基于检测阴性设计评价兰州羔羊株轮状病毒活疫苗对2~35月龄儿童轮状病毒胃肠炎的保护效果

林子安; 杨伟康; 邱双燕; 张钰莹; 陈文盛; 张丽君; 陈宏标; 于传宁

doi:10.16462/j.cnki.zhjbkz.2023.09.008

基于检测阴性设计评价兰州羔羊株轮状病毒活疫苗对2~35月龄儿童轮状病毒胃肠炎的保护效果

doi: 10.16462/j.cnki.zhjbkz.2023.09.008

1.
深圳市龙华区妇幼保健院预防接种门诊，深圳 518109
2.
深圳市龙华区妇幼保健院科教科，深圳 518109
3.
深圳市龙华区疾病预防控制中心流行病与传染病控制科，深圳 518109
4.
深圳市龙华区慢性病防治中心慢性非传染性疾病控制科，深圳 518020

基金项目:

深圳市龙华区科技创新资金项目 2021042

详细信息

通讯作者:
于传宁，E-mail: 10556992@qq.com

陈宏标，E-mail: gesila2021@163.com

中图分类号: R183.4
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出版历程
- 收稿日期: 2022-09-01
- 修回日期: 2022-12-28
- 网络出版日期: 2023-10-12
- 刊出日期: 2023-09-10

Effectiveness of the Lanzhou lamp rotavirus vaccine against rovavirus gastroenteritis among children aged 2-35 months: a test-negative design study

1.
Vaccination Clinic, Shenzhen Longhua Maternity and Child Healthcare Hospital, Shenzhen 518109, China
2.
Science and Education Section, Shenzhen Longhua Maternity and Child Healthcare Hospital, Shenzhen 518109, China
3.
Department of Epidemiology and Infectious Disease Control, Longhua District Center for Disease Control and Prevention, Shenzhen 518109, China
4.
Department of Chronic Non-Communicable Disease Control, Longhua District Chronic Disease Control Center, Shenzhen 518020, China

Funds:

Shenzhen Longhua District Science and Technology Innovation Fund Program 2021042

More Information

Corresponding author: CHEN Hongbiao, E-mail: gesila2021@163.com; YU Chuanning, E-mail: 10556992@qq.com

摘要

摘要: 目的评价兰州羔羊株轮状病毒(rotavirus，RV)(Lanzhou lamp rotavirus，LLR)疫苗对实验室确诊的儿童轮状病毒胃肠炎(rotacirus gastroenteritis，RVGE)的疫苗保护效果(vaccine effectiveness，VE)，为疾病防控政策提供数据支持。方法采用检测阴性设计，通过中国疾病预防控制系统和预防接种信息管理系统收集深圳市龙华区2019―2021年RVGE流行季期间所有实验室确诊腹泻病例和LLR疫苗接种史，使用非条件和条件logistic回归分析模型计算并评价疫苗的校正OR值(adjusted odds ratio，aOR)和VE。结果共1 052例实验室确诊腹泻的患儿纳入研究，其中RV阳性组(RVGE+)849例和阴性对照组(RVGE-)203例，共326例匹配成功(RVGE+组163例，RVGE-组163例)。非条件和条件logistic回归分析模型中，≥1剂次LLR疫苗的VE分别为50.7% (95% CI: 28.2%~66.2%)和50.4%(95% CI: 11.7%~71.8%)。结论 LLR疫苗对2~35月龄儿童在RVGE流行季提供中等程度的保护效果, 并提示LLR疫苗在2~11月龄儿童的接种率过低和第1剂接种年龄过晚。建议对于错过五价重配轮状病毒减毒活(pentavalent human-reassortant rotavirus, RV5)疫苗接种时间窗的儿童应鼓励尽早接种LLR疫苗。
- 轮状病毒疫苗 /
- 轮状病毒胃肠炎 /
- 检测阴性设计 /
- 疫苗保护效果
Abstract: Objective This study aimed to assess the effectiveness of the Lanzhou lamp rotavirus vaccine (LLR) in mitigating laboratory-confirmed rotavirus gastroenteritis (RVGE) in children, with the objective of informing disease prevention and control policy-making. Methods Data pertaining to confirmed paediatric RVGE and the corresponding LLR vaccination history in Longhua District, Shenzhen City, from 2019-2021 during the RVGE epidemic season, were collected from the China Disease Prevention and Control Information System and the Vaccination Information Management System. A test-negative study design was employed. The adjusted odds ratios (aOR) for LLR vaccination rate and vaccine effectiveness (VE) were calculated using unconditional and conditional logistic regression analysis. Results Of the 1052 children with laboratory-confirmed RVGE included in the study, 849 were positive (RVGE+) and 203 were used as a negative control group (RVGE-), with 326 cases successfully matched (163 cases each in the RVGE+ and RVGE- groups). In the analysis model, the VE of ≥1 dose of LLR vaccine were 45.3 (95% CI: 17.8-63.6) and 50.4 (95% CI: 11.7-72.1) in the unconditional and conditional logistic regression models, respectively. Conclusions This suggests that the LLR vaccine offers moderate effectiveness in preventing RVGE in children aged 2-35 months during the epidemic season. However, the study also exposed a low coverage rate of LLR vaccination in children aged 2-11 months, indicating delayed first-dose inoculation. It is recommended that children who have missed the opportunity for pentavalent human-reassortant rotavirus vaccine should receive the LLR vaccine as soon as feasible.
- Rotavirus vaccine /
- Rotavirus gastroenteritis /
- Test-negative design /
- Vaccine effectiveness

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图 1 参与者入组流程

LLR：兰州羔羊株轮状病毒；RV5：五价重配轮状病毒。

Figure 1. Participant enrollment flow chart

LLR: Lanzhou lamp rotavirus; RV5: pentavalent human-reassortant rotavirus.

