MALARIA VACCINE DEVELOPMENT UNIT (MVDU)

疟疾疫苗和开发股（MVDU）的目标是开发候选疫苗，以便在志愿者和流行人群中进行测试，并探索用于疫苗开发的下一个测试想法（管道）。工艺开发将在单位内进行，临床级材料将外包生产。该装置将能够通过细菌和酵母（毕赤酵母和酵母菌）发酵生产重组蛋白，并进行细胞培养；用可用于GMP生产的方法纯化蛋白质；开发释放规格和评估蛋白质功效的检测方法。它还将有一个单位在猕猴身上进行重组蛋白的测试，并在实地试验中进行有效性测试。现在有三种产品即将进入测试阶段。其中两个与阻断恶性疟原虫和间日疟原虫传播的疫苗有关，另一个是针对MSP1的c端。MSP1疫苗正在以不同的方式生产，不久将在猴子身上进行试验，为实地试验做准备。-疟疾疫苗，血液阶段疫苗，传播阻断疫苗-人类受试者

The Malaria Vaccine and Development Unit (MVDU) has as its goal the development of candidate vaccines to the point of testing in volunteers and in endemic people and the exploration of the next ideas for testing for vaccine development (the pipeline). The process development will proceed within the unit, and the clinical grade material will be outsourced for production. The unit will be able to produce recombinant proteins by fermentation in bacteria and yeast (Pichia and Saccharomyces) and do cell culture; purify proteins by methods that will be transferable for GMP production; and develop assays for release specifications and for evaluating the efficacy of proteins. It will also have a unit to do tests of recombinant proteins in Aotus monkeys and in field trials for efficacy.There are now three products that are approaching readiness for testing. Two are related to transmission blocking vaccines for P. falciparum and P. vivax and one is against the C-terminus of MSP1. The MSP1 vaccines are being made in different ways and will soon be tested in monkeys in preparation for field trials. - Malaria vaccine, blood stage vaccines, transmission-blocking vaccine - Human Subjects