Pediatrics Department, Brest University Hospital, France.
Vaccine. 2011 May 12;29(21):3753-9. doi: 10.1016/j.vaccine.2011.03.035. Epub 2011 Apr 13.
The aim of the IVANHOE study was to determine the real-world impact of the rotavirus vaccine, controlling for epidemic-to-epidemic variation in disease burden. A population-based prospective cohort study was conducted in Brest City and 7 suburban districts (CUB area), North-western Brittany, France (210,000 inhabitants; 5500 births per year). The vaccination program started in May 2007 for a 2-year period for all infants born in the Brest birth zone through pediatricians, public outpatient clinics and general practitioners. To determine vaccine impact we monitored trends in hospitalizations for rotavirus-specific diarrhea using an active hospital-based surveillance system initiated 5 years before vaccine introduction. The number of hospitalizations for rotavirus-specific diarrhea during the 2008/2009 epidemic in infants less than 2 years of age whose parents lived within the CUB area was modelled as a function of (1) the number of hospitalizations in infants 2-5 years of age to control for epidemic-to-epidemic variation and (2) vaccine introduction. A total of 4684 infants received at least one dose. Of these, 2635 lived within the CUB area. Vaccine coverage for a complete schedule in the CUB area was 47.1%. Poisson modelling revealed a reduction by a factor of 2.04 (1.56-2.66) in the number of hospitalizations during the last epidemic season (2008/2009), the number of observed cases being equal to 30, against an expected number of 61. Relative risk reduction for hospitalizations for rotavirus diarrhea was 98% (95% CI: 83-100%). We observed a noticeable impact of vaccination on rotavirus diarrhea hospitalizations within 2 years of vaccine introduction integrating for the first time rotavirus epidemics variation. The trial is registered with ClinicalTrials.gov, number, NCT00740935.
IVANHOE 研究的目的是确定轮状病毒疫苗的实际影响，同时控制疾病负担的流行变化。这项基于人群的前瞻性队列研究在法国西北部布列塔尼的布雷斯特市和 7 个郊区（CUB 地区）进行（21 万居民；每年有 5500 名婴儿出生）。疫苗接种计划于 2007 年 5 月开始，为期 2 年，为布雷斯特出生区域内所有婴儿通过儿科医生、公共门诊和全科医生提供。为了确定疫苗的影响，我们通过在疫苗引入前 5 年开始的主动医院监测系统，监测轮状病毒特异性腹泻住院的趋势。在年龄小于 2 岁且父母居住在 CUB 地区的婴儿中，2008/2009 年流行期间轮状病毒特异性腹泻的住院人数，作为（1）2-5 岁婴儿住院人数的函数进行建模，以控制流行变化，（2）疫苗接种的引入。共有 4684 名婴儿至少接受了一剂疫苗。其中，2635 名婴儿居住在 CUB 地区。在 CUB 地区，完整接种计划的疫苗覆盖率为 47.1%。泊松模型显示，在上一个流行季节（2008/2009 年），住院人数减少了 2.04 倍（1.56-2.66），观察到的病例数为 30 例，而预期病例数为 61 例。轮状病毒腹泻住院的相对风险降低了 98%（95%CI：83-100%）。我们观察到疫苗接种对轮状病毒腹泻住院的显著影响，这是首次将轮状病毒流行变化纳入其中。该试验在 ClinicalTrials.gov 注册，编号为 NCT00740935。
