A framework for Controlled Human Infection Model (CHIM) studies in Malawi: Report of a Wellcome Trust workshop on CHIM in Low Income Countries held in Blantyre, Malawi.
A framework for Controlled Human Infection Model (CHIM) studies in Malawi: Report of a Wellcome Trust workshop on CHIM in Low Income Countries held in Blantyre, Malawi.
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DOI：
10.12688/wellcomeopenres.12256.1
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发表时间：
2017
影响因子：
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通讯作者：
Wellcome Trust CHIM workshop participants
中科院分区：
文献类型：
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作者：
Gordon SB;Rylance J;Luck A;Jambo K;Ferreira DM;Manda-Taylor L;Bejon P;Ngwira B;Littler K;Seager Z;Gibani M;Gmeiner M;Roestenberg M;Mlombe Y;Wellcome Trust CHIM workshop participants
控制性人类感染模型（CHIM）研究在疫苗开发中具有关键意义，可用于概念验证、发病机制、下选择和免疫原性研究，但迄今为止，在中低收入国家（LMIC）很少开展，这是疫苗可预防疾病的最大负担。本次研讨会讨论了马拉维CHIM研究的好处和障碍。好处包括提高疫苗的有效性和东道国在临床、实验室和管理领域的能力发展，障碍包括可接受性、安全性和监管问题。该报告提出了一个框架，通过该框架，伦理，实验室，科学和治理问题可以由考虑或计划在LMIC CHIM的调查人员解决。
Controlled human infection model (CHIM) studies have pivotal importance in vaccine development, being useful for proof of concept, pathogenesis, down-selection and immunogenicity studies. To date, however, they have seldom been carried out in low and middle income countries (LMIC), which is where the greatest burden of vaccine preventable illness is found. This workshop discussed the benefits and barriers to CHIM studies in Malawi. Benefits include improved vaccine effectiveness and host country capacity development in clinical, laboratory and governance domains. Barriers include acceptability, safety and regulatory issues. The report suggests a framework by which ethical, laboratory, scientific and governance issues may be addressed by investigators considering or planning CHIM in LMIC.