The researchers report long-term outcomes from the Qidong Hepatitis B intervention Study (QHBIS), a randomized controlled trial of neonatal HBV vaccination that was conducted between 1983 and 1990 in Qidong County, a rural area in China with a high incidence of HBV-related primary liver cancer (PLC) and other liver diseases. In this study, 41 rural towns (including a total of 77,658 newborns over the study period) were randomized to the intervention (HBV vaccination for all newborns) or control (no vaccination) groups, with two-thirds of the control group participants receiving a catch-up vaccination at age 10-14 years.
By collecting data on new cases of liver diseases over 30 years from a population-based tumor registry, the researchers estimated that the protective efficacy of vaccination was 84% for primary liver cancer (vaccination reduced the incidence of liver cancer by 84%), 70% for death from liver diseases, and 69% for the incidence of infant fulminant hepatitis. Based on survey data collected in 1996-2000 and 2008-2012 on HBsAg seroprevalence, an indicator of current hepatitis B virus (HBV) infection, they conclude that the efficacy of the catch-up vaccination on HBsAg seroprevalence in early adulthood was weak compared to neonatal vaccination (21% versus 72%). While these findings support the importance of neonatal HBV vaccination, the small number of cases of primary liver cancer and other liver diseases observed during the 30-year follow up, the length of follow-up, and the availability of incomplete data on seroprevalence all limit the accuracy of these findings.
The authors say: “Neonatal HBV vaccination significantly decreased HBsAg seroprevalence in childhood through young adulthood and subsequently reduced the risk of PLC and other liver diseases in young adults.” They continue: “Our results also suggest that an adolescence booster should be considered in people who were born to HBsAg-positive mothers and completed HBV neonatal vaccination series.”
Research Article Funding: The current project was support by the State Key Projects Specialized on Infection Diseases (2012ZX10002008), 973 Program Project of China 2013CB910303, and the National Institutes of Health grant HD70324. It was also funded previously by the 6th to 11th key Technologies R&D program of China. The Merck Co. donated the vaccine and conducted the quality control tests. The sponsors of the study had no role in study design, data collection, data analysis, data interpretation, or writing of the manuscript.
Competing Interests: The authors have declared that no competing interests exist.
Citation: Qu C, Chen T, Fan C, Zhan Q, Wang Y, et al. (2014) Efficacy of Neonatal HBV Vaccination on Liver Cancer and Other Liver Diseases over 30-Year Followup of the Qidong Hepatitis B Intervention Study: A Cluster Randomized Controlled Trial. PLoS Med 11(12): e1001774.doi:10.1371/journal.pmed.1001774
Chinese Academy of Medical Sciences & Peking Union Medical College, CHINA
Qidong Liver Cancer Institute, CHINA
National Office for Cancer Prevention and Control, Chinese Academy of Medical Sciences, CHINA
Yale School of Public Health, Yale University School of Medicine, UNITED STATES
State Key Lab of Molecular Oncology, Cancer Institute/Hospital
Chinese Academy of Medical Sciences & Peking Union Medical College
+86 (10) 8778 3103
School of Public Health
Yale School of Medicine
+1 (203) 785 6210
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