Summary of Evidence
Note: Separate PDQ summaries on Liver (Hepatocellular) Cancer Screening; Adult Primary Liver Cancer Treatment; Childhood Liver Cancer Treatment; and Levels of Evidence for Cancer Screening and Prevention Studies are also available.Hepatitis B Vaccine to Prevent Hepatocellular Cancer
Based on solid evidence, immunizing individuals against hepatitis B would lead to a decrease in the incidence of hepatocellular cancer (HCC).
Description of the Evidence
- Study Design: Evidence obtained from cohort or case-control studies.
- Internal Validity: Fair (ecologic control; no direct comparison group).
- Consistency: Limited number of studies.
- Magnitude of Effects on Health Outcomes: Reduction of risk occurs with prevention of hepatitis B infection in one intervention study. A study in Taiwan shows that vaccination of newborns (the vaccination program includes administration of hepatitis B immunoglobulin at birth, followed by a course of hepatitis B vaccine) of mothers infected with hepatitis B virus was associated with a reduction in the average annual incidence of HCC from 0.70 per 100,000 children between 1981 and 1986 to 0.57 and 0.36 for the time periods of 1986 to 1990 and 1990 to 1994, respectively (P < .01). Although there was no direct control group, the decline in incidence of HCC over time would unlikely be explained by other causes. Failures in a vaccination program may be related to either failure to receive hepatitis B immunoglobulin or failure of the hepatitis B vaccine itself.
- External Validity: Good.
- Chang MH, Chen CJ, Lai MS, et al.: Universal hepatitis B vaccination in Taiwan and the incidence of hepatocellular carcinoma in children. Taiwan Childhood Hepatoma Study Group. N Engl J Med 336 (26): 1855-9, 1997. [PUBMED Abstract]
- Chang MH, Chen TH, Hsu HM, et al.: Prevention of hepatocellular carcinoma by universal vaccination against hepatitis B virus: the effect and problems. Clin Cancer Res 11 (21): 7953-7, 2005. [PUBMED Abstract]