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- Title
Association of BCG Vaccination in Childhood With Subsequent Cancer Diagnoses: A 60-Year Follow-up of a Clinical Trial.
- Authors
Usher, Nicholas T.; Chang, Suyoung; Howard, Robin S.; Martinez, Adriana; Harrison, Lee H.; Santosham, Mathuram; Aronson, Naomi E.
- Abstract
Key Points: Question: What is the association of BCG vaccination during childhood with subsequent cancer development? Findings: In this 60-year follow-up of a clinical trial of the BCG vaccine that included 2963 participants vaccinated at a median age of 8 years, those who received the BCG vaccine had a subsequent lung cancer rate of 18.2 cases per 100 000 person-years. Participants who received the placebo had a lung cancer rate of 45.4 cases per 100 000 person-years. Meaning: The findings suggest that receiving BCG vaccination during early childhood is associated with reduced risk of subsequent lung cancer development. This 60-year follow-up of a clinical trial investigates the association between BCG vaccination during childhood and diagnosis with cancer in adulthood. Importance: The BCG vaccine is currently the only approved tuberculosis vaccine and is widely administered worldwide, usually during infancy. Previous studies found increased rates of lymphoma and leukemia in BCG-vaccinated populations. Objective: To determine whether BCG vaccination was associated with cancer rates in a secondary analysis of a BCG vaccine trial. Design, Setting, and Participants: Retrospective review (60-year follow-up) of a clinical trial in which participants were assigned to the vaccine group by systematic stratification by school district, age, and sex, then randomized by alternation. The original study was conducted at 9 sites in 5 US states between December 1935 and December 1998. Participants were 2963 American Indian and Alaska Native schoolchildren younger than 20 years with no evidence of previous tuberculosis infection. Statistical analysis was conducted between August 2018 and July 2019. Interventions: Single intradermal injection of either BCG vaccine or saline placebo. Main Outcomes and Measures: The primary outcome was diagnosis of cancer after BCG vaccination. Data on participant interval health and risk factors, including smoking, tuberculosis infection, isoniazid use, and other basic demographic information, were also collected. Results: A total of 2963 participants, including 1540 in the BCG vaccine group and 1423 in the placebo group, remained after exclusions. Vaccination occurred at a median (interquartile range) age of 8 (5-11) years; 805 participants (52%) in the BCG group and 710 (50%) in the placebo group were female. At the time of follow-up, 97 participants (7%) in the placebo group and 106 participants (7%) in the BCG vaccine group could not be located; total mortality was 633 participants (44%) in the placebo group and 632 participants (41%) in the BCG group. The overall rate of cancer diagnosis was not significantly different in BCG vaccine vs placebo recipients (hazard ratio, 0.82; 95% CI, 0.66-1.02), including for lymphoma and leukemia. The rate of lung cancer was significantly lower in BCG vs placebo recipients (18.2 vs 45.4 cases per 100 000 person-years; hazard ratio, 0.38; 95% CI, 0.20-0.74; P =.005), controlling for sex, region, alcohol overuse, smoking, and tuberculosis. Conclusions and Relevance: Childhood BCG vaccination was associated with a lower risk of lung cancer development in American Indian and Alaska Native populations. This finding has potentially important health implications given the high mortality rate associated with lung cancer and the availability of low-cost BCG vaccines.
- Subjects
UNITED States; BCG immunotherapy; TUBERCULOSIS prevention; ISONIAZID; TUMOR risk factors; ALCOHOLISM; BCG vaccines; CONFIDENCE intervals; INTERVIEWING; LUNG tumors; MEDICAL records; QUESTIONNAIRES; REGRESSION analysis; RESEARCH funding; RISK assessment; SEX distribution; SMOKING; STATISTICAL hypothesis testing; STATISTICS; DATA analysis; SECONDARY analysis; PROPORTIONAL hazards models; DATA analysis software; ACQUISITION of data methodology; MANN Whitney U Test; DISEASE risk factors; ADULTS; CHILDREN; THERAPEUTICS
- Publication
JAMA Network Open, 2019, Vol 2, Issue 9, pe1912014
- ISSN
2574-3805
- Publication type
Article
- DOI
10.1001/jamanetworkopen.2019.12014