Gong Xiaohuan, Huang Zhuoying, Zheng Yaxu, Xiao Wenjia, Liu Jiechen, Lin Sheng, Pan Hao, Chen Jian, Wu Huanyu, Wang Weibing
Department of Epidemiology, School of Public Health, Fudan University, Shanghai, China; Division of Infectious Disease Control and Prevention, Shanghai Municipal Center of Disease Control and Prevention, Shanghai, China.
Department of Epidemiology, School of Public Health, Fudan University, Shanghai, China; Division of Immunization Program, Shanghai Municipal Center for Disease Control and Prevention, Shanghai, China.
Vaccine. 2025 Feb 27;48:126731. doi: 10.1016/j.vaccine.2025.126731. Epub 2025 Jan 13.
The number of post-marketing studies assessing the vaccine effectiveness (VE) of the Lanzhou lamb rotavirus vaccine (LLR, licensed in 2000 exclusively in China) and the oral human attenuated pentavalent rotavirus vaccine (RotaTeq, licensed in China in 2018) in China is limited.
A test-negative case-control study based on prospective surveillance was conducted among diarrhea patients aged 5 years and younger at five hospitals in Shanghai, China. Cases and controls were defined based on the results of real-time fluorescent quantitative reverse transcription polymerase chain reaction (rRT-PCR) of fecal samples for rotavirus. Both matched and unmatched case-control study designs were employed using logistic regression models, with adjustments for age at onset age and the rotavirus epidemic season.
In the LLR-specific analysis (247 cases, 2191 controls), the VE of partial LLR vaccination (2 doses) was 49.09 % (95 % CI: 1.69 % ∼ 73.64 %) in multivariate analyses. In the RotaTeq-specific analysis (42 cases and 523 controls), the VE of complete RotaTeq vaccination was 87.13 % (95 % CI: 45.87 % ∼ 96.94 %), 89.46 % (95 % CI: 55.03 % ∼ 97.53 %), and 85.69 % (95 % CI: 33.43 % ∼ 96.93 %) respectively in univariate, multivariate, and matched analyses, respectively. The vaccination coverage for any dose among 2893 patients with rotavirus-negative diarrhea born between 2011 and 2022 was 49.78 %. Following the licensure of RotaTeq in 2018, this coverage increased from 45.02 % to 61.77 %.
RotaTeq demonstrates a robust protective effectiveness, while LLR provides a certain level of protection against mild to moderate rotavirus diarrhea in children in Shanghai. For privately purchased (non-NIP) vaccines, we estimate that the coverage for rotavirus vaccines among children in Shanghai is high. Complete rotavirus vaccination is recommended for age-eligible children. Further post-marketing research on rotavirus vaccines is necessary to inform decision-making regarding the introduction of rotavirus vaccination in China.
评估兰州羊轮状病毒疫苗（LLR，2000年在中国独家获批上市）和口服人用五价重配轮状病毒减毒活疫苗（RotaTeq，2018年在中国获批上市）疫苗效力（VE）的上市后研究数量有限。
在中国上海的五家医院对5岁及以下腹泻患者开展了一项基于前瞻性监测的检测阴性病例对照研究。根据粪便样本轮状病毒实时荧光定量逆转录聚合酶链反应（rRT-PCR）结果定义病例和对照。采用匹配和非匹配病例对照研究设计，使用逻辑回归模型，并对发病年龄和轮状病毒流行季节进行调整。
在LLR特异性分析（247例病例，2191例对照）中，多因素分析显示部分接种LLR（2剂）的疫苗效力为49.09%（95%CI：1.69%～73.64%）。在RotaTeq特异性分析（42例病例和523例对照）中，单因素分析、多因素分析和匹配分析中，全程接种RotaTeq的疫苗效力分别为87.13%（95%CI：45.87%～96.94%）、89.46%（95%CI：55.03%～97.53%）和85.69%（95%CI：33.43%～96.93%）。2011年至2022年出生的2893例轮状病毒阴性腹泻患者中，任何剂量的疫苗接种覆盖率为49.78%。2018年RotaTeq获批上市后，这一覆盖率从45.02%增至61.77%。
RotaTeq显示出强大的保护效力，而LLR为上海儿童的轻至中度轮状病毒腹泻提供了一定程度的保护。对于私人购买（非国家免疫规划）疫苗，我们估计上海儿童轮状病毒疫苗的接种覆盖率较高。建议符合年龄条件的儿童全程接种轮状病毒疫苗。有必要对轮状病毒疫苗开展进一步的上市后研究，为中国引入轮状病毒疫苗的决策提供依据。
