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[用于不同年龄段儿童免疫的脑膜炎球菌化学多价ABC疫苗的最佳接种剂量。II. 不同剂量制剂的免疫效果研究]

[Optimal inoculation doses of meningococcal chemical polyvalent ABC-vaccine for immunizing children of different ages. II. A study of the immunological effectiveness of different doses of the preparation].

作者信息

Ganzenko V P, Sumarokov A A, Nikonova V A, Filippov Iu V, Valcarcel Novo M

出版信息

Zh Mikrobiol Epidemiol Immunobiol. 1983 Apr(4):23-6.

PMID:6408855
Abstract

The study of meningococcal chemical polyvalent ABC-vaccine, manufactured by the Mechnikov Research Institute for Vaccines and Sera (Moscow), was carried out with the aim of finding the optimum vaccination doses for the immunization of children aged 0.5-15 years. In this study the effectiveness of the vaccine was evaluated by the determination of the titers of specific bactericidal antibodies in paired serum samples obtained before and 30 days after immunization. The analysis of the frequency of positive seroconversions and the levels of the geometric mean antibody titers allowed the authors to reveal the presence of a distinct relationship between the intensity of antibody production and the dose of the vaccine under test, used for immunization, as well as to establish that pronounced immune response to the optimum dose developed in 95-100% of the vaccinees. Taking into account the results obtained in the earlier studies of the safety and reactogenicity of the preparation (see Communication I), the optimum vaccination doses for the immunization of children of different age groups were established. On the basis of the statistical analysis of the characteristics of immune response to different doses of the preparation the following doses were chosen as optimum: 80 micrograms for children aged 0.5-2 years, 100 micrograms for children aged 3-7 years, 120 micrograms for children aged 8-11 years, 160 micrograms for children aged 12-15 years.

摘要

对由梅契尼科夫疫苗和血清研究所(莫斯科)生产的脑膜炎球菌化学多价ABC疫苗进行了研究,目的是找出0.5至15岁儿童免疫接种的最佳疫苗剂量。在这项研究中,通过测定免疫接种前和接种后30天采集的配对血清样本中特异性杀菌抗体的滴度来评估疫苗的有效性。对阳性血清转化频率和几何平均抗体滴度水平的分析使作者能够揭示抗体产生强度与用于免疫接种的受试疫苗剂量之间存在明显关系,并确定95%至100%的接种者对最佳剂量产生了明显的免疫反应。考虑到该制剂早期安全性和反应原性研究的结果(见通讯I),确定了不同年龄组儿童免疫接种的最佳疫苗剂量。基于对不同剂量制剂免疫反应特征的统计分析,选择了以下最佳剂量:0.5至2岁儿童为80微克,3至7岁儿童为100微克,8至11岁儿童为120微克,12至15岁儿童为160微克。

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