ebola
Infections
Hemorrhagic Fevers, Viral
RNA Virus Infections
Filoviridae Infections
Mononegavirales Infections