HIC-Vac Network additional funding

HIC-Vac 网络额外资金

• 批准号: MR/Y033736/1
• 负责人: Peter Openshaw
• 金额: $ 166.57万
• 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: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FY033736%2F1
• 关键词: HIC; Vac; Network; additional; funding

The UK is a global leader in making original scientific discoveries by human experimentation. Human infection challenge of volunteers carries risks, but these need to be balanced against the great advantage of being able to test vaccines and treatments experimentally without waiting for people to be naturally infected. Although vaccines save millions of lives around the globe every year, there are many infectious diseases that still kill large numbers of people that are still not preventable by vaccination. This is especially true in low and middle income countries (LMIC) where even basic hospital treatment is unavailable and the only realistic option is to prevent infectious diseases by finding new and economically viable vaccines. Central to this aim is close collaboration with scientists in these LMICs, who can advocate for the value of these studies with regulators, policy makers and the public.Developing a new vaccine used to take 20 years and cost over £1bn. This situation has changed during the COVID pandemic but, by using experimental challenge, definitive results can be obtained much quicker showing that a vaccine works or does not work with only a few volunteers - perhaps 10 to 100 - being given the vaccine and a similar number being given control inoculation. Conducting challenge studies in this way allows proof in principle of vaccine efficacy. By contrast, the field studies that are needed to prove that a vaccine works can be vast, usually involving thousands of individuals and costing many times more than a human challenge study.Ethically, the benefits of human challenge need to be weighed carefully against the harm that may be caused to the volunteers. This narrows the range of infections that can be tested to those where the disease is relatively mild or predictable and self-limiting, or diseases that can be easily and reliably treated by existing drugs or supportive care. Examples of human infection studies that are on-going in the United Kingdom include Influenza, RSV, rhinovirus, typhoid and paratyphoid, malaria, bacterial pneumonia and whooping cough. Although there are problems to be overcome, vaccine development for emerging viruses such as Zika, dengue and MERS would be greatly accelerated if human challenge could be performed.The field of vaccines is in a very exciting stage in that many immunological concepts that have emerged from earlier studies can now been applied in fresh situations. At present the members of the HIC-Vac consortium in the UK (London, Oxford, Liverpool, York, Nottingham and Southampton) and overseas have faced many ethical and regulatory challenges to mounting these studies and are keen to share their experience and to provide mutual support. We have a great deal to learn from one another regarding not only experimental techniques but also how to overcome the large but necessary burden of regulation and safe working practices. We will do this by bringing our efforts together: holding regular meetings by phone, face to face and providing one another with practical support. HIC-Vac's main strength is that we can distribute funding to members, so enabling this work. In addition to accelerating vaccine development, our Network will collaborate in addressing fundamental scientific questions about human infection that can only be obtained from challenge studies both within the UK and globally (especially LMIC regions).

英国是通过人类实验做出原始科学发现的全球领导者。志愿者的人类感染挑战会带来风险，但是这些挑战必须与能够在实验上测试疫苗和治疗的巨大优势，而无需等待人们自然感染。尽管疫苗每年挽救全球数百万次生命，但仍有许多传染病仍然杀死大量仍无法通过疫苗预防的人。在低收入国家（LMIC）中尤其如此，即使基本的医院治疗也无法获得，唯一现实的选择是通过寻找新的且经济上可行的疫苗来预防传染病。这个目标的核心是与这些LMIC的科学家密切合作，他们可以主张与监管机构，政策制定者和公众进行这些研究的价值。开发一种新的疫苗，用于花费20年，费用超过10亿英镑。这种情况在联想大流行期间发生了变化，但是，通过使用实验挑战，可以更快地获得确定的结果，表明疫苗可以起作用，或者仅与少数几个志愿者（也许10至100）起作用（也许是10至100），并给予了疫苗和类似的数量。以这种方式进行挑战研究可以原则上的疫苗效率证明。相比之下，证明疫苗工作可能是巨大的，通常涉及成千上万的人，比人类挑战研究的成本多得多。从人类的挑战研究中，人类挑战的好处需要仔细权衡，以应对对志愿者造成的伤害。这范围缩小了可以对疾病相对轻度或可预测且自我限制的感染范围，或者可以通过现有药物或支持的护理来可靠治疗的疾病。英国正在进行的人类感染研究的例子包括流感，RSV，鼻病毒，伤寒和副肌，疟疾，细菌性肺炎和百日咳。尽管有问题要克服，但如果可以执行人类挑战，Zika，Dengue和Mers等新兴病毒的疫苗开发将大大加速。疫苗领域处于一个非常令人兴奋的阶段，因为现在可以在新的情况下应用了许多早期研究的免疫学概念。目前，英国HIC-VAC财团的成员（伦敦，牛津，利物浦，约克，诺丁汉和南安普敦）和海外的成员面临许多道德和监管挑战，以实现这些研究，并热衷于分享他们的经验并提供共同的支持。我们有很多关于不仅实验技术的知识，而且还可以学习如何克服规定和安全的工作实践的大量但必要的燃烧。我们将通过将我们的努力汇集在一起​​来做到这一点：通过电话，面对面举行定期会议，并互相提供实际支持。 HIC-VAC的主要优势是我们可以向会员分配资金，因此可以实现这项工作。除了加速疫苗开发外，我们的网络还将合作解决有关人类感染的基本科学问题，这只能从英国和全球范围内的挑战研究（尤其是LMIC地区）中获得。