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四种b型流感嗜血杆菌结合疫苗在芬兰24月龄儿童中的免疫原性和反应原性

Immunogenicity and reactogenicity of four Haemophilus influenzae type b capsular polysaccharide vaccines in Finnish 24-month-old children.

作者信息

Käyhty H, Peltola H, Eskola J

机构信息

National Public Health Institute, Helsinki, Finland.

出版信息

Pediatr Infect Dis J. 1988 Aug;7(8):574-7.

PMID:3050853
Abstract

Stimulated by questions raised on potential differences between the Haemophilus influenzae type b capsular polysaccharide (PRP) vaccines on the market and the applicability of the efficacy data of a similar PRP vaccine obtained in a large field study in 1974 in Finland, we wished to compare the immunogenicity of all these preparations in 24-month-old Finnish children. In our study 137 children received the now recommended 25-micrograms dose of 1 of 4 H. influenzae type b PRP vaccines currently available, and an additional 86 children received half this dose corresponding to the 12.7 micrograms used in 1974. Anti-PRP antibodies were measured in blood samples taken before and 4 weeks after vaccination by the same radioimmunoassay and in the same laboratory as in 1974. The vaccines were equally immunogenic. Furthermore the now recommended dose of 25 micrograms did not give results (geometric mean concentrations, 2.38 to 3.45 micrograms/ml) differing from those after a 12.5-micrograms (2.01- to 3.45-micrograms/ml) dose which was used in 1974. Antibody concentrations of 0.15 and 1.0 micrograms/ml were achieved in 91 to 95 and 66 to 84% of the children, respectively. The corresponding values after 1974 vaccinations were 3.53 micrograms/ml and 100 and 82% of children, respectively. The percentage of those responding with concentrations greater than or equal to 1 microgram/ml was somewhat higher in these Finnish children than reported for children of the same age receiving the same vaccine lots in the United States. Adverse reactions were mild or moderate and transient.

摘要

受到有关市场上b型流感嗜血杆菌荚膜多糖(PRP)疫苗之间潜在差异以及1974年在芬兰进行的一项大型现场研究中获得的类似PRP疫苗疗效数据适用性问题的启发,我们希望比较所有这些制剂在24个月大的芬兰儿童中的免疫原性。在我们的研究中,137名儿童接受了目前推荐的25微克剂量的4种现有b型流感嗜血杆菌PRP疫苗中的1种,另外86名儿童接受了该剂量的一半,即1974年使用的12.7微克剂量。通过与1974年相同的放射免疫测定法并在同一实验室中,在接种疫苗前和接种后4周采集的血样中测量抗PRP抗体。这些疫苗具有同等的免疫原性。此外,目前推荐的25微克剂量所产生的结果(几何平均浓度为2.38至3.45微克/毫升)与1974年使用的12.5微克(2.01至3.45微克/毫升)剂量后的结果并无差异。分别有91%至95%和66%至84%的儿童抗体浓度达到0.15微克/毫升和1.0微克/毫升。1974年接种疫苗后的相应值分别为3.53微克/毫升以及100%和82%的儿童。这些芬兰儿童中抗体浓度大于或等于1微克/毫升的反应百分比略高于在美国接受相同疫苗批次的同龄儿童的报告值。不良反应为轻度或中度且短暂。

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