biostudies-literatureUnknown13(9)Wu L<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 coHuman vaccines & immunotherapeutics2078-2085https://www.ebi.ac.uk/biostudies/studies/S-EPMC5612469biostudies-literatureOpen-label phase I clinical trial of Ad5-EBOV in Africans in China.PMC5612469Liu JWu LWu NXin QLiu PGao HOu HWu GLi LShentu JWang LLang GHou LQiu YLi YSheng JZhai YZhang ZLuo LWu SChen WYao HLin MWu XfalseOpen-label phase I clinical trial of Ad5-EBOV in Africans in China.<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 co2017-01-01T00:00:00Z2017 Sep2026-05-04T11:22:21.532Z2019-03-26T23:46:09ZS-EPMC56124692870896210.1080/21645515.2017.1342021