Clausi Amber, Cummiskey Jessica, Merkley Scott, Carpenter John F, Braun Latoya Jones, Randolph Theodore W
Department of Chemical and Biological Engineering, Center for Pharmaceutical Biotechnology, ECCH 111, Campus Box 424, University of Colorado, Boulder, Colorado, USA.
J Pharm Sci. 2008 Dec;97(12):5252-62. doi: 10.1002/jps.21390.
It has been suggested that agglomeration of aluminum salt adjuvant particles during freezing and drying can cause loss of immunogenicity of vaccines formulated with such adjuvants. In this study, we tested this hypothesis and examined the immune response in a murine model to various liquid, freeze-thawed, and lyophilized vaccine formulations, using lysozyme as a model antigen. The various processing techniques and excipient levels resulted in a wide range of particle size distributions (PSDs) and antigen-adjuvant binding levels. Anti-lysozyme titers were independent of the PSD for vaccines adjuvanted with either aluminum hydroxide or aluminum phosphate and also were unaffected by the level of antigen binding to the adjuvant.
有人提出，在冻干过程中铝盐佐剂颗粒的聚集会导致用这种佐剂配制的疫苗失去免疫原性。在本研究中，我们验证了这一假设，并以溶菌酶作为模型抗原，在小鼠模型中检测了对各种液体、冻融和冻干疫苗制剂的免疫反应。各种加工技术和辅料水平导致了广泛的粒径分布（PSD）和抗原-佐剂结合水平。对于用氢氧化铝或磷酸铝佐剂的疫苗，抗溶菌酶滴度与PSD无关，也不受抗原与佐剂结合水平的影响。
