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新型和重新利用的结核病疫苗的潜在实施策略、可接受性和可行性。

Potential implementation strategies, acceptability, and feasibility of new and repurposed TB vaccines.

作者信息

Pelzer Puck T, Seeley Janet, Sun Fiona Yueqian, Tameris Michele, Tao Li, Yanlin Zhao, Moosan Hisham, Weerasuriya Chathika, Asaria Miqdad, Jayawardana Sahan, White Richard G, Harris Rebecca C

机构信息

KNCV Tuberculosis Foundation, Amsterdam, Netherlands.

London School of Hygiene & Tropical Medicine (LSHTM), London, United Kingdom.

出版信息

PLOS Glob Public Health. 2022 May 3;2(5):e0000076. doi: 10.1371/journal.pgph.0000076. eCollection 2022.

Abstract

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.

摘要

最近,两项2B期结核病疫苗试验报告了在青少年和成人中的阳性疗效结果。然而,为这些年龄组接种疫苗的经验有限。我们确定了M72/AS01E疫苗接种和卡介苗再接种类似候选疫苗的潜在实施策略,并探讨了它们的可接受性和可行性。我们对关键决策者进行了深入的半结构化访谈,以确定南非、印度和中国的实施策略和目标群体。使用编码框架进行主题和演绎分析,以确定不同环境和同一环境中的主题。在所有三个国家,人们对新型结核病疫苗都感兴趣,在校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。由于针对性大规模接种运动存在耻辱感和后勤问题,所有国家都倾向于常规接种。实施M72/AS01E疫苗的预期益处是对结核分枝杆菌(Mtb)感染者可能有效,以及对艾滋病毒感染者有效。M72/AS01E疫苗面临的挑战包括基础设施和所需的两剂接种方案。利益相关者重视卡介苗的熟悉度,但担心其对艾滋病毒感染者的不良反应,这在南非是一个特别令人担忧的问题。在所有三个国家都确定了实施方面的挑战和机遇。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。确定了这些环境中疫苗实施的关键群体,应将其纳入临床试验和实施规划。

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