{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["13(9)"],"submitter":["Wu L"],"pubmed_abstract":["<h4>Background</h4>To determine the safety and immunogenicity of a novel recombinant adenovirus type 5 vector based Ebola virus disease vaccine (Ad5-EBOV) in Africans in China.<h4>Methods</h4>A phase 1, dose-escalation, open-label trial was conducted. 61 healthy Africans were sequentially enrolled, with 31 participants receiving one shot intramuscular injection and 30 participants receiving a double-shot regimen. Primary and secondary end points related to safety and immunogenicity were assessed within 28 d after vaccination. This study was registered with ClinicalTrials.gov (NCT02401373).<h4>Results</h4>Ad5-EBOV is well tolerated and no adverse reaction of grade 3 or above was observed. 53 (86.89%) participants reported at least one adverse reaction within 28 d of vaccination. The most co"],"journal":["Human vaccines & immunotherapeutics"],"pagination":["2078-2085"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC5612469"],"repository":["biostudies-literature"],"pubmed_title":["Open-label phase I clinical trial of Ad5-EBOV in Africans in China."],"pmcid":["PMC5612469"],"pubmed_authors":["Liu J","Wu L","Wu N","Xin Q","Liu P","Gao H","Ou H","Wu G","Li L","Shentu J","Wang L","Lang G","Hou L","Qiu Y","Li Y","Sheng J","Zhai Y","Zhang Z","Luo L","Wu S","Chen W","Yao H","Lin M","Wu X"],"additional_accession":[]},"is_claimable":false,"name":"Open-label phase I clinical trial of Ad5-EBOV in Africans in China.","description":"<h4>Background</h4>To determine the safety and immunogenicity of a novel recombinant adenovirus type 5 vector based Ebola virus disease vaccine (Ad5-EBOV) in Africans in China.<h4>Methods</h4>A phase 1, dose-escalation, open-label trial was conducted. 61 healthy Africans were sequentially enrolled, with 31 participants receiving one shot intramuscular injection and 30 participants receiving a double-shot regimen. Primary and secondary end points related to safety and immunogenicity were assessed within 28 d after vaccination. This study was registered with ClinicalTrials.gov (NCT02401373).<h4>Results</h4>Ad5-EBOV is well tolerated and no adverse reaction of grade 3 or above was observed. 53 (86.89%) participants reported at least one adverse reaction within 28 d of vaccination. The most co","dates":{"release":"2017-01-01T00:00:00Z","publication":"2017 Sep","modification":"2026-05-04T11:22:21.532Z","creation":"2019-03-26T23:46:09Z"},"accession":"S-EPMC5612469","cross_references":{"pubmed":["28708962"],"doi":["10.1080/21645515.2017.1342021"]}}