INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees

NCT04906629 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 2020-02774
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Ebola Virus Disease

Outcome Measures

Primary Outcomes (2)

• 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

  Days 0 - 14

• Quantitative EBOV-GP-binding IgG antibody responses (GMTs as measured by ELISA) at 4 weeks after injection

  Primary immunogenicity outcome

  Days 0 - 28

Secondary Outcomes (5)

• Occurrence of solicited local and systemic reactogenicity signs and symptoms

  Days 0 - 14

• Occurrence of unsolicited adverse events

  Days 0 - 28

• Occurrence of serious adverse events (SAE)

  Days 0 - 168

• GMTs of EBOV-GP-binding antibodies as measured by ELISA

  Weeks 2, 12, 24

• GMTs of neutralizing antibodies

  Weeks 2, 4, 12, 24

Study Arms (2)

INO-4201

EXPERIMENTAL

One intradermal injection of INO-4201 followed by electroporation

Biological: INO-4201

Placebo

PLACEBO COMPARATOR

One intradermal injection of normal saline followed by electroporation

Biological: Placebo

Interventions

INO-4201 BIOLOGICAL

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

INO-4201

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has provided written informed consent prior to screening
• Males and females ≥ 18 years old
• Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening
• Has an acceptable site for ID electroporation considering the deltoid and anterolateral quadriceps muscles
• 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.

You may not qualify if:

• Female volunteers who are pregnant or breastfeeding at screening or prior to dosing
• Administration of an investigational compound either currently or within 30 days of Day 0
• Prisoner or volunteers who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness
• Active drug or alcohol or substance abuse or dependence
• Planned administration of another Ebola vaccine (including rVSV-ZEBOV and Ad26/MVA-BN-Filo vaccines) during the study period
• Administration of a live vaccine in the 21 days or an inactivated vaccine in the 14 days before planned injection
• 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.
• Acute disease at the time of randomization
• Active skin lesions at the potential injection site
• Temperature ≥38.0°C at the time of randomization
• Recent receipt of a SARS-CoV-2 vaccine with final dose \<4 weeks prior

Sponsors & Collaborators

• University of Geneva, Switzerland: lead
• Defense Advanced Research Projects Agency: collaborator
• Global Urgent and Advanced Research and Development (GuardRX): collaborator
• Inovio Pharmaceuticals: collaborator

Study Sites (1)

Geneva University Hospitals

Geneva, 1205, Switzerland

Location

Related Publications (1)

• Huttner A, Vega MA, Boehm-Bosmani C, Boyer J, Eberhardt C, Fontannaz P, Gillespie E, Lemeille S, Morrow MP, Nepveu-Traversy ME, Orizu B, Reuschel EL, Roth R, Sharkhith H, Sylvester AJ, Vetter P, Humeau LM, Pignac-Kobinger J, Liebowitz D, Didierlaurent AM, Siegrist CA, Kobinger GP. A Phase Ib, Placebo-controlled Randomized Clinical Trial of the Ebolavirus DNA Vaccine Candidate INO-4201 Followed by Electroporation as Booster Vaccination in Healthy, rVSVDeltaG-ZEBOV-GP-primed Volunteers (Boost-EBOV). Clin Microbiol Infect. 2026 Jan 27:S1198-743X(26)00024-8. doi: 10.1016/j.cmi.2026.01.019. Online ahead of print.

  PMID: 41610955 DERIVED

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, Viral; RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Officials

• Angela Huttner, MD

  University of Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: September 1, 2021
• Primary Completion: January 5, 2022
• Study Completion: May 11, 2022
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

CH (1)