中国埃博拉疫苗I期临床试验效果好 WHO启动疫区临床实验
2015/03/27
美国、加拿大研究的1976基因型埃博拉疫苗需零下80摄氏度冷冻保存和运输;而我国研制的2014基因型疫苗I期临床试验安全有效,可应对当下的埃博拉疫情和今后的疫情防控;稳定性好,首创冻干型疫苗,常温下可稳定2周以上,适合西非热带地区使用,并具备大规模生产技术条件,满足疫情防控急需。


The Lancet:中国埃博拉疫苗I期临床试验安全有效

3月24日,世界顶级医学杂志《柳叶刀》(The Lancet),全文发表我国2014基因型埃博拉疫苗I期临床试验研究成果。

疫苗由军事医学科学院生物工程研究所陈薇创新团队和天津康希诺生物技术有限公司联合研发。埃博拉疫情发生后,我国立即启动重大传染病联防联控工作机制,总后勤部会同国家食品药品监督管理总局,运用特别审评程序,确保世界第一个2014基因型疫苗进入临床。

疫苗临床试验由江苏省疾控中心研究员朱凤才主持,在泰州中国医药城完成了对120名志愿者的剂量递增、随机双盲、安慰剂对照I期临床试验,结果表明,疫苗安全性好,主要不良反应为注射部位疼痛,未发生严重不良事件,接种后14天细胞免疫水平达到最高,28天抗体水平达到峰值,提前2周接种可以实现免疫保护。

据悉,目前美国、加拿大正在进行临床研究的埃博拉疫苗均为1976基因型,系液体制剂,需零下80摄氏度冷冻保存和运输。我国的疫苗为2014基因型,针对性强,可应对当下的埃博拉疫情和今后的疫情防控;稳定性好,首创冻干型疫苗,常温下可稳定2周以上,适合西非热带地区使用,并具备大规模生产技术条件,满足疫情防控急需。

WHO:启动疫区临床实验 最早或在7月揭晓结果

此外,世界卫生组织25日表示,由该机构和几内亚政府共同开展的首次埃博拉疫苗的临床疗效实验已于当天在几内亚境内一个受埃博拉疫情影响最为严重的社区启动。

世卫组织驻几内亚代表让-马里·当古(Jean-Marie Dangou)指出,这一实验不仅是抗击埃博拉过程中最为重要的里程碑之一,而且给几内亚以及全世界的民众带来了希望。因为,如果实验证实疫苗安全有效,公共卫生部门就有可能很快拥有一个抗击埃博拉有效工具。

根据计划,在4至6周的时间内,医务人员将对1万名自愿者进行埃博拉疫苗接种,并对他们的情况进行为期3月的监测和追踪。实验结果最早可望于7月15日揭晓。

据悉,此次实验所采用的VSV-EBOV疫苗由加拿大公共卫生署开发完成。基于上世纪70年代用来消灭天花的方法,这次采取的试验策略为“环围接种式”,即在发现病例后允许部分新诊断埃博拉病例的接触者立刻获得疫苗接种,而周围其他人员将在3周之后获得疫苗接种。这种试验设计尽管对部分人员而言会有短暂拖延,但在研究结束时会使所有接触者得到接种,而不像标准研究方法那样采用安慰剂。

据统计,截至3月18日,在几内亚、利比里亚、塞拉利昂三个受埃博拉疫情影响最为严重的西非国家,共发现24666起埃博拉感染确诊或疑似病例,其中10179人死亡。

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  • 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

    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 ClinicalTrials.gov, number NCT02326194. Findings Between Dec 28, 2014, and Jan 9, 2015, 120 participants were enrolled and randomly assigned to receive placebo (n=40), low-dose vaccine (n=40), or high-dose vaccine. Participants were followed up for 28 days. Overall, 82 (68%) participants reported at least one solicited adverse reaction within 7 days of vaccination (n=19 in the placebo group vs n=27 in the low-dose group vs n=36 in the high-dose group; p=0·0002). The most common reaction was mild pain at the injection site, which was reported in eight (20%) participants in the placebo group, 14 (35%) participants in the low-dose group, and 29 (73%) participants in the high-dose vaccine group (p<0·0001). We recorded no statistical differences in other adverse reactions and laboratory tests across groups. Glycoprotein-specific antibody titres were significantly increased in participants in the low-dose and high-dose vaccine groups at both day 14 (geometric mean titre 421·4 [95% CI 249·7–711·3] and 820·5 [598·9–1124·0], respectively; p<0·0001) and day 28 (682·7 [424·3–1098·5] and 1305·7 [970·1–1757·2], respectively; p<0·0001). T-cell responses peaked at day 14 at a median of 465·0 spot-forming cells (IQR 180·0–1202·5) in participants in the low-dose group and 765·0 cells (400·0–1460·0) in those in the high-dose group. 21 (18%) participants had mild fever (n=9 in the placebo group, n=6 in the low-dose group, and n=6 in the high-dose group). No serious adverse events were recorded. Interpretation Our findings show that the high-dose vaccine is safe and robustly immunogenic. One shot of the high-dose vaccine could mount glycoprotein-specific humoral and T-cell response against Ebola virus in 14 days. Funding China National Science and Technology, Beijing Institute of Biotechnology, and Tianjin CanSino Biotechnology.

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