Open-label phase I clinical trial of Ad5-EBOV in Africans in China. Issue 9 (2nd September 2017)

• Record Type: Journal Article
• Authors: Wu, Lihua; Zhang, Zhe; Gao, Hainv; Li, Yuhua; Hou, Lihua; Yao, Hangping; Wu, Shipo; Liu, Jian; Wang, Ling; Zhai, You; Ou, Huilin; Lin, Meihua; Wu, Xiaoxin; Liu, Jingjing; Lang, Guanjing; Xin, Qian; Wu, Guolan; Luo, Li; Liu, Pei; Shentu, Jianzhong; Wu, Nanping; Sheng, Jifang; Qiu, Yunqing; Chen, Wei; Li, Lanjuan
• Is Part Of: Human vaccines & immunotherapeutics. Volume 13:Issue 9(2017)
• Page Start: 2078
• Page End: 2085
• Publication Date: 2017-09-02
• Subjects: Ad5-EBOV -- GP antibody -- immunogenicity -- safety -- T-cell response; Vaccines -- Periodicals; 615.372
• DOI: 10.1080/21645515.2017.1342021
• Languages: English
• ISSNs: 2164-5515

Abstract

ABSTRACT: 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 d 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 d of vaccination. The most common reaction was fever and the mild pain at injection site, and there were no significant difference between these 2 groups. Ebola glycoprotein-specific antibodies appeared in all 61 participants and antibodies titers peaked after 28 d of vaccination. The geometric mean titres (GMTs) were similar between these 2 groups (1919.01 vs 1684.70 P = 0.5562 ). The glycoprotein-specific T-cell responses rapidly peaked after 14 d of vaccination and then decreased, however, the percentage of subjects with responses were much higher in the high-dose group (60.00% vs 9.68%, P = 0.0014 ). Pre-existing Ad5 neutralizing antibodies could significantly dampen the specific humoral immune response and cellular response to the vaccine. Conclusion : The application of Ad5-EBOV demonstrated safe in Africans in China and a specific GP antibody and T-cell response could occur 14 d after the first immunization. This acceptable safety profile provides a reliable basis to proceed with trials in Africa.