Pathway to Deployment of Gene Drive Mosquitoes as a Potential Biocontrol Tool for Elimination of Malaria in Sub-Saharan Africa: Recommendations of a Scientific Working Group
Pathway to Deployment of Gene Drive Mosquitoes as a Potential Biocontrol Tool for Elimination of Malaria in Sub-Saharan Africa: Recommendations of a Scientific Working Group
复制标题
DOI：
10.4269/ajtmh.18-0083
复制
发表时间：
2018-01-01
影响因子：
3.3
通讯作者：
Toure, Yeya T.
中科院分区：
文献类型：
--
作者：
James, Stephanie;Collins, Frank H.;Toure, Yeya T.
基因驱动技术为控制疟疾传播提供了一种高影响、高成本效益和持久的方法，这将对消除疟疾做出重大贡献。基因驱动系统，例如基于聚集的规则间隔短回文重复序列(CRISPR)/CRISPR相关蛋白的系统，有可能通过疟疾蚊子的杂交种群传播有益的特征。然而，这项技术的特点引起了人们的关注，需要仔细考虑产品开发途径。一个多学科工作组审议了低门槛基因驱动系统对《世界卫生组织转基因蚊子检测指导框架》所述发展途径的影响，重点是减少冈比亚按蚊传播疟疾。以非洲的蚊子为例。该小组借鉴了其他病媒控制工具、转基因生物和生防剂的先前经验，提出了对基因驱动蚊子进行安全和道德测试的建议。这些建议是根据一项测试计划组织的，该计划寻求通过逐步增加人类和环境对研究产品的暴露程度来最大化安全性。与生防剂一样，重点是在物理受限的实验室测试结束时进行安全性评估，作为是否进入现场测试的主要决策点。在测试过程中的进展基于安全性和有效性标准的满足，并受到监管和伦理批准以及社会的接受。工作组确定了几种被认为对支持负责任的基因驱动蚊子现场测试很重要的资源。
Gene drive technology offers the promise for a high-impact, cost-effective, and durable method to control malaria transmission that would make a significant contribution to elimination. Gene drive systems, such as those based on clustered regularly interspaced short palindromic repeats (CRISPR)/CRISPR associated protein, have the potential to spread beneficial traits through interbreeding populations of malaria mosquitoes. However, the characteristics of this technology have raised concerns that necessitate careful consideration of the product development pathway. A multi-disciplinary working group considered the implications of low-threshold gene drive systems on the development pathway described in the World Health Organization Guidance Framework for testing genetically modified (GM) mosquitoes, focusing on reduction of malaria transmission by Anopheles gambiae s.l. mosquitoes in Africa as a case study. The group developed recommendations for the safe and ethical testing of gene drive mosquitoes, drawing on prior experience with other vector control tools, GM organisms, and biocontrol agents. These recommendations are organized according to a testing plan that seeks to maximize safety by incrementally increasing the degree of human and environmental exposure to the investigational product. As with biocontrol agents, emphasis is placed on safety evaluation at the end of physically confined laboratory testing as a major decision point for whether to enter field testing. Progression through the testing pathway is based on fulfillment of safety and efficacy criteria, and is subject to regulatory and ethical approvals, as well as social acceptance. The working group identified several resources that were considered important to support responsible field testing of gene drive mosquitoes.