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CompletedNCT04906629Boost-EBOVUpdated May 24, 2022

INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees

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

From the registry’s dates

  • Primary completion was Jan 2022, 4 years 9 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ebola Virus Disease
03

In context

Virus Diseases

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 →

Lead sponsor

University of Geneva, Switzerland is the lead sponsor of 43 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    INO-4201

    One intradermal injection of INO-4201 followed by electroporation

    Biological: INO-4201

  • Placebo comparator
    Placebo

    One intradermal injection of normal saline followed by electroporation

    Biological: Placebo

Interventions

  • BiologicalINO-4201

    One dose of 1 mg of INO-4201 in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000

  • BiologicalPlacebo

    One dose of normal saline in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000

06

What researchers measure

Primary outcomes

  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.

    Primary safety outcome

    Time frame: Days 0 - 14

  2. 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

Secondary outcomes

  1. Occurrence of solicited local and systemic reactogenicity signs and symptoms

    Secondary safety outcome

    Time frame: Days 0 - 14

  2. Occurrence of unsolicited adverse events

    Secondary safety outcome

    Time frame: Days 0 - 28

  3. Occurrence of serious adverse events (SAE)

    Secondary safety outcome

    Time frame: Days 0 - 168

  4. GMTs of EBOV-GP-binding antibodies as measured by ELISA

    Secondary immunogenicity outcome

    Time frame: Weeks 2, 12, 24

  5. GMTs of neutralizing antibodies

    Secondary immunogenicity outcome

    Time frame: Weeks 2, 4, 12, 24

07

Study locations

1 site
  • Geneva University Hospitals
    Geneva, 1205, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04906629
Lead sponsor
University of Geneva, Switzerland
Collaborators
Defense Advanced Research Projects Agency, Global Urgent and Advanced Research and Development (GuardRX), Inovio Pharmaceuticals
Responsible party
Angela HUTTNER (Principal Investigator, University of Geneva, Switzerland) — Principal investigator
First posted
May 28, 2021
Start date
Sep 1, 2021
Primary completion
Jan 5, 2022
Completion
May 11, 2022
Last update
May 24, 2022

Study contacts

Angela Huttner, MD
principal investigator · University of Geneva

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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