| 摘要 |
The disclosure relates to a method of preparing an immunologically-active adjuvant-bound dried vaccine composition, the method comprising: combining at least one aluminum-salt adjuvant, at least one buffer system containing at least one volatile salt, at least one glass-forming agent and at least one antigen together to create a liquid vaccine formulation; freezing it to create a frozen vaccine formulation; and lyophilizing the frozen vaccine formulation in to create a dried vaccine composition. The aluminum-salt adjuvant is selected from of aluminum hydroxide, aluminum phosphate and aluminum sulfate, the volatile salt is selected from the group consisting of ammonium acetate, ammonium formate, ammonium carbonate, ammonium bicarbonate, triethylammonium acetate,triethylammonium formate, triethylammonium carbonate and the glass forming agent is selected from trehalose, sucrose, ficoll, dextran, sucrose, maltotriose, lactose, mannitol, hydroxyethyl starch, glycine, cyclodextrin, and povidone. The immunologically-active co-adjuvant may be lipid A, lipid A derivatives, monophosphoryl lipid A, chemical analogues of monophosphoryl Lipid A, CpG containing oligonucleotides, TLR-4 agonists, flagellin, flagellins derived from gram negative bacteria, TLR-5 agonists, fragments of flagellins capable of binding to TLR-5 receptors, saponins, analogues of saponins, QS-21, purified saponin fractions, ISCOMS or saponin combinations with sterols and lipids. The disclosure also relates to said vaccine composition. |
