Two proof of concept clinical trials with TB vaccines demonstrate that new approaches can prevent sustained TB infection in adolescents (BCG revaccination) and TB disease in adults (M72/ASO1E) (Nemes et al., 2018; Tait et al., 2019) [1,2]. Both approaches are in late stage development and provide motivation and rationale to invest into a global TB vaccine pipeline. This pipeline needs to be diverse to address TB-specific challenges including variation in target populations, uncertainties in animal model predictivity and lack of immune correlates of protection. It requires that individual vaccine candidates must be advanced rationally and that the global pipeline must be managed in the most nimble and resource-efficient way, especially in the current constrained funding environment. The TB Vaccine Development Pathway is a webtool which has been developed as an offer to the field to provide a source of information and guidance covering vaccine development from discovery to implementation. It is underpinned by generic and TB vaccine-specific guidelines, regulatory frameworks and best practice, and was compiled by a multi-disciplinary team of scientific and technical experts with the input of the TB vaccine community. The Pathway is a unique tool to guide and accelerate the development of TB vaccine candidates and may be useful for other vaccine development fields.

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结核病疫苗开发途径——一种加速全球结核病疫苗开发的创新方法

两项结核病疫苗概念临床试验证明，新方法可以预防青少年持续性结核病感染（卡介苗复种）和成人结核病（M72/ASO1E）（Nemes 等人，2018 年；Tait 等人，2019 年）[ 1,2]。这两种方法都处于开发后期，为投资全球结核病疫苗管道提供了动力和理由。该管道需要多样化，以应对特定于结核病的挑战，包括目标人群的变化、动物模型预测的不确定性以及缺乏免疫相关保护。它要求个体候选疫苗必须合理推进，并且必须以最灵活和资源高效的方式管理全球管道，尤其是在当前资金紧张的环境下。结核病疫苗开发途径是一种网络工具，已开发为该领域的产品，旨在提供涵盖疫苗开发从发现到实施的信息和指导来源。它以通用和结核病疫苗特定指南、监管框架和最佳实践为基础，由多学科科学和技术专家团队在结核病疫苗界的投入下编制而成。该途径是指导和加速结核病候选疫苗开发的独特工具，可能对其他疫苗开发领域有用。并由多学科的科技专家团队在结核病疫苗界的投入下编制而成。该途径是指导和加速结核病候选疫苗开发的独特工具，可能对其他疫苗开发领域有用。并由多学科的科技专家团队在结核病疫苗界的投入下编制而成。该途径是指导和加速结核病候选疫苗开发的独特工具，可能对其他疫苗开发领域有用。