MICA: An evaluation of the antimalarial vaccine candidateR21/matrix M for malaria elimination strategy in the Greater Mekong Subregion

MICA：针对大湄公河次区域疟疾消除战略的抗疟候选疫苗 R21/matrix M 的评估

• 批准号: MR/T04473X/1
• 负责人: Lorenz Von Seidlein
• 金额: $ 37.6万
• 依托单位: University of Oxford
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2022
• 资助国家: 英国
• 起止时间: 2022 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FT04473X%2F1
• 关键词: MICA; evaluation; antimalarial; vaccine; candidateR21

We are proposing the evaluation of the new vaccine candidate R21 with matrix-M adjuvant as a malaria elimination tool for the Greater Mekong Subregion. Existing malaria control tools have driven falciparum malaria transmission to very low levels. The addition of mass drug administrations has reduced and even interrupted transmission for short time spans. A vaccine which can confer protection for a longer, albeit limited, time period may be sufficient to interrupt malaria transmission permanently on a regional level.To roll out mass vaccine administrations on a regional level it is necessary to demonstrate that vaccine is well tolerated and triggers the desired immune response when co-administered with antimalarial drugs in the the people currently at risk for malaria in the Greater Mekong Subregion. We propose here a healthy volunteer study to demonstrate that the vaccine candidate R21 with matrix-M is well tolerated and immunogenic in Thailand. This study will be conducted in healthy volunteers at Mahidol University, Bangkok, Thailand. The vaccine regimen will consist of three vaccine doses one month apart. Each vaccine dose will be combined with three doses of antimalarial drugs (dihydroartemisinin / piperaquine and a single low dose primaquine). Study participants will be followed for 6 months to assess their well being and immune responses.If successful we will proceed to the next, larger trial to see whether the vaccine co-administered with antimalarial drugs protects against falciparum malaria, but that will be separate grant application.

我们建议评价新的候选疫苗R21与基质-M佐剂作为大湄公河次区域消除疟疾的工具。现有的疟疾控制工具已将恶性疟疾的传播控制在非常低的水平。大规模药物管理的增加减少了，甚至在短时间内中断了传播。一种能够提供较长（尽管时间有限）保护的疫苗可能足以在区域一级永久阻断疟疾传播。要在区域一级推广大规模疫苗接种，必须证明疫苗具有良好的耐受性，并在大湄公河次区域目前面临疟疾风险的人群中与抗疟药物共同接种时引发所需的免疫反应。我们在此提出了一项健康志愿者研究，以证明具有基质-M的候选疫苗R21在泰国具有良好的耐受性和免疫原性。本研究将在泰国曼谷Mahidol大学的健康志愿者中进行。疫苗方案将包括三次疫苗接种，间隔一个月。每剂疫苗将与三剂抗疟药物（双氢青蒿素/哌喹和一剂低剂量伯氨喹）联合使用。研究参与者将被随访6个月，以评估他们的健康状况和免疫反应。如果成功，我们将进行下一个更大的试验，看看疫苗与抗疟疾药物联合使用是否能预防恶性疟疾，但这将是单独的拨款申请。