Potential implementation strategies, acceptability, and feasibility of new and repurposed TB vaccines.
Potential implementation strategies, acceptability, and feasibility of new and repurposed TB vaccines.
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DOI：
10.1371/journal.pgph.0000076
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发表时间：
2022
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最近，两项2B期结核病疫苗试验报告了青少年和成人的积极疗效结果。然而，为这些年龄组接种疫苗的经验有限。我们确定了M72/AS 01 E疫苗接种和BCG复种样候选人的潜在实施策略，并探讨了其可接受性和可行性。我们对南非、印度和中国的关键决策者进行了深入的半结构化访谈，以确定实施战略和目标群体。使用编码框架的主题和演绎分析被用来确定跨设置和设置内的主题。这三个国家都对新型结核病疫苗感兴趣，上学的青少年被列为可能的目标群体。在中国和印度，老年人也被确定为目标群体。在所有国家，常规疫苗接种都是首选，因为存在耻辱感和有针对性的大规模运动的后勤问题。实施M72/AS 01 E的预期受益是对结核分枝杆菌（Mtb）感染者的可能疗效和对艾滋病毒感染者的疗效。M72/AS 01 E的感知挑战包括基础设施和所需的两次给药方案。利益攸关方重视卡介苗的熟悉程度，但对它对艾滋病毒感染者的不利影响表示关切，这在南非尤其令人关切。在这三个国家都查明了执行方面的挑战和机遇。我们的研究为在特定目标群体中实施新型结核病疫苗以及国家特定的可接受性和可行性提供了关键信息。确定了在这些环境中实施疫苗的关键群体，并应将其纳入临床试验和实施计划。
Recently, two Phase 2B tuberculosis vaccine trials reported positive efficacy results in adolescents and adults. However, experience in vaccinating these age groups is limited. We identified potential implementation strategies for the M72/AS01E vaccination and BCG-revaccination-like candidates and explored their acceptability and feasibility. We conducted in-depth semi-structured interviews among key decision makers to identify implementation strategies and target groups in South Africa, India, and China. Thematic and deductive analysis using a coding framework were used to identify themes across and within settings. In all three countries there was interest in novel TB vaccines, with school-attending adolescents named as a likely target group. In China and India, older people were also identified as a target group. Routine vaccination was preferred in all countries due to stigma and logistical issues with targeted mass campaigns. Perceived benefits for implementation of M72/AS01E were the likely efficacy in individuals with Mycobacterium tuberculosis (Mtb) infection and efficacy for people living with HIV. Perceived challenges for M72/AS01E included the infrastructure and the two-dose regimen required. Stakeholders valued the familiarity of BCG but were concerned about the adverse effects in people living with HIV, a particular concern in South Africa. Implementation challenges and opportunities were identified in all three countries. Our study provides crucial information for implementing novel TB vaccines in specific target groups and on country specific acceptability and feasibility. Key groups for vaccine implementation in these settings were identified, and should be included in clinical trials and implementation planning.