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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02267109
Other study ID # HP-00061513
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 2014
Est. completion date April 20, 2016

Study information

Verified date September 2019
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Ebola virus causes an infection known as Ebola virus disease (EVD). This is generally a severe disease which can also lead to death. The 2014 outbreak of EVD in West Africa is the largest ever. Researchers want to develop a vaccine to prevent Ebola infection. It is impossible for someone to get an Ebola infection from this vaccine.


Description:

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Study Design


Intervention

Biological:
Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z
IM injection of Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z):
Booster-MVA-BN® Filo or saline placebo
IM injection of Booster-MVA-BN® Filo or saline placebo

Locations

Country Name City State
Mali Center for Vaccine Development, Mali Bamako

Sponsors (4)

Lead Sponsor Collaborator
University of Maryland, Baltimore Leidos Biomedical Research, Inc., National Institute of Allergy and Infectious Diseases (NIAID), Wellcome Trust

Country where clinical trial is conducted

Mali, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of solicited local and systemic reactogenicity signs and symptoms Daily for 7 days following each vaccination.
Primary Occurrence of unsolicited adverse events 28 days following the vaccination
Primary Change from baseline for safety laboratory measures 6 months for each volunteer
Primary Occurrence of serious adverse events and incident chronic medical conditions 6 months for each volunteer
Secondary Antibody responses as measured by ELISA and neutralization assays Day 1, 7, 14, 28, 90 and 180 after vaccination
Secondary T cell immune responses as measured by intracellular cytokine staining assay Day 1, 7 and 14 after vaccination
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