Clinical Trial of Ad 5-EBOV in Africans in China

Background: 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. Methods: 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 days after vaccination. This study was registered with ClinicalTrials.gov (NCT02401373). Results: 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 days of vaccination. The most common reaction was fever and the mild pain at injection site, and there were no significant difference between these two groups. Ebola glycoproteinspecific antibodies appeared in all 61 participants and antibodies titers peaked after 28 days of vaccination. The geometric mean titres (GMTs) were similar between these two