Aggerbeck H, Heron I
Statens Seruminstitut, Bacterial Vaccine Department, Copenhagen, Denmark.
Vaccine. 1995 Oct;13(14):1360-5. doi: 10.1016/0264-410x(94)00081-w.
The potencies of two diphtheria-tetanus vaccines (DT) adsorbed to either aluminium hydroxide or calcium phosphate were compared in mice and guinea pigs. The vaccines were made from the same batches of purified toxoids and contained the same amounts of antigens. Immunizations were done once or twice with different doses of vaccine injected undiluted, diluted in saline or diluted in the corresponding adjuvant. The various potency assays showed that the adjuvanticity of calcium phosphate was lower than or equal to aluminium hydroxide. Despite the range of potency assays done, none of the methods reflected the efficacy of these vaccines in revaccination of humans. A simplified potency assay is suggested for release of final vaccine formulations to reduce the number of animals in quality control.
在小鼠和豚鼠中比较了两种吸附于氢氧化铝或磷酸钙的白喉-破伤风疫苗（DT）的效力。这些疫苗由同一批次的纯化类毒素制成，含有相同量的抗原。使用不同剂量的疫苗进行一次或两次免疫接种，疫苗未稀释、用生理盐水稀释或用相应佐剂稀释后注射。各种效力测定表明，磷酸钙的佐剂活性低于或等于氢氧化铝。尽管进行了一系列效力测定，但没有一种方法能反映这些疫苗在人类再接种中的效果。建议采用一种简化的效力测定方法来放行最终疫苗制剂，以减少质量控制中动物的使用数量。
