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[初次水痘疫苗接种后原发性疫苗失败儿童的加强免疫接种结果]

[Results of Booster Vaccination in Children with Primary Vaccine Failure after Initial Varicella Vaccination].

作者信息

Ozakiv Takao, Nishimura Naoko, Gotoh Kensei, Funahashi Keiji, Yoshii Hironori, Okuno Yoshinobu

出版信息

Kansenshogaku Zasshi. 2016 May;90(3):291-6. doi: 10.11150/kansenshogakuzasshi.90.291.

Abstract

In October 2014, the varicella vaccination policy in Japan was changed from a single voluntary inoculation to two routine inoculations. This paper reports the results of booster vaccination in children who did not show seroconversion after initial vaccination (i.e., primary vaccine failure : PVF) over a 7-year period prior to the introduction of routine varicella vaccination. Between November 2007 and May 2014, 273 healthy children aged between 1.1 and 14.5 years (median : 1.7 years) underwent varicella vaccination. Before and 4 to 6 weeks after vaccination, the antibody titers were measured using an immune adherence hemagglutination (IAHA) assay and a glycoprotein-based enzyme-linked immunosorbent assay (gpELISA). In addition, side reactions were examined during the four-week period after vaccination. Children who did not show IAHA seroconversion (PVF) were recommended to receive a booster vaccination, and the measurement of antibody titers and an assessment of side reactions were performed after the booster dose. In May 2015, a questionnaire was mailed to each of the 273 participants to investigate whether they had developed varicella and/or herpes zoster after vaccination. After initial vaccination, the IAHA seroconversion rate was 75% and the mean antibody titer (Log2) with seroconversion was 4.7, while the gpELISA seroconversion rate was 84% and the mean antibody titer (Log10) with seroconversion was 2.4. Among children with PVF, 54 received booster vaccination within 81 to 714 days (median : 139 days) after the initial vaccination. After booster vaccination, the IAHA seroconversion rate was 98% and the mean antibody titer (Log2) with seroconversion was 5.8. Both the seroconversion rate and the antibody titer were higher compared with the values after the initial vaccination (p < 0.01). After booster vaccination, the gpELISA seropositive rate was 100% and the mean positive antibody titer (Log 10) was 3.6 ; similar results were obtained for the IAHA assay, with a significantly higher, antibody response than that after the initial vaccination (p < 0.01). Side reactions were generally minor, including fever (≥ 37.5 degrees C), rash at the injection site, and rash at other sites. There were no significant differences in the incidences of side reactions between the initial and booster vaccinations. A total of 185 participants responded to the questionnaire (response rate : 68%), and the period between receiving the initial vaccination and their response to the questionnaire ranged from 1.0 to 7.5 years (median : 4.0 years). The prevalence of breakthrough varicella after the initial vaccination was 17% among seroconverters who did not receive booster vaccination and 14% among non-seroconverters who received booster vaccination, showing no significant difference between the two groups. In conclusion, there are no safety issues regarding the administration of a booster vaccination to children with PVF after an initial varicella vaccination, and,a good antibody response can be expected.

摘要

2014年10月,日本的水痘疫苗接种政策从单次自愿接种改为两次常规接种。本文报告了在常规水痘疫苗接种引入前7年期间,初次接种后未出现血清转化的儿童(即原发性疫苗失败:PVF)的加强免疫接种结果。2007年11月至2014年5月,273名年龄在1.1至14.5岁(中位数:1.7岁)的健康儿童接受了水痘疫苗接种。在接种前以及接种后4至6周,使用免疫粘附血凝试验(IAHA)和基于糖蛋白的酶联免疫吸附试验(gpELISA)测量抗体滴度。此外,在接种后四周内检查了不良反应。未出现IAHA血清转化的儿童(PVF)被建议接受加强免疫接种,并在加强剂量后测量抗体滴度和评估不良反应。2015年5月,向273名参与者每人邮寄了一份问卷,以调查他们在接种疫苗后是否患过水痘和/或带状疱疹。初次接种后,IAHA血清转化率为75%,血清转化后的平均抗体滴度(Log2)为4.7,而gpELISA血清转化率为84%,血清转化后的平均抗体滴度(Log10)为2.4。在PVF儿童中,54名在初次接种后81至714天(中位数:139天)内接受了加强免疫接种。加强免疫接种后,IAHA血清转化率为98%,血清转化后的平均抗体滴度(Log2)为5.8。血清转化率和抗体滴度均高于初次接种后的数值(p<0.01)。加强免疫接种后,gpELISA血清阳性率为100%,平均阳性抗体滴度(Log10)为3.6;IAHA试验也得到了类似结果,抗体反应明显高于初次接种后(p<0.01)。不良反应一般较轻,包括发热(≥37.5摄氏度)、注射部位皮疹和其他部位皮疹。初次接种和加强免疫接种的不良反应发生率无显著差异。共有185名参与者回复了问卷(回复率:68%),初次接种至回复问卷的时间间隔为1.0至7.5年(中位数:4.0年)。初次接种后,未接受加强免疫接种的血清转化者中突破性水痘的患病率为17%,接受加强免疫接种的未血清转化者中为14%,两组之间无显著差异。总之,初次水痘疫苗接种后对PVF儿童进行加强免疫接种不存在安全性问题,并且可以预期会有良好的抗体反应。

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