A simple, multivalent vaccine to prevent Zika and Chikungunya: progression and readiness to phase II trial

该项目的目的是推进一种新的双价疫苗的临床开发，这种疫苗能够明智地诱导对寨卡病毒和基孔肯雅病毒(ZIKV和CHIKV)的同时保护。这两种疾病通过与登革热相同的蚊子种类传播，因此在相同的地理区域和相同的人口中造成严重的疾病负担，特别是在低收入和中等收入国家。目前还没有预防寨卡病毒或基孔肯雅热感染的疫苗，尽管任何一种疫苗都对减轻这些脆弱人群的疾病负担特别有用，但与单一疫苗相比，双价疫苗将通过简化疫苗接种活动以更低的成本进一步支持全球健康。由于引起格林-巴利综合征等神经系统疾病和新生儿小头畸形症发病率增加20倍，寨卡病毒感染是世界范围内的一个主要问题。在大约四分之三的感染者中，CHIKV感染会导致类似流感的症状性疾病，并可能导致所有年龄段的患者出现疼痛和虚弱的长期关节炎。持续性关节炎可能会持续数年，导致残疾和无法工作。长期的后遗症以及对寨卡病毒和CHIKV感染缺乏专门治疗，在卫生系统薄弱且已经被登革热等其他虫媒病毒疾病或SARS-CoV-2等无关疫情压垮的地区，家庭和政府的贫困和高昂的费用。贫穷和移民等社会经济因素，加上气候变化，增加了蚊子生活和传播病毒的地理区域。一项重大突破和理想的预防性解决方案将是提供一种双价疫苗，同时抗击寨卡病毒和基孔肯雅热。这项提案旨在利用在这两种疾病流行的墨西哥完成的Ib阶段试验中收集的结果和样本。这个为期12个月的项目将使合作伙伴能够推进技术工具和合作，为IIb期临床试验做好准备。

The aim of this project is to progress the clinical development of a new bivalent vaccine that judiciously induces simultaneous protection against Zika and chikungunya viruses (ZIKV and CHIKV). These two diseases are transmitted by the same mosquito specie as dengue, therefore causing a severe disease burden in the same geographical regions and in the same populations, particularly in low-and-middle-income countries. There is currently no vaccine to prevent Zika or chikungunya infections, and while any one vaccine would be particularly useful to reduce the disease burden in these vulnerable populations, a bivalent vaccine would further support global health by simplifying vaccination campaigns at lower costs when compared to single vaccine campaigns. Infection by ZIKV is a major concern worldwide due to causing neurologic conditions, such as Guillain-Barré syndrome and a 20-fold increase in the incidence of neonatal microcephaly. Infection by CHIKV results in a flu-like symptomatic disease in approximately three quarters of infected people, and may lead to painful and debilitating long-term arthritis in patients of all ages. Persistent arthritis may last for years causing disability and inability to work. Long-term sequelae and lack of specific treatment for ZIKV and CHIKV infections contribute to poverty and high costs for families and governments in areas where the health system is weak and already overwhelmed by other arbovirus diseases such as dengue or by unrelated outbreaks such as SARS-CoV-2\. Socioeconomical factors such as poverty and migration, together with climate change, increase the geographical regions where the mosquitoes live and transmit the viruses. A major breakthrough and an ideal preventive solution would be to provide a bivalent vaccine to simultaneously fight Zika and chikungunya. This proposal aims to leverage the findings and samples collected during a Phase Ib trial that has been completed in Mexico, where both diseases are prevalent. This 12-month project will enable the partners to advance the technical tools and collaborations ready for a phase IIb clinical trial.