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首页> 外文期刊>Vaccine >MALVAC 2009: Progress and Challenges in Development of Whole Organism Malaria Vaccines for Endemic Countries, 3-4 June 2009, Dakar, Senegal
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MALVAC 2009: Progress and Challenges in Development of Whole Organism Malaria Vaccines for Endemic Countries, 3-4 June 2009, Dakar, Senegal

机译：MALVAC 2009：针对流行国家的全生物疟疾疫苗开发的进展和挑战，2009年6月3-4日，塞内加尔达喀尔

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摘要

Research and development into whole organism malaria vaccines is progressing rapidly thanks to the major investments over recent years from several funders, and the commitment and interest of many leading researchers. Progress includes the discovery of potential new candidate vaccines and the start of the first phase 1/2a clinical trial of the radiation attenuated sporozoite approach for Plasmodium falciparum, under US Food and Drug Administration regulatory oversight. A group of leading scientists, clinical trialists and stakeholders, together with representatives of regulatory authorities including some from African countries, met recently to document the issues that will require detailed consideration to assess this promising approach. Questions related to scale-up, quality, purity and consistency of a manufacturing process using mosquitoes to generate a commercial product, and demonstration of the stability of attenuated sporozoites will need further work. Should a high level of efficacy be demonstrated in clinical challenge studies, it will become a priority to agree in which populations and age groups questions about strain-transcendence and duration of efficacy should be answered, and how clinical development can progress with an approach based on cryopreservation in liquid nitrogen.
机译：近年来，由于几位资助者的重大投资以及许多领先研究人员的投入和兴趣，对全生物疟疾疫苗的研究与开发正在迅速发展。进展包括发现潜在的新候选疫苗，并在美国食品和药物管理局的监管监督下，开始进行恶性疟原虫辐射衰减子孢子方法的第1 / 2a期临床试验。一群领先的科学家，临床试验人员和利益相关者，以及包括来自非洲国家的监管机构在内的监管机构的代表最近开会，记录了需要详细考虑以评估这种有前途的方法的问题。与蚊子生产商业产品的生产过程的规模，质量，纯度和一致性有关的问题，以及减毒子孢子稳定性的证明还需要进一步的工作。如果在临床挑战研究中证明了高水平的疗效，则将成为一个优先事项，即应在哪个人群和年龄组中回答有关应变超越性和疗效持续时间的问题，以及基于在液氮中冷冻保存。

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