Burlet E, HogenEsch H, Dunham A, Morefield G
VaxForm, LLC, Bethlehem, Pennsylvania, USA.
Department of Comparative Pathobiology, Purdue University, West Lafayette, Indiana, USA.
AAPS J. 2017 May;19(3):875-881. doi: 10.1208/s12248-017-0069-5. Epub 2017 Mar 10.
Streptococcus pyogenes or group A streptococcus (GAS) is a Gram-positive bacterium that can cause a wide range of diseases, including pharyngitis, impetigo, scarlet fever, necrotizing fasciitis, rheumatic fever, and streptococcal toxic shock syndrome. Despite the increasing burden on global health caused by GAS, there is currently no licensed vaccine available. In this study, we evaluated immunogenicity, induction of neutralizing antibodies, and stability of a new recombinant fusion protein vaccine that targets infections from GAS. The recombinant fusion protein (SpeAB) combines inactive mutant forms of streptococcal pyrogenic exotoxin A (SpeA) and streptococcal pyrogenic exotoxin B (SpeB). The SpeAB vaccine evaluated in this study was adsorbed to an aluminum adjuvant and demonstrated robust immunogenicity, eliciting production of specific neutralizing antibodies against SpeA and SpeB, two major virulence factors of S. pyogenes. Stability studies suggest that the vaccine will retain immunogenicity for at least 2 years when stored at refrigerated temperatures. This novel vaccine shows great potential to provide protection against GAS infections and to reduce the burden of GAS disease globally.
化脓性链球菌或A组链球菌（GAS）是一种革兰氏阳性细菌，可引起多种疾病，包括咽炎、脓疱病、猩红热、坏死性筋膜炎、风湿热和链球菌中毒性休克综合征。尽管GAS给全球健康带来的负担日益加重，但目前尚无获批的疫苗。在本研究中，我们评估了一种针对GAS感染的新型重组融合蛋白疫苗的免疫原性、中和抗体诱导情况及稳定性。重组融合蛋白（SpeAB）结合了无活性的突变形式的链球菌致热外毒素A（SpeA）和链球菌致热外毒素B（SpeB）。本研究中评估的SpeAB疫苗吸附于铝佐剂，表现出强大的免疫原性，可诱导产生针对化脓性链球菌的两种主要毒力因子SpeA和SpeB的特异性中和抗体。稳定性研究表明，该疫苗在冷藏温度下储存时至少2年内仍将保持免疫原性。这种新型疫苗在提供针对GAS感染的保护及减轻全球GAS疾病负担方面显示出巨大潜力。
