动物模型有助于以相对较低的成本评估疫苗功效。这项研究是对新型13价肺炎球菌结合疫苗(PCV13)与对照疫苗在小鼠模型中的免疫原性和保护功效的比较评估。接种疫苗后,通过肺炎球菌多糖(PnP)酶联免疫吸附试验(ELISA)和调理吞噬杀伤试验(OPA)评估抗荚膜抗体水平。此外,小鼠腹腔内攻击50%致死剂量的100倍肺炎链球菌.针对血清型1、4、7F的抗荚膜IgG水平,14,18C,19A,19F很高(四分位数2>1600),而针对其他血清型的低(Q2≤800)。此外,OPA滴度与PnPELISA测定相似。在小鼠模型中,新型PCV13和对照疫苗接种组之间的比较分析显示,几种血清型的血清学免疫和群体中抗荚膜IgG的范围存在显着差异。用血清型3,5,6A攻击野生型或中性粒细胞减少小鼠,6B,尽管诱导的抗荚膜抗体水平相对较低,但9V仍显示出保护性免疫。通过比较分析,作为临床前试验,小鼠模型应该足以评估血清学疗效和人群水平的差异。
Animal models facilitate evaluation of vaccine efficacy at relatively low cost. This study was a comparative evaluation of the immunogenicity and protective efficacy of a new 13-valent pneumococcal conjugate vaccine (PCV13) with a control vaccine in a mouse model. After vaccination, anti-capsular antibody levels were evaluated by pneumococcal polysaccharide (PnP) enzyme-linked immunosorbent assay (ELISA) and opsonophagocytic killing assay (OPA). Also, mice were challenged intraperitoneally with 100-fold of the 50% lethal dose of Streptococcus pneumoniae. The anti-capsular IgG levels against serotypes 1, 4, 7F, 14, 18C, 19A, and 19F were high (quartile 2 >1,600), while those against the other serotypes were low (Q2 ≤ 800). Also, the OPA titres were similar to those determined by PnP ELISA. Comparative analysis between new PCV13 and control vaccination group in a mouse model exhibited significant differences in serological immunity of a few serotypes and the range of anti-capsular IgG in the population. Challenge of wild-type or neutropenic mice with serotypes 3, 5, 6A, 6B, and 9V showed protective immunity despite of induced relatively low levels of anti-capsular antibodies. With comparison analysis, a mouse model should be adequate for evaluating serological efficacy and difference in the population level as preclinical trial.