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b型流感嗜血杆菌荚膜多糖疫苗的耐受性和免疫原性。对325名15至71个月大儿童的研究

[Tolerance and immunogenicity of the capsular polyoside vaccine against Haemophilus influenzae type b. A study of 325 children 15 to 71 months of age].

作者信息

Reinert P, Postel-Vinay A, Bessa E, Hessel L, Schulz D, Cadoz M

出版信息

Ann Pediatr (Paris). 1989 Jan;36(1):20-5.

PMID:2784652
Abstract

The antigenic properties of the capsule polyoside (PRP) from Haemophilus influenzae type b (Hib) are adequate to form the basis for immunization designed to prevent the severe infections caused by this organism. The tolerance and immunogenicity of a vaccine containing either 12.5 or 25 micrograms PRP were studied in 325 healthy children aged 15 to 71 months after informed consent had been obtained from the parents. Each child was given one subcutaneous injection of 0.5 ml vaccine. Antibodies against Hib were assayed before and one month after the injection. Clinical tolerance was outstanding both locally (moderate and transient pain in 13% of cases) and systematically, with only eight (2.6%) febrile reactions in excess of 38.5 degrees C within 24 hours after the injection. A very significant rise in antibody titers was seen in all age groups, but a mean titer of 1 microgram/ml was achieved only in children aged 24 months or more. No significant difference was found between the two dosages. Individual analysis showed that following immunization antibody titers reached 0.15 micrograms/ml or more in 65% of infants aged 15 to 17 months, 71% of infants aged 18 to 23 months, 80% of infants aged 24 to 30 months and 95% of children older than 30 months. Despite the inadequate immune response evidenced in the younger age groups, our results confirm that Hib infections are preventable from the age of 2 years. Our results are consistent with those recorded with a similar vaccine in Finland.

摘要

b型流感嗜血杆菌(Hib)的荚膜多糖(PRP)的抗原特性足以构成预防该病原体所致严重感染的免疫基础。在获得325名15至71个月健康儿童家长的知情同意后,研究了含12.5微克或25微克PRP疫苗的耐受性和免疫原性。每个儿童皮下注射0.5毫升疫苗。在注射前和注射后1个月检测抗Hib抗体。临床耐受性在局部(13%的病例有中度和短暂疼痛)和全身都非常好,注射后24小时内仅有8例(2.6%)发热反应超过38.5摄氏度。所有年龄组的抗体滴度均有非常显著的升高,但仅24个月及以上儿童的平均滴度达到1微克/毫升。两种剂量之间未发现显著差异。个体分析显示,免疫后,15至17个月婴儿中65%、18至23个月婴儿中71%、24至30个月婴儿中80%以及30个月以上儿童中95%的抗体滴度达到0.15微克/毫升或更高。尽管在较年幼的年龄组中免疫反应不足,但我们的结果证实2岁起可预防Hib感染。我们的结果与芬兰使用类似疫苗所记录的结果一致。

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