Madhi Shabir A, Whitney Cynthia G, Nohynek Hanna
University of the Witwatersrand , Department of Science and Technology, South Africa.
Vaccine. 2008 Jun 16;26 Suppl 2:B9-B15. doi: 10.1016/j.vaccine.2008.06.001.
This article discusses lessons learned from clinical trials with pneumococcal conjugate vaccines (PCVs). A review of major clinical trials investigating PCV efficacy, this article provides the context to explore challenges associated with studying pneumococcal pneumonia and vaccine efficacy, particularly related to non-bacteremic disease, serotypes, and radiograph interpretation. Throughout these clinical trials, improving the pneumonia diagnosis specificity increased vaccine efficacy estimates. Additional analysis suggests this improvement may come at a cost of detecting much less of the disease burden. The article concludes with a discussion of the potential value of C-reactive protein as an adjunctive marker in measuring PCV efficacy against non-bacteremic pneumococcal pneumonia.
本文讨论了从肺炎球菌结合疫苗（PCV）临床试验中吸取的经验教训。作为对调查PCV疗效的主要临床试验的综述，本文提供了背景信息，以探讨与研究肺炎球菌肺炎和疫苗疗效相关的挑战，特别是与非菌血症性疾病、血清型和X光片解读有关的挑战。在这些临床试验中，提高肺炎诊断的特异性提高了疫苗疗效的估计值。进一步分析表明，这种提高可能是以检测到的疾病负担大幅减少为代价的。文章最后讨论了C反应蛋白作为辅助标志物在衡量PCV对非菌血症性肺炎球菌肺炎疗效方面的潜在价值。
