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HIV immunoprophylaxis: preparing the pathway from proof of concept to policy decision and use.
The Lancet HIV ( IF 12.8 ) Pub Date : 2019-11-27 , DOI: 10.1016/s2352-3018(19)30294-2
Johan Vekemans 1 , William Snow 1 , Patricia E Fast 2 , Rachel Baggaley 1 , Kundai Chinyenze 3 , Martin H Friede 1 , Peter Godfrey-Faussett 4 , David C Kaslow 5 , Helen Rees 6
Affiliation  

Various long-awaited efficacy studies of vaccines and broadly neutralising antibodies for prevention of HIV are now well underway in highly endemic settings. One broadly neutralising monoclonal antibody is being assessed for proof of concept, and combinations are in the pipeline. Two multicomponent prime-and-boost vaccine regimens are being evaluated, one of which is designed for global coverage. These multicomponent vaccines present a new level of complexity that will challenge health delivery systems. We recommend that while awaiting the results, which will appear in 2020–22, the target product profiles and full public value proposition for both categories of products should be defined, and the regulatory, policy, and implementation pathways should be prepared. Economic and health benefits, cost of goods, administrative complexity, and user perspectives will be key considerations for the roll-out of effective products. Investments in manufacturing capacity and public-sector delivery systems will be needed to prepare for product introduction and scale-up. We propose a prioritisation of activities on the basis of a broad stakeholder consultation organised by WHO and UNAIDS.



中文翻译:

HIV免疫预防:准备从概念验证到政策决策和使用的途径。

在高度流行的环境中,疫苗和广泛中和的抗体用于预防HIV的各种期待已久的功效研究目前正在进行中。正在评估一种广泛中和的单克隆抗体的概念验证,并且正在酝酿中进行组合。正在评估两种多组分初免疫苗方案,其中一种是为全球覆盖而设计的。这些多组分疫苗将复杂性提高到一个新水平,这将挑战健康提供系统。我们建议在等待将在2020-22年间出现的结果的同时,应定义两类产品的目标产品概况和完整的公共价值主张,并应制定监管,政策和实施途径。经济和健康利益,商品成本,行政管理的复杂性,用户角度将是推出有效产品的关键考虑因素。将需要在制造能力和公共部门交付系统上进行投资,以为产品推出和扩大规模做准备。我们建议在世卫组织和艾滋病规划署组织的利益攸关方广泛协商的基础上,对活动进行优先排序。

更新日期:2019-11-27
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