Effectiveness of the live attenuated rotavirus vaccine produced by a domestic manufacturer in China studied using a population-based case–control design

Shan-Shan Zhen,Yue Li,Song-Mei Wang,Xin-Jiang Zhang,Zhi-Yong Hao,Ying Chen,Dan Wang,Yan-Hong Zhang,Zhi-Yong Zhang,Jing-Chen Ma,Peng Zhou,Zhen Zhang,Zhi-Wei Jiang,Yu-Liang Zhao,Xuan-Yi Wang

doi:10.1038/emi.2015.64

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.

Highlights

Acute gastroenteritis is the leading cause of childhood illness worldwide and in China.[1,2] Rotavirus (RV) is the leading pathogen that causes severe gastroenteritis in children,[3,4,5] and infects virtually all children by 5 years of age in both industrialized and developing countries.[4,6] Improving the safety control of water and food and implementing a better sanitation program seem unlikely to reduce the occurrence of diseases caused by RV.[7]
The aim of this study was to define the occurrences of RV, calicivirus, astrovirus, and adenovirus infection in this study population, and this study provided a good opportunity for evaluating the effectiveness of Lanzhou lamb rotavirus vaccine (LLR) using a population-based case–control design
The population-based diarrhea surveillance provided a unique opportunity to test the effectiveness of the LLR in a real-world setting

Summary

Introduction

Acute gastroenteritis is the leading cause of childhood illness worldwide and in China.[1,2] Rotavirus (RV) is the leading pathogen that causes severe gastroenteritis in children,[3,4,5] and infects virtually all children by 5 years of age in both industrialized and developing countries.[4,6] Improving the safety control of water and food and implementing a better sanitation program seem unlikely to reduce the occurrence of diseases caused by RV.[7] In China, published data indicates that. A cost-effectiveness analysis indicated that a universal RV immunization program can be expected to result in high net savings by decreasing the hospitalizations of immunized patients.[6] As China is the country with the largest human population in the world, it should consider RV vaccination as a potential cost-effective measure against RV infection.[4]

Objectives

Methods

Results

Conclusion