Ebola Virus Vaccine
ZEBOVAC : Phase II study among healthcare and frontline workers in Uganda of a new vaccine for Ebola and Marburg
The study, "An open-label, single arm study to provide additional information on immunogenicity and safety of Ad26.ZEBOV/MVA-BN®-Filo" was an interventional, single arm, open-label, non-randomized, phase II study to gather additional data on immunogenicity and safety of the Ad26.ZEBOV boosted with MVA-BN®-Filo vaccine against Ebola virus disease. The primary objective was to assess the humoral immune responses as measured by enzyme-linked immunosorbent assay (ELISA) to the Ebola glycoprotein after intramuscular administration of the vaccine in all participants. Safety, serious adverse event reporting and follow-up on outcomes of pregnancy, was the second primary objectives of this study.
Country
Uganda
Status
Terminated. Pending publication of results.
Our Role
Scientific Oversight, Study Site
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TUJIOKOWE
The purpose of this study, "evaluation of the field efficacy and safety of a two-dose heterologous Ebola prophylaxis vaccine in the Democratic Republic of Congo", is to vaccinate with one of the candidate vaccines, VAC52150 (Ad26. ZEBOV, MVA-BN®-Filo), in order to determine the field efficacy of the vaccine regimen to prevent EVD through a case-control (test-negative) study and to document the activities related to the implementation of a two-dose regimen in this setting. This study is an open, nonrandomized study of the Ad26.ZEBOV/MVA-BN-Filo vaccine regimen in a population of eligible adults and children. The objective is to estimate the field efficacy of vaccination of the population with the Ad26.ZEBOV / MVA-BN-Filo vaccination regimen for the prevention of EVD in adults and children at least 1 year of age.
Country
Democratic Republic of Congo
Status
Terminated. Pending publication of results.
Our Role
Scientific Oversight, Data, Management, Monitoring and Pharmacovigilance, Capacity Building
