Bottazzi Maria Elena, Brown Ami Shah
Department of Microbiology, Immunology and Tropical Medicine, The George Washington University, 2300 Eye Street NW, Ross Hall, Washington, DC 20037, USA.
Expert Rev Vaccines. 2008 Dec;7(10):1481-92. doi: 10.1586/14760584.7.10.1481.
This article provides an overview of the advances in product development and technology transfer of the vaccine against human hookworm, with particular emphasis on the lessons learned and the challenges of developing a vaccine in the nonprofit sector. The comprehensive approach to vaccine development established by the Human Hookworm Vaccine Initiative (HHVI) identifies key operational and technical aspects that are essential for a successful partnership with a developing country vaccine manufacturer. This article also highlights the importance of a global access roadmap to guide the vaccine development program. The advancement of new products for the control of neglected tropical diseases portends great challenges for global access, including aspects related to vaccine design, product development and manufacture, vaccine introduction and distribution, financing, knowledge dissemination and intellectual property management. With only three vaccines for neglected tropical diseases in clinical trials - hookworm, leishmaniasis and schistosomiasis - we are at the nascent stages of developing vaccines for neglected populations. Product development public-private partnerships, such as the HHVI, continue to show great promise on this front and will eventually provide significant control tools for achieving millennium development goals related to poverty reduction, as well as child and maternal health.
本文概述了抗人钩虫疫苗在产品开发和技术转让方面的进展，特别强调了所吸取的经验教训以及在非营利部门开发疫苗所面临的挑战。人类钩虫疫苗倡议组织（HHVI）确立的全面疫苗开发方法确定了与发展中国家疫苗制造商成功合作所必需的关键运营和技术方面。本文还强调了全球准入路线图对指导疫苗开发计划的重要性。用于控制被忽视热带病的新产品的研发给全球准入带来了巨大挑战，包括与疫苗设计、产品开发与生产、疫苗引入与分发、融资、知识传播和知识产权管理等相关的方面。目前仅有三种用于被忽视热带病的疫苗处于临床试验阶段——钩虫疫苗、利什曼病疫苗和血吸虫病疫苗——我们在为被忽视人群研发疫苗方面仍处于初期阶段。诸如HHVI这样的公私合营产品开发伙伴关系在这方面继续展现出巨大潜力，并最终将为实现与减贫以及儿童和孕产妇健康相关的千年发展目标提供重要的控制手段。
