biostudies-literatureWatson-Jones DHorizon 2020 Framework ProgrammeDepartment for International DevelopmentMedical Research CouncilCoalition for Epidemic Preparedness InnovationsWellcome TrustPaul G. Allen Family Foundatione055596https://www.ebi.ac.uk/biostudies/studies/S-EPMC8905941biostudies-literatureUnknown12(3)<h4>Introduction</h4>Ebola virus disease (EVD) continues to be a significant public health problem in sub-Saharan Africa, especially in the Democratic Republic of the Congo (DRC). Large-scale vaccination during outbreaks may reduce virus transmission. We established a large population-based clinical trial of a heterologous, two-dose prophylactic vaccine during an outbreak in eastern DRC to determine vaccine effectiveness.<h4>Methods and analysis</h4>This open-label, non-randomised, population-based trial enrolled eligible adults and children aged 1 year and above. Participants were offered the two-dose candidate EVD vaccine regimen VAC52150 (Ad26.ZEBOV, Modified Vaccinia Ankara (MVA)-BN-Filo), with the doses being given 56 days apart. After vaccination, serious adverse events (SAEs) were pBMJ openProtocol for a phase 3 trial to evaluate the effectiveness and safety of a heterologous, two-dose vaccine for Ebola virus disease in the Democratic Republic of the Congo.PMC8905941MR/R010161/1857935220506/Z/20/ZFELS1903Johnson JGrais RFLuhn KChoi EMLeyssen MRoberts CHBausch DGKavunga-Membo HHatchett RKighoma PMCamacho ALees SAhuka SManno DRattigan SDelaporte ESmith PGSaville MEdwards TMambula GBurton MJohn Edmunds WDRC-EB-001 protocol writing teamSpiessens BDouoguih MMuyembe JJVoss GGreenwood BLongini IMEdmunds WJRoberts NImbault NGrais RWatson-Jones DfalseProtocol for a phase 3 trial to evaluate the effectiveness and safety of a heterologous, two-dose vaccine for Ebola virus disease in the Democratic Republic of the Congo.<h4>Introduction</h4>Ebola virus disease (EVD) continues to be a significant public health problem in sub-Saharan Africa, especially in the Democratic Republic of the Congo (DRC). Large-scale vaccination during outbreaks may reduce virus transmission. We established a large population-based clinical trial of a heterologous, two-dose prophylactic vaccine during an outbreak in eastern DRC to determine vaccine effectiveness.<h4>Methods and analysis</h4>This open-label, non-randomised, population-based trial enrolled eligible adults and children aged 1 year and above. Participants were offered the two-dose candidate EVD vaccine regimen VAC52150 (Ad26.ZEBOV, Modified Vaccinia Ankara (MVA)-BN-Filo), with the doses being given 56 days apart. After vaccination, serious adverse events (SAEs) were p2022-01-01T00:00:00Z2022 Mar2026-05-31T03:00:27.496Z2024-11-20T22:33:32.652ZS-EPMC89059413526045810.1136/bmjopen-2021-055596