MICA: Ad4HIV, A Phase I Trial Investigating Ad4, MVA and Protein Immunisation Strategies to Maximise Protective Antibody Responses to HIV-1 Envelope

MICA：Ad4HIV，一项 I 期试验，研究 Ad4、MVA 和蛋白质免疫策略，以最大限度地提高对 HIV-1 包膜的保护性抗体反应

• 批准号: MR/M015750/1
• 负责人: Robin Shattock
• 金额: $ 119.65万
• 依托单位: Imperial College London
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2015
• 资助国家: 英国
• 起止时间: 2015 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FM015750%2F1
• 关键词: MICA; Ad4HIV; Phase; Trial; Investigating

The global health burden associated with HIV continues to grow with 35 million people estimated to be living with HIV in 2013 and 2.3 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, clinical, and technical 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 an industrial partner, PaxVax, and the UK HIV Vaccines Consortium (UK HVC). PaxVax is a fully integrated vaccine company, whose founders set out to develop and commercialize an innovative vaccine technology in a socially responsible manner for global impact. The UK HVC is a Wellcome Trust funded programme 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 Ad4HIV trial is based on an immunisation regimen similar to that used in the only HIV vaccine trial to demonstrate partial efficacy (RV144, which showed an initial 60% reduction in infection rapidly waning to 31% in Thailand) and which builds on an existing MRC DCS funded study (UK HVC Spoke 003) to which it will be comparable. The Ad4HIV study will explore both the safety and immunogenicity of a novel combination of HIV vaccine candidates and will formally explore the immunological impact of a shorter and simpler prime-boost strategy using vaccine candidates provided by the UK HVC and designed to induce sustainable levels of protection form HIV acquisition of more than 60%. It will also explore the effectiveness of different boosting strategies with the added advantage of simplifying 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.

与艾滋病毒相关的全球健康负担继续增长，估计在2013年患有艾滋病毒和230万新感染的3500万人。在缺乏治疗的情况下，有效的疫苗将是防止新艾滋病毒感染的最可持续方法。我们建议从一系列以前的疫苗试验中获得的知识来设计和测试艾滋病毒疫苗策略，我们认为，我们认为，与迄今为止观察到的疫苗和疫苗策略相比，我们将触发更好的免疫反应，并可能导致识别成功的疫苗和疫苗策略。该提案围绕着围绕科学，临床和技术供应范围的hiv范围来融合了众多的疫苗，并汇集了一系列的hiv，这是一个常见的hiv，这是一个常见的hiv，这是一个普通的hiv范围。和尼泊尔，这引起了世界上最严重的艾滋病毒流行病，并造成了所有感染的一半。该研究将与工业合作伙伴Paxvax和英国HIV疫苗联盟（英国HVC）合作进行。 Paxvax是一家完全集成的疫苗公司，其创始人着手以对全球影响的社会负责的方式开发和商业化创新的疫苗技术。英国HVC是一项由惠康信托资助的计划，其使命是生成一系列含有类似HIV抗原的候选疫苗，因此可以进行直接比较，以最快地了解人类免疫的最快免疫原性策略。AD4HIV的设计基于AD4HIV试验的设计，基于一种与HIV的疫苗相似的免疫试验，该试验与HIV疫苗相似，以表现为HIV 1的初始试验，以表现为HIV的初始试验，该试验的初步性试验是40％的效果。4泰国的感染迅速降低至31％），并建立在现有的MRC DCS资助研究（英国HVC Spoke 003）上，这将是可比的。 AD4HIV研究将探索HIV疫苗候选物的新型组合的安全性和免疫原性，并将正式探索使用英国HVC提供的疫苗候选者的较短和简单的Prime-Trakit策略的免疫学影响，并旨在诱导可持续的60％以上保护型艾滋病毒艾滋病毒的艾滋病毒。它还将探索不同的增强策略的有效性，并具有简化对疫苗可行性至关重要的方案的额外优势。成功且安全的HIV疫苗将在整个一般人群和高风险群体中具有可观的好处。它可能有可能在15年的时间内预防超过7,000万种感染。如果试验确定了有希望的疫苗结构或策略，则该研究将支持下一项临床研究的设计，并为预防艾滋病毒的多个领域提供了信息和支持决策和政策制定的机会。