Safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in China: preliminary report of a randomised, double-blind, placebo-controlled, phase 1 trial

Publication date: Available online 25 March 2015 Source:The Lancet Author(s): Feng-Cai Zhu , Li-Hua Hou , Jing-Xin Li , Shi-Po Wu , Pei Liu , Gui-Rong Zhang , Yue-Mei Hu , Fan-Yue Meng , Jun-Jie Xu , Rong Tang , Jin-Long Zhang , Wen-Juan Wang , Lei Duan , Kai Chu , Qi Liang , Jia-Lei Hu , Li Luo , Tao Zhu , Jun-Zhi Wang , Wei Chen Background Up to now, all tested Ebola virus vaccines have been based on the virus strain from the Zaire outbreak in 1976. We aimed to assess the safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine expressing the glycoprotein of the 2014 epidemic strain. Methods We did this randomised, double-blind, placebo-controlled, phase 1 clinical trial at one site in Taizhou County, Jiangsu Province, China. Healthy adults (aged 18–60 years) were sequentially enrolled and randomly assigned (2:1), by computer-generated block randomisation (block size of six), to receive placebo, low-dose adenovirus type-5 vector-based Ebola vaccine, or high-dose vaccine. Randomisation was pre-stratified by dose group. All participants, investigators, and laboratory staff were masked to treatment allocation. The primary safety endpoint was occurrence of solicited adverse reactions within 7 days of vaccination. The primary immunogenicity endpoints were glycoprotein-specific antibody titres and T-cell responses at day 28 after the vaccination. Analysis was by intention to treat. The study is registered with Clini...
Source: The Lancet - Category: Journals (General) Source Type: research