{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Watson-Jones D"],"funding":["Horizon 2020 Framework Programme","Department for International Development","Medical Research Council","Coalition for Epidemic Preparedness Innovations","Wellcome Trust","Paul G. Allen Family Foundation"],"pagination":["e055596"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8905941"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["12(3)"],"pubmed_abstract":["<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 p"],"journal":["BMJ open"],"pubmed_title":["Protocol 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."],"pmcid":["PMC8905941"],"funding_grant_id":["MR/R010161/1","857935","220506/Z/20/Z","FELS1903"],"pubmed_authors":["Johnson J","Grais RF","Luhn K","Choi EM","Leyssen M","Roberts CH","Bausch DG","Kavunga-Membo H","Hatchett R","Kighoma PM","Camacho A","Lees S","Ahuka S","Manno D","Rattigan S","Delaporte E","Smith PG","Saville M","Edwards T","Mambula G","Burton M","John Edmunds W","DRC-EB-001 protocol writing team","Spiessens B","Douoguih M","Muyembe JJ","Voss G","Greenwood B","Longini IM","Edmunds WJ","Roberts N","Imbault N","Grais R","Watson-Jones D"],"additional_accession":[]},"is_claimable":false,"name":"Protocol 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.","description":"<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 p","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Mar","modification":"2026-05-31T03:00:27.496Z","creation":"2024-11-20T22:33:32.652Z"},"accession":"S-EPMC8905941","cross_references":{"pubmed":["35260458"],"doi":["10.1136/bmjopen-2021-055596"]}}