HIC-Vac Network additional funding

英国是通过人体实验进行原创科学发现的全球领导者。志愿者的人类感染挑战具有风险，但这些风险需要与能够在实验中测试疫苗和治疗方法而无需等待人们自然感染的巨大优势相平衡。尽管疫苗每年在地球仪上挽救了数百万人的生命，但仍有许多传染病仍无法通过疫苗接种预防，导致大量人死亡。在低收入和中等收入国家尤其如此，在这些国家，甚至连基本的医院治疗都无法获得，唯一现实的选择是通过寻找新的和经济上可行的疫苗来预防传染病。这一目标的核心是与这些中低收入国家的科学家密切合作，他们可以向监管机构、政策制定者和公众宣传这些研究的价值。开发一种新疫苗过去需要20年时间，成本超过10亿英镑。这种情况在COVID大流行期间发生了变化，但通过使用实验挑战，可以更快地获得明确的结果，显示疫苗是否有效，只需少数志愿者-可能10至100人-接种疫苗，并给予类似数量的对照接种。以这种方式进行攻毒研究，原则上可以证明疫苗的有效性。相比之下，证明疫苗有效所需的实地研究规模可能很大，通常涉及数千人，成本比人体挑战研究高出许多倍。从伦理上讲，人体挑战的好处需要仔细权衡可能对志愿者造成的伤害。这就缩小了可以检测的感染范围，只限于那些疾病相对较轻或可预测和自限性的感染，或者可以通过现有药物或支持性护理轻松可靠地治疗的感染。联合王国正在进行的人类感染研究包括流感、呼吸道合胞病毒、鼻病毒、伤寒和副伤寒、疟疾、细菌性肺炎和百日咳。尽管还有一些问题需要克服，但如果能够进行人体挑战，将大大加快新出现的病毒（如寨卡病毒、登革热和MERS）的疫苗开发。疫苗领域正处于一个非常令人兴奋的阶段，因为早期研究中出现的许多免疫学概念现在可以应用于新的情况。目前，英国（伦敦、牛津、利物浦、约克、诺丁汉和南安普顿）和海外的E-Vac联盟成员在开展这些研究时面临许多伦理和监管挑战，他们渴望分享经验并提供相互支持。我们不仅在实验技术方面，而且在如何克服监管和安全工作实践的巨大但必要的负担方面，都有很多东西可以相互学习。为此，我们将共同努力：定期举行电话会议、面对面会议和相互提供实际支持。Vac的主要优势是我们可以将资金分配给成员，从而使这项工作成为可能。除了加速疫苗开发，我们的网络将合作解决有关人类感染的基本科学问题，这些问题只能从英国和全球（特别是LMIC地区）的挑战研究中获得。

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).