实验性埃博拉疫苗rVSV-ZEBOV在几内亚进行的大规模临床试验最终结果表明，该疫苗对埃博拉病毒具有高度保护作用，这是首个能够预防这种致命病原体的疫苗。1该试验于2015年进行，共有11841人参与。1在接种疫苗的5837人中，自接种后10天或以上期间未报告埃博拉病例，而未接种对照组则出现23例病例。1
疫苗的安全性状况良好。1约50%的接种者报告了轻微不良反应，包括头痛、疲劳和肌肉酸痛，这些症状在数日内恢复。1仅有2例严重不良反应与疫苗相关——分别为发热反应和过敏反应——另有1例可能与疫苗相关。1
默克公司因此获得美国食品药品监督管理局的突破性疗法认证和欧洲药品管理局的PRIME认证。1该公司已承诺提供30万剂用于紧急使用，并计划于2017年底前提交许可申请。1为支持疫苗的采购和使用，GAVI疫苗联盟提供了500万美元资金。1
A large-scale clinical trial of the experimental Ebola vaccine rVSV-ZEBOV conducted in Guinea has demonstrated high protective efficacy against the virus, marking the first vaccine capable of preventing infection from this highly lethal pathogen.1 The trial involved 11,841 participants and found that among 5,837 vaccinated individuals, no cases of Ebola occurred at least 10 days after vaccination, whereas 23 cases emerged in the unvaccinated group.1 Merck has received breakthrough therapy designation from the U.S. Food and Drug Administration and PRIME designation from the European Medicines Agency.1
The trial employed a ring vaccination strategy, identifying 117 clusters with an average of 80 people each.1 Approximately 50% of vaccinated participants reported mild symptoms including headache, fatigue, and muscle aches, which resolved within days.1 Two serious adverse reactions were determined to be vaccine-related, consisting of a febrile reaction and one allergic reaction, while one additional case was considered possibly related.1 In support of vaccine accessibility, the GAVI Alliance provided $5 million for vaccine procurement.1 Merck committed to supplying 300,000 doses for emergency use and pledged to submit a licensing application by the end of 2017.1
评论
还没有评论，欢迎留下第一条。