PDF(Pubmed)
Abstract：
Malaria eradication efforts prioritize safe and efficient vaccination strategies, although none with high-level efficacy against malaria infection are yet available. Among several vaccine candidates, Sanaria® PfSPZ Vaccine and Sanaria PfSPZ-CVac are, respectively, live radiation- and chemo-attenuated sporozoite vaccines designed to prevent infection with Plasmodium falciparum, the leading cause of malaria-related morbidity and mortality. We are conducting a randomized normal saline placebo-controlled trial called IDSPZV1 that will analyze the safety, tolerability, immunogenicity, and efficacy of PfSPZ Vaccine and PfSPZ-CVac administered pre-deployment to malaria-naive Indonesian soldiers assigned to temporary duties in a high malaria transmission area. We describe the manifold challenges of enrolling and immunizing 345 soldier participants at their home base in western Indonesia before their nearly 6,000-km voyage to eastern Indonesia, where they are being monitored for incident P. falciparum and Plasmodium vivax malaria cases during 9 months of exposure. The unique regulatory, ethical, and operational complexities of this trial demonstrate the importance of thorough planning, frequent communication, and close follow-up with stakeholders. Effective engagement with the military community and the ability to adapt to unanticipated events have proven key to the success of this trial.
摘要：
消除疟疾的努力优先考虑安全和有效的疫苗接种策略。尽管目前还没有对疟疾感染有高水平疗效的人。在几种候选疫苗中，Sanaria®PfSPZ疫苗和SanariaPfSPZ-CVac是，分别,用于预防恶性疟原虫感染的活的放射和化学减毒的子孢子疫苗，疟疾相关发病率和死亡率的主要原因。我们正在进行一项名为IDSPZV1的随机生理盐水安慰剂对照试验，该试验将分析安全性，耐受性,免疫原性,PfSPZ疫苗和PfSPZ-CVac的效力，在部署前对在疟疾高传播地区被分配到临时职责的幼稚的印度尼西亚士兵进行了管理。我们描述了在前往印度尼西亚东部近6,000公里的航行之前，在印度尼西亚西部的基地招募和免疫345名士兵的挑战。在9个月的接触期间，他们正在监测恶性疟原虫和间日疟原虫疟疾病例。独特的监管，伦理,这项试验的操作复杂性证明了周密计划的重要性，频繁的沟通,并与利益相关者密切跟进。事实证明，与军事界的有效接触以及适应意外事件的能力是这项试验成功的关键。
