用于疟疾疫苗研发的新大陆猴功效试验：关键路径还是弯路？

New World monkey efficacy trials for malaria vaccine development: critical path or detour?

作者信息

Heppner D G, Cummings J F, Ockenhouse C, Kester K E, Lyon J A, Gordon D M

机构信息

Malaria Vaccine Program, Division of Communicable Diseases and Immunology, Walter Reed Army Institute of Research, Silver Spring, MD 20910, USA.

出版信息

Trends Parasitol. 2001 Sep;17(9):419-25. doi: 10.1016/s1471-4922(01)02012-8.

DOI:10.1016/s1471-4922(01)02012-8

PMID:11530353

Abstract

Neither GMP malaria antigens nor GMP vaccines have been compared for efficacy in monkeys and humans. It is too risky to base categorical (go/no go) development decisions on results obtained using partially characterized (non-GMP) antigens, adjuvants that are too toxic for human use or unvalidated primate models. Such practices will lead to serious errors (e.g. failure to identify and stop flawed efforts, rejection of effective vaccine strategies) and unjustifiable delays. Successful malaria vaccine development will emphasize definitive field trials in populations at risk of malaria to define and improve vaccine efficacy.

摘要

既没有在猴子和人类身上比较过药品生产质量管理规范（GMP）的疟疾抗原和GMP疫苗的疗效。基于使用部分特性化（非GMP）抗原、对人类使用毒性过大的佐剂或未经验证的灵长类动物模型所获得的结果来做出绝对的（通过/不通过）开发决策风险太大。此类做法将导致严重错误（例如未能识别并终止有缺陷的工作、拒绝有效的疫苗策略）以及不合理的延误。成功的疟疾疫苗开发将着重在有疟疾风险的人群中开展确定性的现场试验，以确定并提高疫苗疗效。