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INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees

NCT04906629 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2022-05-24

No results posted yet for this 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.

Conditions

  • Ebola Virus Disease

Interventions

BIOLOGICAL

INO-4201

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Defense Advanced Research Projects Agency

    collaborator FED

  • Global Urgent and Advanced Research and Development (GuardRX)

    collaborator UNKNOWN

  • Inovio Pharmaceuticals

    collaborator INDUSTRY

  • University of Geneva, Switzerland

    lead OTHER

Principal Investigators

  • Angela Huttner, MD · University of Geneva

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-01-05
Completion
2022-05-11
FDA Drug
Yes

Countries

  • Switzerland

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04906629 on ClinicalTrials.gov