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Effectiveness of rotavirus vaccines against hospitalisations in Japan

机译：轮状病毒疫苗对日本住院的有效性

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Background In Japan, rotavirus hospitalisation occurs at a rate from 2.8 to 13.7 per 1000 child-years among children age less than 5?years, and it imposes a substantial burden to the healthcare system in the country. While both monovalent (RV1) and pentavalent (RV5) rotavirus vaccines are licensed in Japan, neither has been incorporated in the national infant immunization programme. In this study, we estimated vaccine effectiveness (VE) in Japan. Methods This study was conducted in Yuri-Kumiai General Hospital located in a city in the north-western part of Japan. Age-eligible children for rotavirus vaccination were enrolled if they were hospitalized for rotavirus gastroenteritis between September 2013 and August 2016. Rotavirus gastroenteritis was defined by the detection of rotavirus antigen by immunochromatography. “Vaccinated” was defined as infant inoculated with at least one dose of either RV1 or RV5. A conditional logistic regression analysis was performed by modelling the year of birth, year of admission, residence of the children and vaccination status, and by matching the age of cases with that of test-negative controls. The adjusted odds ratio of the vaccinated over unvaccinated was then used to calculate VE in the formula of (1 – adjusted odds ratio) × 100. Results Out of the 244 patients enrolled, rotavirus antigen was detected in 55 (22.5%) of whom 10 (18.2%) were vaccinated, whereas 94 (49.7%) of 189 test-negative controls were vaccinated. During the study period, the vaccine uptake rate in the controls increased from 36.2% to 61.8%. On the other hand, the vaccination coverage over the three years was 64.2% in Yuri-Honjo city (three quarters of the catchment), and 91.4% in Nikaho city (one quarter of the catchment). The VE was calculated to be 70.4% (95% confidence interval: 36.0–86.4%, P =?0.002). The point estimate of the VE was lower but its 95% confidence interval overlaps those of the efficacies obtained from clinical trials in Japan. Conclusion The rotavirus vaccine was effective in the real-world setting in Japan as in the clinical trials, and the introduction of rotavirus vaccine in the national infant immunization schedule will substantially reduce the number of rotavirus gastroenteritis hospitalisation in Japan.
机译：背景技术在日本，轮状病毒的住院率在5岁以下的儿童中每1000个儿童年2.8至13.7个儿童年，这给该国的医疗系统带来了沉重负担。虽然日本已批准了单价（RV1）和五价（RV5）轮状病毒疫苗，但两种疫苗均未纳入国家婴儿免疫计划。在这项研究中，我们估算了日本的疫苗有效性（VE）。方法本研究在日本西北部城市尤里·久美爱综合医院进行。如果轮状病毒胃肠炎是在2013年9月至2016年8月之间住院的，则年龄适中的儿童接受轮状病毒疫苗接种。轮状病毒胃肠炎的定义是通过免疫色谱法检测轮状病毒抗原。 “疫苗接种”定义为婴儿接种了至少一剂RV1或RV5。通过对出生年份，入院年份，儿童居住地和疫苗接种状况进行建模，并通过将病例年龄与测试阴性对照的年龄进行匹配，来进行条件逻辑回归分析。然后，将已接种疫苗与未接种疫苗的调整后比值比用于计算公式（1 –调整后比值比）×100。在结果纳入的244例患者中，有55例（22.5％）检出轮状病毒抗原，其中10例（18.2％）接种了疫苗，而189名测试阴性对照中有94例（49.7％）接种了疫苗。在研究期间，对照组的疫苗吸收率从36.2％增加到61.8％。另一方面，尤里-本庄市（流域的四分之三）三年的疫苗接种率是64.2％，尼卡霍市（流域的四分之一）的91.4％。计算得出的VE为70.4％（95％置信区间：36.0-86.4％，P =？0.002）。 VE的点估计值较低，但其95％的置信区间与从日本的临床试验获得的功效重叠。结论轮状病毒疫苗在日本的实际环境中就像在临床试验中一样有效，在国家婴儿免疫计划中引入轮状病毒疫苗将大大减少日本的轮状病毒胃肠炎住院人数。

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