Centre for Virology, University College London Medical School, United Kingdom.
J Clin Virol. 2009 Dec;46 Suppl 4:S64-7. doi: 10.1016/j.jcv.2009.10.003. Epub 2009 Oct 30.
Despite some significant challenges, there are several reasons for being optimistic about the prospect of developing vaccines against cytomegalovirus (CMV). The aim of this paper is to anticipate how positive results might be interpreted by those charged with making recommendations about universal immunisation, given that vaccines are normally expected to be highly cost-effective.
The cost effectiveness of a CMV vaccine will be assessed by means of quality adjusted life years gained, so we should design Phase III trials to capture the required evidence directly. Given a vaccine which is equally effective in all age groups at preventing primary CMV infection, immunisation of teenagers will be more cost-effective than immunisation of toddlers, because benefits which accrue in the future are discounted financially. Protection of women of childbearing age against primary infection is important, but may fail to convince sceptics because of the need to extrapolate to protection against transmission of virus to the fetus. The preference of this author is therefore to select congenital CMV infection as the primary endpoint of a Phase III study. We should also ensure that the primary endpoint of a study immunising seronegative women is congenital CMV infection in babies born to those women, not to women in general, because of the large number of babies born to seropositives.
尽管面临一些重大挑战，但人们对开发巨细胞病毒 (CMV) 疫苗仍持乐观态度，原因有几个。本文旨在预测那些负责制定普遍免疫建议的人会如何解释积极的结果，因为人们通常期望疫苗具有很高的成本效益。
CMV 疫苗的成本效益将通过获得的质量调整生命年来评估，因此我们应该设计 III 期临床试验来直接获取所需的证据。假设一种疫苗在预防原发性 CMV 感染方面在所有年龄组都同样有效，那么对青少年进行免疫接种比对幼儿进行免疫接种更具成本效益，因为未来的收益会在经济上被贴现。保护育龄妇女免受原发性感染很重要，但由于需要推断出对病毒向胎儿传播的保护作用，可能无法说服怀疑论者。因此，作者倾向于选择先天性 CMV 感染作为 III 期研究的主要终点。我们还应确保对血清阴性妇女进行免疫接种的研究的主要终点是这些妇女所生婴儿的先天性 CMV 感染，而不是一般妇女的感染，因为血清阳性妇女所生婴儿的数量很多。
