Status:
COMPLETED
INO-4201 as Booster in Healthy VSV-ZEBOV Vaccinees
Lead Sponsor:
University of Geneva, Switzerland
Collaborating Sponsors:
Defense Advanced Research Projects Agency
Global Urgent and Advanced Research and Development (GuardRX)
Conditions:
Ebola Virus Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 pre...
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 recei...
Eligibility Criteria
Inclusion
- Has provided written informed consent prior to screening
- Males and females ≥ 18 years old
- 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
- 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.
Exclusion
- 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.
- Temporary exclusion criteria:
- 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
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04906629
Start Date
September 1 2021
End Date
May 11 2022
Last Update
May 24 2022
Active Locations (1)
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1
Geneva University Hospitals
Geneva, Switzerland, 1205