Clarke Christopher, Bakaletz Lauren O, Ruiz-Guiñazú Javier, Borys Dorota, Mrkvan Tomas
a Department of Vaccine Research and Development, GSK Vaccines , Wavre , Belgium.
b Center for Microbial Pathogenesis , The Research Institute at Nationwide Children's Hospital , Columbus , OH , USA.
Expert Rev Vaccines. 2017 Jul;16(7):1-14. doi: 10.1080/14760584.2017.1333905. Epub 2017 Jun 7.
Protein D-containing vaccines may decrease acute otitis media (AOM) burden and nasopharyngeal carriage of non-typeable Haemophilus influenzae (NTHi). Protein D-containing pneumococcal conjugate vaccine PHiD-CV (Synflorix, GSK Vaccines) elicits robust immune responses against protein D. However, the phase III Clinical Otitis Media and PneumoniA Study (COMPAS), assessing PHiD-CV efficacy against various pneumococcal diseases, was not powered to demonstrate efficacy against NTHi; only trends of protective efficacy against NTHi AOM in children were shown. Areas covered: This review aims to consider all evidence available to date from pre-clinical and clinical phase III studies together with further evidence emerging from post-marketing studies since PHiD-CV has been introduced into routine clinical practice worldwide, to better describe the clinical utility of protein D in preventing AOM due to NTHi and its impact on NTHi nasopharyngeal carriage. Expert commentary: Protein D is an effective carrier protein in conjugate vaccines and evidence gathered from pre-clinical, clinical and observational studies suggest that it also elicits immune response that can help to reduce the burden of AOM due to NTHi. There remains a need to develop improved vaccines for prevention of NTHi disease, which could be achieved by combining protein D with other antigens.
含蛋白D的疫苗可能会减轻急性中耳炎（AOM）的负担，并减少不可分型流感嗜血杆菌（NTHi）在鼻咽部的定植。含蛋白D的肺炎球菌结合疫苗PHiD-CV（Synflorix，葛兰素史克疫苗公司）可引发针对蛋白D的强烈免疫反应。然而，评估PHiD-CV对各种肺炎球菌疾病疗效的III期临床中耳炎和肺炎研究（COMPAS），其样本量不足以证明对NTHi的疗效；仅显示了儿童中对NTHi性AOM的保护效力趋势。涵盖领域：本综述旨在综合考虑迄今为止临床前和III期临床研究的所有现有证据，以及自PHiD-CV在全球范围内引入常规临床实践以来上市后研究中出现的进一步证据，以更好地描述蛋白D在预防NTHi所致AOM中的临床效用及其对NTHi鼻咽部定植的影响。专家评论：蛋白D是结合疫苗中一种有效的载体蛋白，临床前、临床和观察性研究收集的证据表明，它还能引发免疫反应，有助于减轻NTHi所致AOM的负担。仍需要开发改进的疫苗来预防NTHi疾病，这可以通过将蛋白D与其他抗原结合来实现。
