Buis Joeri S, Jerene Degu, Gebhard Agnes, Bakker Roel, Majidulla Arman, Kerkhoff Andrew D, Limaye Rupali J, Pelzer Puck T
KNCV Tuberculosis Foundation, The Hague, The Netherlands.
Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Maryland, United States of America.
PLOS Glob Public Health. 2024 Aug 22;4(8):e0002885. doi: 10.1371/journal.pgph.0002885. eCollection 2024.
There is global consensus on the urgent need for a safe and effective TB vaccine for adults and adolescents to improve global TB control, and encouragingly, several promising candidates have advanced to late-stage trials. Significant gaps remain in understanding the critical factors that will facilitate the successful implementation of new and repurposed TB vaccines in low- and middle-income countries (LMICs), once available. By synthesizing the existing body of knowledge, this review offers comprehensive insights into the current state of research on implementation of these adult and adolescent vaccines. This review explores four key dimensions: (1) epidemiological impact, (2) costing, cost-effectiveness, and/or economic impact, (3) acceptability, and the (4) feasibility of implementation; this includes implementation strategies of target populations, and health system capabilities. Results indicate that current research primarily consists of epidemiological and costing/cost-effectiveness/economic studies in India, China, and South Africa, mainly modelling with M72/AS01, BCG revaccination, and hypothetical vaccines. Varying endpoints, vaccine efficacies, and vaccination coverages were used. Globally, new, and repurposed TB vaccines are estimated to save millions of lives. Economically, these vaccines also demonstrate promise with expected cost-effectiveness in most countries. Projected outcomes were dependent on vaccine characteristics, target population, implementation strategy, timing of roll out, TB burden/country context, and vaccination coverage. Potential barriers for vaccine acceptability included TB-related stigma, need for a second dose, and cost, while low pricing, community and civil society engagement and heightened public TB awareness were potential enablers in China, India, and South Africa. Potential implementation strategies considered spanned from mass campaigns to integration within existing vaccine programs and the primary target group studied was the general population, and adults and adolescents. In conclusion, future research must have broader geographical representations to better understand what is needed to inform tailored vaccine programs to accommodate diverse country contexts and population groups to achieve optimal implementation and impact. Furthermore, this review underscores the scarcity of research on acceptability of new and repurposed TB vaccines and their delivery among potential beneficiaries, the most promising implementation strategies, and the health system capabilities necessary for implementation. The absence of this knowledge in these areas emphasizes the crucial need for future research to ensure effective TB vaccine implementation in high burden settings worldwide.
全球已达成共识，迫切需要为成年人和青少年研发一种安全有效的结核病疫苗，以改善全球结核病防控状况。令人鼓舞的是，有几种很有前景的候选疫苗已进入后期试验阶段。一旦新型和重新利用的结核病疫苗问世，在理解促进其在低收入和中等收入国家（LMICs）成功实施的关键因素方面，仍存在重大差距。通过综合现有知识体系，本综述对这些针对成人和青少年的疫苗实施研究现状提供了全面见解。本综述探讨了四个关键维度：（1）流行病学影响，（2）成本、成本效益和/或经济影响，（3）可接受性，以及（4）实施的可行性；这包括目标人群的实施策略和卫生系统能力。结果表明，当前研究主要包括在印度、中国和南非进行的流行病学以及成本/成本效益/经济研究，主要是对M72/AS01、卡介苗复种和假设疫苗进行建模。使用了不同的终点、疫苗效力和疫苗接种覆盖率。在全球范围内，新型和重新利用的结核病疫苗预计可挽救数百万人的生命。在经济方面，这些疫苗在大多数国家的预期成本效益也显示出前景。预计结果取决于疫苗特性、目标人群、实施策略、推出时间、结核病负担/国家背景以及疫苗接种覆盖率。疫苗可接受性的潜在障碍包括与结核病相关的耻辱感、需要接种第二剂以及成本，而在中国、印度和南非，低价格、社区和民间社会参与以及公众对结核病意识的提高是潜在的推动因素。考虑的潜在实施策略涵盖从大规模运动到纳入现有疫苗计划，研究的主要目标群体是一般人群以及成年人和青少年。总之，未来的研究必须有更广泛的地域代表性，以更好地了解需要什么来制定量身定制的疫苗计划，以适应不同的国家背景和人群，从而实现最佳实施和影响。此外，本综述强调了关于新型和重新利用的结核病疫苗在潜在受益人群中的可接受性及其接种方面、最有前景的实施策略以及实施所需的卫生系统能力的研究稀缺。这些领域缺乏此类知识凸显了未来研究的迫切需求，以确保在全球高负担地区有效实施结核病疫苗。
