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一项针对9至23个月大儿童的随机双盲临床试验,比较用17DD和17D - 213/77亚株制备的两种黄热病疫苗。

A randomised double-blind clinical trial of two yellow fever vaccines prepared with substrains 17DD and 17D-213/77 in children nine-23 months old.

出版信息

Mem Inst Oswaldo Cruz. 2015 Sep;110(6):771-80. doi: 10.1590/0074-02760150176.

Abstract

This randomised, double-blind, multicentre study with children nine-23 months old evaluated the immunogenicity of yellow fever (YF) vaccines prepared with substrains 17DD and 17D-213/77. YF antibodies were titered before and 30 or more days after vaccination. Seropositivity and seroconversion were analysed according to the maternal serological status and the collaborating centre. A total of 1,966 children were randomised in the municipalities of the states of Mato Grosso do Sul, Minas Gerais and São Paulo and blood samples were collected from 1,714 mothers. Seropositivity was observed in 78.6% of mothers and 8.9% of children before vaccination. After vaccination, seropositivity rates of 81.9% and 83.2%, seroconversion rates of 84.8% and 85.8% and rates of a four-fold increase over the pre-vaccination titre of 77.6% and 81.8% were observed in the 17D-213/77 and 17DD subgroups, respectively. There was no association with maternal immunity. Among children aged 12 months or older, the seroconversion rates of 69% were associated with concomitant vaccination against measles, mumps and rubella. The data were not conclusive regarding the interference of maternal immunity in the immune response to the YF vaccine, but they suggest interference from other vaccines. The failures in seroconversion after vaccination support the recommendation of a booster dose in children within 10 years of the first dose.

摘要

这项针对9至23个月大儿童的随机、双盲、多中心研究评估了用17DD和17D - 213/77亚株制备的黄热病(YF)疫苗的免疫原性。在接种疫苗前和接种后30天或更长时间对YF抗体进行了滴定。根据母亲的血清学状态和合作中心分析了血清阳性率和血清转化率。共有1966名儿童在南马托格罗索州、米纳斯吉拉斯州和圣保罗州的各市被随机分组,并从1714名母亲那里采集了血样。接种疫苗前,78.6%的母亲和8.9%的儿童呈血清阳性。接种疫苗后,17D - 213/77和17DD亚组的血清阳性率分别为81.9%和83.2%,血清转化率分别为84.8%和85.8%,接种后滴度比接种前增加四倍的比例分别为77.6%和81.8%。这与母亲的免疫力无关。在12个月及以上的儿童中,69%的血清转化率与同时接种麻疹、腮腺炎和风疹疫苗有关。关于母亲免疫力对YF疫苗免疫反应的干扰,数据尚无定论,但提示来自其他疫苗的干扰。接种疫苗后血清转化失败支持了在首次接种后10年内对儿童进行加强剂量接种的建议。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e46/4667580/852226cdc061/0074-0276-mioc-110-6-0771-gf01.jpg

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