title: Effectiveness of the live attenuated rotavirus vaccine produced by a domestic manufacturer in China studied using a population-based case-control design.
abstract: A universal rotavirus (RV) immunization program is a potentially cost-effective measure for preventing RV infection in China. However, the efficacy of the only licensed RV vaccine (Lanzhou lamb rotavirus vaccine, LLR), which is made by a domestic manufacturer, has not been proven by a properly designed clinical trial. In October 2011 to March 2012, to measure the potential protection provided by LLR, a case-control study nested in a population-based active diarrhea surveillance study of children <5 years of age was conducted in rural Zhengding county. During the study period, 308 episodes of diarrhea were identified as being caused by RV infection, resulting in an incidence rate of 48.0/1000 people/year. The predominant RV serotype was G3 (61.5%), followed by G1 (15.2%), and G9 (6.5%). Overall, a protection of 35.0% (95% confidence interval (CI), 13.0%-52.0%) was identified, and higher protection was found among moderate RV gastroenteritis cases caused by the serotype G3 (52.0% 95% CI: 2.0%-76.1%). A concurrently conducted case-control study comparing non-RV viral diarrheal cases with non-diarrheal controls in the same population found that the RV vaccine offered no protection against non-RV diarrhea. Even under a less ideal immunization schedule, the oral LLR conferred a certain level of protection against RV gastroenteritis. However, further studies are needed to understand the full characteristics of the LLR, including its efficacy when administered following the optimal regimen, the potential risk of inducing intussusception, and the direct and indirect protective effects of LLR.
authors.affiliation: Key Laboratory Medical Molecular Virology, MoE/MoH, and the Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University , Shanghai 200032, China.
authors.forename: Shan-Shan
authors.initials: SS
authors.lastname: Zhen
authors.affiliation: Key Laboratory Medical Molecular Virology, MoE/MoH, and the Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University , Shanghai 200032, China.
authors.forename: Yue
authors.initials: Y
authors.lastname: Li
authors.affiliation: Laboratory of Molecular Biology, Training Center of Medical Experiments, School of Basic Medical Sciences, Fudan University , Shanghai 200032, China.
authors.forename: Song-Mei
authors.initials: SM
authors.lastname: Wang
authors.affiliation: Zhengding County Center for Disease Control and Prevention , Zhengding 050800, Hebei Province, China.
authors.forename: Xin-Jiang
authors.initials: XJ
authors.lastname: Zhang
authors.affiliation: Zhengding County Center for Disease Control and Prevention , Zhengding 050800, Hebei Province, China.
authors.forename: Zhi-Yong
authors.initials: ZY
authors.lastname: Hao
authors.affiliation: Key Laboratory Medical Molecular Virology, MoE/MoH, and the Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University , Shanghai 200032, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Key Laboratory Medical Molecular Virology, MoE/MoH, and the Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University , Shanghai 200032, China.
authors.forename: Dan
authors.initials: D
authors.lastname: Wang
authors.affiliation: Zhengding County Center for Disease Control and Prevention , Zhengding 050800, Hebei Province, China.
authors.forename: Yan-Hong
authors.initials: YH
authors.lastname: Zhang
authors.affiliation: Zhengding County Center for Disease Control and Prevention , Zhengding 050800, Hebei Province, China.
authors.forename: Zhi-Yong
authors.initials: ZY
authors.lastname: Zhang
authors.affiliation: Hebei Province Center for Disease Control and Prevention , Shijiazhuang 050800, Hebei Province, China.
authors.forename: Jing-Chen
authors.initials: JC
authors.lastname: Ma
authors.affiliation: Key Laboratory Medical Molecular Virology, MoE/MoH, and the Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University , Shanghai 200032, China.
authors.forename: Peng
authors.initials: P
authors.lastname: Zhou
authors.affiliation: Key Laboratory Medical Molecular Virology, MoE/MoH, and the Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University , Shanghai 200032, China.
authors.forename: Zhen
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Department of Health Statistics, Fourth Military Medical University , Xi'an 710032, Shanxi Province, China.
authors.forename: Zhi-Wei
authors.initials: ZW
authors.lastname: Jiang
authors.affiliation: Hebei Province Center for Disease Control and Prevention , Shijiazhuang 050800, Hebei Province, China.
authors.forename: Yu-Liang
authors.initials: YL
authors.lastname: Zhao
authors.affiliation: Key Laboratory Medical Molecular Virology, MoE/MoH, and the Institutes of Biomedical Sciences, Shanghai Medical College, Fudan University , Shanghai 200032, China.
authors.forename: Xuan-Yi
authors.initials: XY
authors.lastname: Wang
mesh_terms: D000284:Administration, Oral; D000818:Animals; D016022:Case-Control Studies; D002675:Child, Preschool; D002681:China; D015331:Cohort Studies; D003967:Diarrhea / Q000517:prevention & control* / Q000821:virology; D005243:Feces / Q000821:virology; D005759:Gastroenteritis / Q000517:prevention & control* / Q000821:virology; D060005:Genotyping Techniques; D006801:Humans; D007223:Infant; D016017:Odds Ratio; D011159:Population Surveillance; D012401:Rotavirus / Q000145:classification / Q000235:genetics / Q000302:isolation & purification; D012400:Rotavirus Infections / Q000517:prevention & control* / Q000821:virology; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000592:standards*; D012720:Severity of Illness Index; D012756:Sheep; D011795:Surveys and Questionnaires; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000592:standards
chemical_list: D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: China; attenuated vaccine; case–control study; effectiveness; rotavirus