Developmental Clinical Study - UK HVC 003 DMP Phase I Prime-Boost-ReBoost HIV vaccine trial

与艾滋病毒有关的全球健康负担继续增加，2009年估计有3300万艾滋病毒携带者和270万新感染者。在没有治愈方法的情况下，有效的疫苗将是预防新的艾滋病毒感染的最可持续的方式。我们建议最大限度地利用我们从以前的一系列疫苗试验中学到的知识来设计和测试艾滋病毒疫苗策略，我们相信这种策略将引发比迄今观察到的更好的免疫反应，并可能导致确定成功的疫苗和疫苗策略。该方案汇集了科学专业知识和一系列疫苗产品，这些产品是围绕一种常见的艾滋病毒设计的，这种病毒主要在南部和东非、印度和尼泊尔发现，这种病毒已经导致了世界上最严重的艾滋病毒流行，约占所有感染病例的一半。这项研究将与英国艾滋病毒疫苗联盟(UK HVC)合作进行，该联盟的任务是生产一系列含有类似HIV抗原的候选疫苗，以便能够实现直接比较，以最快地了解人类最具免疫原性的免疫策略。英国HVC 001DMP试验的设计基于一种类似于唯一展示部分疗效的艾滋病毒疫苗试验中使用的免疫方案(RV144，显示泰国艾滋病毒感染减少了31%)。这项研究将探索这种新型候选艾滋病毒疫苗组合的安全性和免疫原性，并将正式探索使用英国HVC提供的不同候选疫苗的最佳、增强和再增强策略的免疫学影响。它还将探索将候选疫苗结合在一起的有效性，以及将被视为对疫苗可行性至关重要的方案长度降至最低的额外优势。一种成功和安全的艾滋病毒疫苗将对普通人群和高危人群产生相当大的好处。它有可能在15年内预防7000多万人感染。如果试验确定了有前景的疫苗结构或策略，研究将支持下一步临床研究的设计，并提供机会，为艾滋病毒预防的几个领域的决策和政策制定提供信息和支持。

The global health burden associated with HIV continues to grow with 33 million people estimated to be living with HIV in 2009 and 2.7 million new infections. In absence of a cure, an effective vaccine would be the most sustainable way to prevent new HIV infections. We propose to make the most of what we have learned from a series of previous vaccine trials to design and test an HIV vaccine strategy which we believe will trigger a better immune response than those observed so far and potentially lead to the identification of a successful vaccine and vaccine strategy.The proposal brings together the scientific expertise and a range of vaccine products that are designed around a common HIV virus found predominantly in Southern and East Africa, India and Nepal and which has caused the world s worst HIV epidemics and is responsible for around half of all infections. The study will be conducted in collaboration with the UK HIV Vaccines Consortium (UK HVC) whose mission is to generate a series of candidate vaccines containing similar HIV antigens, such that direct comparison can be achieved to understand most rapidly the most immunogenic strategy for immunization in man.The design of the UK HVC 001DMP trial is based on an immunisation regimen similar to that used in the only HIV vaccine trial to demonstrate partial efficacy (RV144, which showed a 31% reduction in HIV infection in Thailand). The study will explore both the safety and immunogenicity of this novel combination of HIV vaccine candidates and will formally explore the immunological impact of a prime, boost and re-boost strategy using different vaccine candidates provided by the UK HVC. It will also explore the effectiveness of combining vaccines candidate together with the added advantage of minimising the length of the regimen seen as crucial to vaccine feasibility.A successful and safe HIV vaccine would have considerable benefits across the general populations and high risk groups. It could have the potential to prevent over 70 million infections over the course of 15 years. Should the trial identify promising vaccine constructs or strategies, the research would support the design of the next clinical studies and provide an opportunity to inform and support decisions and policy making in several areas of HIV prevention.