Aggerbeck H, Heron I
Statens Seruminstitut, Bacterial Vaccine Department, Copenhagen, Denmark.
Dev Biol Stand. 1996;86:297-301.
Two diphtheria-tetanus vaccines (DT), adsorbed to either aluminium hydroxide or calcium phosphate but identical with respect to toxoid origin and amounts, were compared in full potency assays in mice according to the European Pharmacopoeia (EP) and in a reduced potency assay in guinea-pigs using a double dose immunization schedule. The efficacy of the vaccines was compared in a clinical trial with revaccination of 313 military recruits. The reduced potency assay gave a better reflection of the efficacy of the two vaccines in humans than the required assays of the EP. For release of combined, final vaccine formulations the reduced potency assay suggested will reduce the number of animals in quality control.
两种白喉破伤风疫苗（DT），一种吸附于氢氧化铝，另一种吸附于磷酸钙，但类毒素来源和含量相同，根据欧洲药典（EP）在小鼠中进行了全效测定，并在豚鼠中采用双倍剂量免疫方案进行了效价降低测定。在一项对313名新兵进行再接种的临床试验中比较了这两种疫苗的效力。与EP要求的测定相比，效价降低测定能更好地反映这两种疫苗在人体中的效力。对于组合的最终疫苗制剂的放行，建议采用的效价降低测定将减少质量控制中的动物数量。
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