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表 1 非匹配的RVGE+病例组和RVGE-对照组的基本特征描述

Table 1. Descriptive characteristics of unmatched RVGE+ cases group and RVGE- control group

变量 Variable	病例组[人数(占比/%)] Cases [Number of people (proportion/%)]	对照组[人数(占比/%)] Controls[Number of people(proportion/%)]	χ²值 value	P值 value
性别Gender			0.625	0.429
男Male	497(58.5)	125(61.6)
女Female	352(41.5)	78(38.4)
发病年份Onset year			37.114	< 0.001
2019	472(51.7)	72(35.5)
2020	158(18.6)	36(17.7)
2021	314(29.8)	95(46.8)
发病月份Onset month			140.504	＜0.001
10	81(9.5)	71(35.0)
11	85(10.0)	50(24.6)
12	209(24.6)	36(17.7)
次年1月Next January	265(27.8)	27(13.3)
次年2月Next February	209(24.6)	19(9.4)
月龄Age of months			0.324	0.850
2~ < 12	183(21.6)	44(21.7)
12~ < 24	480(56.5)	111(54.7)
24~ < 36	186(21.9)	48(23.6)
居住区域(街道)Residential area (subdistrict)			6.313	0.097
A街道	146(17.2)	40(19.7)
B街道	192(22.6)	42(20.7)
C街道	280(33.0)	52(25.6)
D街道	231(27.2)	69(34.0)
LLR疫苗接种LLR vaccination			19.025	＜0.001
无Unvaccinated	698(82.2)	139(68.5)
有Vaccinated	151(17.8)	64(31.5)
接种剂次Vaccination			24.213	＜0.001
0	698(82.2)	139(68.5)
1	134(15.8)	52(25.6)
2	17(2.0)	11(5.4)
3	0(0)	1(0.5)
合计Total	849(100.0)	203(100.0)
注：LLR, 兰州羔羊株轮状病毒。 Note: LLR, Lanzhou lamp rotavirus.

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表 2 按照出生日期(±1个月)、就诊日期(±1个月)匹配的RVGE+病例组和RVGE-对照组的基本特征描述

Table 2. Descriptive characteristics of RVGE+ cases group and RVGE-control group by matching age (±1 month)and clinic attending/hospital admission date (±1 month)

变量 Variable	病例组[人数(占比/%)] Cases [Nnumber of people (proportion/%)]	对照组[人数(占比/%)] Controls[Nnumber of people(proportion/%)]	χ²值 value	P值 value
性别Gender			0.456	0.499
男Male	93(57.1)	99(60.7)
女Female	70(42.9)	64(39.3)
发病年份Onset year			0.096	0.953
2019	71(43.6)	71(43.6)
2020	31(19.0)	33(20.2)
2021	61(37.4)	59(36.3)
发病月份Onset month			4.703	0.319
10	35(21.5)	44(27.0)
11	37(22.7)	45(27.6)
12	42(25.8)	28(17.2)
次年1月Next January	29(17.8)	27(16.6)
次年2月Next February	20(12.0)	19(11.7)
月龄Age of months			0.079	0.961
2~ < 12	37(22.7)	35(21.5)
12~ < 24	85(52.1)	87(53.4)
24~ < 36	41(25.2)	41(25.2)
居住区域Residential area			3.009	0.390
A	29(17.8)	27(16.6)
B	35(21.5)	33(20.2)
C	52(31.9)	42(25.8)
D	47(28.8)	61(37.4)
LLR疫苗接种LLR vaccination			3.985	0.046
无Unvaccinated	127(77.9)	111(68.1)
有Vaccinated	36(22.1)	52(31.9)
接种剂次Vaccination			4.998	0.082
0	127(77.9)	111(68.1)
1	32(19.6)	42(25.8)
2	4(2.5)	10(6.1)
3	0(0)	0(0)
合计Total	163(100.0)	163(100.0)
注：LLR, 兰州羔羊株轮状病毒。 Note: LLR, Lanzhou lamp rotavirus.

