Henry M Jackson Foundation for the Advancement of Military Medicine, USA.
Vaccine. 2011 Jun 24;29(29-30):4647-53. doi: 10.1016/j.vaccine.2011.04.035. Epub 2011 May 14.
Although clinical trials are the ultimate way to prove vaccine safety and efficacy, the complexity, cost and time required to develop a product to enter human trials demand a serious, long-term investment. Lack of knowledge on immune correlates of protection from HIV infections makes investments in HIV vaccine research significantly risky. Preclinical testing of HIV vaccines is routinely carried out in non-human primate models however these studies have a significant cost and their predictive value is still questionable. The potential value of screening new HIV-1 vaccine candidates on human cells and tissues via high throughput in vitro systems that allow rapid, cost-effective and accurate predictions of in vivo immune responses would be enormous. A one-day workshop was convened by Division of AIDS, National Institutes of Health on August 4, 2010 to address the benefits and challenges of assessing HIV-1 vaccine responses in alternative ways. Consideration was given to the use of various in vitro model systems, human mucosal tissue explants and humanized mouse models as ways to predict immunogenicity and efficacy of HIV-1 vaccines early in the development process, and support decisions on whether a product may be worthy of moving into non-human primates or human trials. This report summarizes the outcome of the workshop.
虽然临床试验是证明疫苗安全性和有效性的最终手段，但开发一种进入人体试验的产品所需的复杂性、成本和时间要求对其进行认真、长期的投资。由于缺乏对 HIV 感染免疫保护相关因素的了解，HIV 疫苗研究的投资风险显著增加。HIV 疫苗的临床前测试通常在非人类灵长类动物模型中进行，但这些研究成本高昂，其预测价值仍存在疑问。通过高通量体外系统筛选新的 HIV-1 疫苗候选物，对人类细胞和组织进行快速、经济高效和准确的体内免疫反应预测，其潜在价值巨大。美国国立卫生研究院艾滋病司于 2010 年 8 月 4 日召开了为期一天的研讨会，讨论了以替代方式评估 HIV-1 疫苗反应的益处和挑战。会议考虑了使用各种体外模型系统、人黏膜组织外植体和人源化小鼠模型来预测 HIV-1 疫苗在开发过程早期的免疫原性和疗效，并支持关于是否值得将产品推进到非人类灵长类动物或人体试验的决策。本报告总结了研讨会的成果。
