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

我们建议对含有基质- m佐剂的新候选疫苗R21进行评估，以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传播降至非常低的水平。大量给药的增加在短时间内减少甚至中断了传播。一种能够提供较长时间（尽管是有限的）保护的疫苗可能足以在区域一级永久阻断疟疾传播。为了在区域一级推广大规模疫苗接种，有必要证明，在大湄公河次区域目前面临疟疾风险的人群中，疫苗具有良好的耐受性，并在与抗疟疾药物共同接种时引发预期的免疫反应。我们在此提出一项健康的志愿者研究，以证明含有matrix-M的候选疫苗R21在泰国具有良好的耐受性和免疫原性。这项研究将在泰国曼谷玛希隆大学的健康志愿者中进行。疫苗方案将包括三个疫苗剂量，间隔一个月。每一剂疫苗将与三剂抗疟药物（双氢青蒿素/哌喹和单一低剂量伯氨喹）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规模的试验，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。

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.