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2016 - 2021年在越南两个省份常规使用条件下Rotavin - M1的影响与效果:一项观察性和病例对照研究

Impact and effectiveness of Rotavin-M1 under conditions of routine use in two provinces in Vietnam, 2016-2021, an observational and case-control study.

作者信息

Van Trang Nguyen, Tate Jacqueline E, Phuong Mai Le Thi, Vu Thiem Dinh, Quyet Nguyen Tu, Thi Le Ly Khanh, Thi Chu Mai Ngoc, Ngoc Tran Mai Phuong, Thi Pham Thao Phuong, Nguyen Huong Thuy, Hien Nguyen Dang, Jiang Baoming, Yen Catherine, Tran Duong Nhu, Anh Dang Duc, Parashar Umesh D

机构信息

National Institute of Hygiene and Epidemiology, Hanoi, Viet Nam.

United States Centers for Disease Control and Prevention, Atlanta, GA, USA.

出版信息

Lancet Reg Health West Pac. 2023 May 18;37:100789. doi: 10.1016/j.lanwpc.2023.100789. eCollection 2023 Aug.

DOI:10.1016/j.lanwpc.2023.100789
PMID:37693867
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10485664/
Abstract

BACKGROUND

Half of diarrhea hospitalizations in children aged <5 years in Vietnam are due to rotavirus. Following introduction of a locally developed and licensed oral rotavirus vaccine, Rotavin-M1, into the routine immunization program in two Vietnamese provinces, Nam Dinh and TT Hue, we describe changes in rotavirus positivity among children hospitalized for diarrhea and calculate vaccine effectiveness against moderate-to-severe rotavirus hospitalizations.

METHODS

Active rotavirus surveillance among children <5 years began in December 2016 at sentinel hospitals in districts where rotavirus vaccine was introduced in December 2017. To estimate reductions in rotavirus detection, we calculated risk ratios comparing rotavirus positivity pre- and post-vaccine introduction. We used a test-negative case-control design to calculate vaccine effectiveness.

FINDINGS

From December 2016 to May 2021, 7228 children <5 years hospitalized for diarrhea were enrolled. Following introduction, Rotavin-M1 coverage was 77% (1066/1377) in Nam Dinh and 42% (203/489) in TT Hue. In Nam Dinh, rotavirus positivity among children <5 years significantly declined by 40.6% (95% CI: 34.8%-45.8%) during the three-year post-vaccine introduction period. In TT Hue, no change in rotavirus positivity was observed. Among children aged 6-23 months, a 2-dose series of Rotavin-M1 was 57% (95% CI: 39%-70%) effective against moderate-to-severe rotavirus hospitalizations.

INTERPRETATION

Higher vaccination coverage in Nam Dinh than TT Hue likely contributed to substantial declines in rotavirus positivity observed in Nam Dinh following rotavirus vaccine introduction. Robust vaccine effectiveness was observed through the second year of life. National rotavirus vaccine introduction with high coverage may have substantial impact on reducing rotavirus disease burden in Vietnam.

FUNDING

Bill and Melinda Gates Foundation.

摘要

背景

在越南,5岁以下儿童因腹泻住院的病例中有一半是由轮状病毒引起的。在将本地研发并获许可的口服轮状病毒疫苗Rotavin-M1引入越南南定省和承天顺化省的常规免疫规划后,我们描述了腹泻住院儿童中轮状病毒阳性率的变化,并计算了该疫苗针对中重度轮状病毒住院病例的有效性。

方法

2016年12月开始在2017年12月引入轮状病毒疫苗的地区的哨点医院对5岁以下儿童开展轮状病毒主动监测。为评估轮状病毒检测率的降低情况,我们计算了疫苗引入前后轮状病毒阳性率的风险比。我们采用检测阴性病例对照设计来计算疫苗有效性。

研究结果

2016年12月至2021年5月,共有7228名5岁以下因腹泻住院的儿童入组。疫苗引入后,南定省的Rotavin-M1覆盖率为77%(1066/1377),承天顺化省为42%(203/489)。在南定省,疫苗引入后的三年期间,5岁以下儿童的轮状病毒阳性率显著下降了40.6%(95%CI:34.8%-45.8%)。在承天顺化省,未观察到轮状病毒阳性率有变化。在6至23个月大的儿童中,两剂次的Rotavin-M1针对中重度轮状病毒住院病例的有效性为57%(95%CI:39%-70%)。

解读

南定省的疫苗接种覆盖率高于承天顺化省,这可能是南定省在引入轮状病毒疫苗后轮状病毒阳性率大幅下降的原因。在生命的第二年观察到了强劲的疫苗有效性。在越南全国范围内高覆盖率引入轮状病毒疫苗可能对减轻轮状病毒疾病负担产生重大影响。

资金来源

比尔及梅琳达·盖茨基金会

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd5/10485664/f5e1d40c8187/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd5/10485664/7c5782e43aec/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd5/10485664/575fbcbafe3d/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd5/10485664/e997971a47a7/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd5/10485664/f5e1d40c8187/gr4.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd5/10485664/7c5782e43aec/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd5/10485664/575fbcbafe3d/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd5/10485664/e997971a47a7/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fdd5/10485664/f5e1d40c8187/gr4.jpg

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