Observational studyLiver cancer

Universal Hepatitis B Vaccination in Taiwan and the Incidence of Hepatocellular Carcinoma in Children

N Engl J Med · 1997Details in the full text
Chang MH, Chen CJ, Lai MS, Hsu HM, Wu TC, Kong MS, et al. N Engl J Med. 1997. 336:1855-1859
Study type
Observational study
Study name
Taiwan Childhood Hepatoma Study
Design
Population-based cancer registry study (analysis of incidence trends over time, 1981 to 1994)
Sample size
Details in the full text
Source
N Engl J Med · 1997

In plain words

In Taiwan, all newborn babies have been vaccinated against hepatitis B since 1984. After that, the number of children who developed liver cancer (hepatocellular carcinoma) fell noticeably. This finding shows that the hepatitis B vaccine can help prevent liver cancer.

Key results

0.70 (1981 to 1986), 0.57 (1986 to 1990), 0.36 (1990 to 1994)
Mean annual incidence of hepatocellular carcinoma in children aged 6 to 14 years (per 100,000 children)
P<0.01
0.52 (born 1974 to 1984) vs 0.13 (born 1984 to 1986)
Incidence in children aged 6 to 9 years by birth year
P<0.001
Decreased
Mortality from hepatocellular carcinoma
Exact figure not given in the abstract

Treatment arms and regimens

1Time periods before and after the start of the vaccination programme

Taiwan's national hepatitis B vaccination programme began in July 1984. Cancer incidence was compared across the periods 1981 to 1986, 1986 to 1990 and 1990 to 1994. Vaccine and dose details in the full text.

Source of the regimen details: Abstract of the paper

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Taiwanese children with liver cancer recorded in the Taiwan national cancer registry (reports from 142 hospitals with more than 50 beds) and at 17 major medical centres in Taiwan. To avoid including hepatoblastoma cases, the main analysis was limited to liver cancers in children aged 6 years and older.

Endpoints

Primary endpoint: annual incidence of hepatocellular carcinoma in children. Liver cancer mortality in children was also examined.

Safety and side effects

This study examined cancer incidence, and vaccine adverse events are not reported in the abstract.

Clinical significance and place in guidelines

This study is among the first population-level evidence that a universal hepatitis B vaccination programme is associated with a lower incidence of liver cancer in children, establishing the vaccine as a means of cancer prevention. The abstract gives no information on changes to guidelines or approvals, and the status of current recommendations should be checked separately.

Limitations

This study is observational, based on comparison of time periods, with no randomised control group; so, according to the abstract, a causal relationship is not certain. Other limitations are not stated in the abstract and should be checked in the full text.

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.