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表 3 非条件logistic回归分析模型计算LLR疫苗对于2~35月龄儿童RVGE的保护效果

Table 3. LLR vaccine effectiveness against RVGE among children age 2~35 month calculated by unconditional logistic regression analysis

LLR疫苗接种剂次 Number of doses of LLR vaccine	病例组[人数(占比/%)] Cases [Number of people (proportion/%)]	对照组[人数(占比/%)] Controls[Number of people(proportion/%)]	aOR值value (95% CI)	VE%(95% CI)	P值 value
接种月龄Vaccination months old
2~ < 12
1剂dose	9(4.9)	4(9.1)	0.697 (0.186~2.612)	30.7(-161.2~81.4)	0.593
12~ < 24
1剂dose	91(19.0)	37(34.9)	0.422 (0.250~0.711)	57.8(28.1~75.0)	0.001
2剂dose	1(0.3)	5(6.8)	0.019 (0.002~0.174)	81.0(72.6~99.8)	＜0.001
≥1剂dose	92(19.2)	42(37.8)	0.361 (0.218~0.598)	63.9(40.3~78.2)	＜0.001
24~ < 35
1剂dose	34(20.0)	11(26.8)	0.734 (0.312~1.727)	26.6(-72.2~68.8)	0.479
2剂dose	16(10.5)	6(16.7)	0.795 (0.268~2.360)	20.5(-136.0~72.2)	0.680
≥1剂dose	50(26.9)	18(37.5)	0.746 (0.356~1.563)	23.4(-56.3~64.4)	0.438
2~ < 35
≥1剂dose	151(17.8)	64(31.5)	0.493 (0.338~0.718)	50.7(28.2~66.2)	＜0.001
合计Total	849(100.0)	203(100.0)
注：1. LLR, 兰州羔羊株轮状病毒。2. 3剂次LLR的比例过低，LLR所有剂次用≥1剂来表示；非条件logistic回归分析模型调整的部分混杂因素有：就诊年份、就诊月份。 Note: 1. LLR, Lanzhou lamp rotavirus.2. The proportion of LLR in 3 doses is too low, and all doses of LLR are represented by ≥1 dose; Some confounding factors adjusted by unconditioned logistic regression analysis model were: year of visit and month of visit.

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表 4 条件logistic回归模型评价LLR疫苗对于2~35月龄儿童RVGE的保护效果

Table 4. LLR vaccine effectiveness against RVGE among children age 2-35 month by conditional logistic regression model

LLR疫苗接种剂次 Number of doses of LLR vaccine	病例组[人数(占比/%)] Cases [Number of people (proportion/%)]	对照组[人数(占比/%)] Controls[Number of people(proportion/%)]	cOR值value (95% CI)^①	VE%(95% CI)	P值 value
接种月龄Vaccination months old
2~ < 12
1剂dose	4(10.8)	4(11.4)	0.958 (0.157~5.854)	4.2(-485.4~84.3)	0.958
12~ < 24
1剂dose	16(18.8)	30(34.5)	0.304(0.131~0.709)	69.6(19.1~86.9)	0.003
2剂dose	0(0)	5(5.7)
≥1剂dose	16(18.8)	35(40.2)	0.259(0.113~0.595)	74.1(40.5~88.7)	0.001
24~ < 35
1剂dose	13(31.0)	8(19.5)	1.333(0.463~3.843)	-33.3(-284.3~53.7)	0.594
2剂dose	4(9.5)	5(12.2)	2.000(0.181~22.056)	-100.0(-2105.6~81.9)	0.571
≥1剂dose	16(39.0)	13(31.7)	1.429(0.544~3.753)	-42.9(-265.3~45.6)	0.469
2~ < 35
≥1剂dose	36(22.1)	52(31.9)	0.499(0.282~0.883)	50.1(11.7~71.8)	0.017
合计Total	163(100.0)	163(100.0)
注：LLR, 兰州羔羊株轮状病毒。①匹配后的条件logistic回归分析模型计算OR时，OR无需校正。Note: LLR, Lanzhou lamp rotavirus.① When the matched conditional logistic regression analysis model calculates OR, OR does not need to be corrected.

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基于检测阴性设计评价兰州羔羊株轮状病毒活疫苗对2~35月龄儿童轮状病毒胃肠炎的保护效果

doi: 10.16462/j.cnki.zhjbkz.2023.09.008

通讯作者:
于传宁，E-mail: 10556992@qq.com

陈宏标，E-mail: gesila2021@163.com

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Effectiveness of the Lanzhou lamp rotavirus vaccine against rovavirus gastroenteritis among children aged 2-35 months: a test-negative design study

Corresponding author: CHEN Hongbiao, E-mail: gesila2021@163.com; YU Chuanning, E-mail: 10556992@qq.com

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基于检测阴性设计评价兰州羔羊株轮状病毒活疫苗对2~35月龄儿童轮状病毒胃肠炎的保护效果

doi: 10.16462/j.cnki.zhjbkz.2023.09.008

通讯作者: 于传宁，E-mail: 10556992@qq.com 陈宏标，E-mail: gesila2021@163.com

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Effectiveness of the Lanzhou lamp rotavirus vaccine against rovavirus gastroenteritis among children aged 2-35 months: a test-negative design study

Corresponding author: CHEN Hongbiao, E-mail: gesila2021@163.com; YU Chuanning, E-mail: 10556992@qq.com

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通讯作者:
于传宁，E-mail: 10556992@qq.com

陈宏标，E-mail: gesila2021@163.com