Estimating rotavirus vaccine effectiveness in Japan using a screening method

Araki, Kazukuni; Hara, Megumi; Sakanishi, Yuta; Shimanoe, Chisato; Nishida, Yuichiro; Matsuo, Muneaki; Tanaka, Keitaro

doi:10.1080/21645515.2015.1121337

Cited by 18 publications

(8 citation statements)

References 28 publications

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Section: Discussionmentioning

confidence: 99%

“…In Japan, there is a recent study conducted in Saga, a prefecture located in the Southern part of the country, in which the screening method was used to estimate the rotavirus VE [ 13 ]. They reported that the VE (both RV1 and RV5 combined) was 69.5% and 88.8% for clinically-diagnosed rotavirus gastroenteritis and rotavirus hospitalisation, respectively, although the VE was only statistically significant for rotavirus hospitalisation with a broad 95%CI (34.3–100%) [ 13 ]. Unlike Saga prefecture where no rotavirus disease burden study was done prior to vaccine use, it was shown that 13.7 (6.8–20.7)/ 1000 child-years among children less than 5 years of age living in Yuri-Honjo and Nikaho cities during the most recent 10 years before the introduction of rotavirus vaccines in the country [ 7 ].…”

Section: Discussionmentioning

confidence: 99%

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Effectiveness of rotavirus vaccines against hospitalisations in Japan

et al. 2017

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BackgroundIn 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.MethodsThis 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.ResultsOut 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.ConclusionThe 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.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Effectiveness of rotavirus vaccines against hospitalisations in Japan

et al. 2017

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“…Rotarix and RotaTeq were introduced as voluntary vaccination in November 2011 and July 2012, respectively. The effectiveness of the vaccines has been confirmed since two vaccines were introduced with the average vaccine coverage being 47.6% between July 2012 and November 2014 [ 21 – 23 ]. However, the concerns as mentioned above remain to be clarified.…”

Section: Introductionmentioning

confidence: 99%

Identification of vaccine-derived rotavirus strains in children with acute gastroenteritis in Japan, 2012-2015

et al. 2017

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Two live attenuated oral rotavirus vaccines, Rotarix and RotaTeq, have been introduced as voluntary vaccination in Japan since 2011 and 2012, respectively. Effectiveness of the vaccines has been confirmed, whereas concerns such as shedding of the vaccine strains and gastroenteritis cases caused by vaccine strains are not well assessed. We aimed to identify the vaccine strains in children with acute gastroenteritis (AGE) to investigate the prevalence of AGE caused by vaccination or horizontal transmission of vaccine strains. A total of 1,824 stool samples were collected from children with AGE at six outpatient clinics in 2012–2015. Among all, 372 group A rotavirus (RVA) positive samples were screened for vaccine components by real-time RT-PCR which were designed to differentiate vaccine strains from rotavirus wild-type strains with high specificity. For samples possessing both vaccine and wild-type strains, analyses by next-generation sequencing (NGS) were conducted to characterize viruses existed in the intestine. As a result, Rotarix-derived strains were identified in 6 of 372 (1.6%) RVA positive samples whereas no RotaTeq strain was detected. Among six samples, four possessed Rotarix-derived strains while two possessed both Rotarix-derived strains and wild-type strains. In addition, other pathogens such as norovirus, enterovirus and E.coli were detected in four samples. The contribution of these vaccine strains to each patient’s symptoms was unclear as all of the cases were vaccinated 2–14 days before sample collection. Proportion of average coverage for each segmented gene by NGS strongly suggested the concurrent infection of the vaccine-derived strain and the wild-type strain rather than reassortment of these two strains in one sample. This is the first study to report the prevalence of vaccine-derived strains in patients with RVA AGE in Japan as 1.6% without evidence of horizontal transmission. The results emphasized the importance of continuous monitoring on vaccine strains and their clinical impacts on children.

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“…To date, to the best of our knowledge, there are only two studies that evaluated rotavirus vaccine effectiveness in Japan. 18 , 19 One is our own previous case-population study in Saga Prefecture, which reported a 69.5% VE against RVGE and 88.8% VE against severe RVGE requiring hospitalization. 18 That study was important for monitoring VE; it was the first on VE undertaken shortly after introduction of the rotavirus vaccines.…”

Section: Discussionmentioning

confidence: 95%

Case-Control Study of Rotavirus Vaccine Effectiveness Compared to Test-Negative Controls or Hospital Controls

Araki

Hara

Shimanoe

et al. 2019

Journal of Epidemiology

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Background Selection of test-negative controls takes less time and costs less than traditional control selection for evaluating vaccine effectiveness (VE). Here, rotavirus VE was evaluated using hospital controls and compared with test-negative controls to determine whether using the latter can substitute for the former. Methods We recorded gastroenteritis in children from 2 months to 2 years of age at six medical facilities in Saga City between January 4th and May 31st, 2014. Stools from all identified acute gastroenteritis patients were tested for rotavirus using immunochromatography. Rotavirus gastroenteritis (RVGE) cases had test-positive stool, whereas test-negative controls had gastroenteritis but no rotavirus infection; hospital controls were outpatients visiting the same facility for indications other than gastroenteritis. Vaccination status was verified by inspecting maternal and child health records, and demographic data were obtained from a questionnaire completed by the patients’ guardians or from the medical records. Unconditional logistic regression analysis was used to adjust for possible confounding factors. Results Sixty-four RVGE cases, 260 test-negative controls, and 589 hospital controls were enrolled. The characteristics of the two control groups, including RV vaccination history, were similar. The RVGE cases were more likely to have used daycare services than children from either of the two control groups. The VE against RVGE estimated using hospital controls was 86.6% (95% confidence interval [CI], 55.9–96.0%), very similar to the VE using test-negative controls (84.9% [95% CI, 49.6–95.5%]). Conclusions The estimated VE using test-negative controls and hospital controls is similar. Therefore, test-negative controls are considered appropriate for establishing VE.

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Estimating rotavirus vaccine effectiveness in Japan using a screening method

Cited by 18 publications

References 28 publications

Effectiveness of rotavirus vaccines against hospitalisations in Japan

Effectiveness of rotavirus vaccines against hospitalisations in Japan

Identification of vaccine-derived rotavirus strains in children with acute gastroenteritis in Japan, 2012-2015

Case-Control Study of Rotavirus Vaccine Effectiveness Compared to Test-Negative Controls or Hospital Controls

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