Ferrantelli Flavia, Buttò Stefano, Cafaro Aurelio, Wahren Britta, Ensoli Barbara
National AIDS Center, Istituto Superiore di Sanità, V. le Regina Elena 299, 00161, Rome, Italy.
Springer Semin Immunopathol. 2006 Nov;28(3):289-301. doi: 10.1007/s00281-006-0026-3. Epub 2006 Sep 16.
The need for an effective HIV/AIDS vaccine is imperative to halt a pandemic that involves more than 40 million individuals worldwide as of 2005 and is causing enormous socio-economic losses, especially in developing countries (DC). The overall failure of more than two decades of HIV vaccine research justifies the demands for a concerted effort for the rapid development of new and efficacious vaccines against HIV/AIDS. In this context, building international collaborative networks is a must for speeding up scientific research and optimizing the use of funding in a synergistic fashion, as resources for HIV/AIDS are limited and do not involve most of the biggest Pharmas that are more interested in drug discovery. The AIDS Vaccine Integrated Project (AVIP) consortium is an example of synergistic partnership of international European Union and DC experts with a common research goal. AVIP is a European Commission-funded (FP-6), consortium-based, 5-year program directed to the fast development of new HIV/AIDS vaccine candidates to be tested in phase I clinical trials in Europe for future advancement to phase II/III testing in DC. To ensure their rapid development, AVIP novel combined vaccines include both regulatory and structural HIV antigens, which have already been tested, as single components, in phase I clinical trials. In particular, such combination vaccines may be superior to earlier vaccine candidates, the vast majority of which are based only on either structural or regulatory HIV products. In fact, the generation of immune responses to both types of viral antigens expressed either early (regulatory products) or late (structural products) during the viral life cycle can maximize immune targeting of both primary or chronic viral infection. Further, the rational design of combined vaccines allows exploitation of immunomodulatory functions of HIV regulatory proteins, which can improve immunity against structural vaccine components. The building of the AVIP consortium and its scientific strategy will be reviewed in this paper as an example of the establishment of a consortium regulated by a specific intellectual property agreement.
迫切需要一种有效的艾滋病毒/艾滋病疫苗,以遏制这一全球大流行疾病。截至2005年,全球有超过4000万人感染该病毒,它正造成巨大的社会经济损失,尤其是在发展中国家。二十多年来艾滋病毒疫苗研究的总体失败,证明了必须齐心协力快速开发新的有效艾滋病毒/艾滋病疫苗。在这种情况下,建立国际合作网络是加速科学研究并以协同方式优化资金使用的必要条件,因为用于艾滋病毒/艾滋病的资源有限,且大多数大型制药公司对此兴趣不大,它们更热衷于药物研发。艾滋病疫苗综合项目(AVIP)联盟就是欧盟与发展中国家专家为实现共同研究目标而建立的协同伙伴关系的一个范例。AVIP是一个由欧盟委员会资助(第六框架计划)、基于联盟的为期5年的项目,旨在快速开发新的艾滋病毒/艾滋病候选疫苗,在欧洲进行一期临床试验,以便未来在发展中国家推进到二期/三期试验。为确保其快速开发,AVIP新型联合疫苗包含已在一期临床试验中作为单一成分进行过测试的艾滋病毒调节和结构抗原。特别是,这种联合疫苗可能优于早期的候选疫苗,早期候选疫苗绝大多数仅基于艾滋病毒的结构或调节产物。事实上,对病毒生命周期早期(调节产物)或晚期(结构产物)表达的两种病毒抗原产生免疫反应,可使针对原发性或慢性病毒感染的免疫靶向最大化。此外,联合疫苗的合理设计能够利用艾滋病毒调节蛋白的免疫调节功能,从而增强针对结构疫苗成分的免疫力。本文将以一个由特定知识产权协议监管的联盟为例,对AVIP联盟的组建及其科学策略进行综述。