Distribution of adsorbed antigen in mono-valent and combination vaccines

Distribution of adsorbed antigen in mono-valent and combination vaccines
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DOI:
10.1016/j.vaccine.2003.10.040
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发表时间:
2004-05-07
期刊:
影响因子:
5.5
通讯作者:
Hem, SL
Hem, SL
中科院分区:
医学3区
文献类型:
--
作者:
Morefield, GL;HogenEsch, H;Hem, SL

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采用荧光显微镜和流式细胞仪研究了氢氧化铝佐剂单价疫苗和联合疫苗中α-酪蛋白、牛血清白蛋白(BSA)、肌红蛋白和重组保护性抗原(rPA)的分布。绿色和红色荧光探针与抗原缀合。荧光标记的蛋白质与氢氧化铝佐剂的吸附等温线表明荧光探针的掺入不会显着影响吸附。在单价疫苗系统中,抗原吸附在一分钟内发生,并且在 1 小时内观察到佐剂聚集体的均匀表面覆盖。含量均匀性是通过混合引起的氢氧化铝佐剂聚集体的解聚集和再聚集循环来实现的。对于组合疫苗,在组合之前将两种抗原分别吸附到氢氧化铝佐剂上。组合后,由于混合而发生解聚集和重新聚集的循环,这导致两种抗原的均匀分布。这项研究的结果表明,只要遵循适当的混合程序,在单价或联合疫苗的生产过程中,含量均匀性就不会成为问题。 (C) 2003 Elsevier Ltd. 保留所有权利。
The distribution of alpha-casein, bovine serum albumin (BSA), myoglobin and recombinant protective antigen (rPA) in mono-valent and combination vaccines containing aluminum hydroxide adjuvant was studied by fluorescence microscopy and flow cytometry. Green and red fluorescent probes were conjugated to the antigens. Adsorption isotherms of the fluorescently labeled proteins to aluminum hydroxide adjuvant demonstrated that incorporation of the fluorescent probe did not significantly affect the adsorption. In mono-valent vaccine systems, antigen adsorption occurred within one minute and uniform surface coverage of the adjuvant aggregates was observed within 1 h. Content uniformity was achieved through a cycle of de-aggregation and re-aggregation of the aluminum hydroxide adjuvant aggregates caused by mixing. For combination vaccines, two antigens were adsorbed separately to the aluminum hydroxide adjuvant prior to combination. Following combination, cycles of de-aggregation and re-aggregation occurred due to mixing, which led to uniform distribution of both antigens. The results of this study indicate that content uniformity should not be an issue during the production of mono-valent or combination vaccines as long as adequate mixing procedures are followed. (C) 2003 Elsevier Ltd. All rights reserved.