Bacille Calmette-Guerin (BCG) is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis. The TICE® strain used in this BCG vaccine preparation was developed at the University of Illinois from a strain originated at the Pasteur Institute.
BCG is used in many countries with a high prevalence of TB to prevent childhood tuberculous, meningitis and miliary disease. However, BCG is not generally recommended for use in the United States because of the low risk of infection with Mycobacterium tuberculosis, the variable effectiveness of the vaccine against adult pulmonary TB, and the vaccine’s potential interference with tuberculin skin test reactivity.
The BCG vaccine should be considered only for very select persons who meet specific criteria and in consultation with a TB expert.
BCG is administered by the percutaneous route with a multiple puncture device. BCG should not be administered INTRAVENOUSLY, SUBCUTANEOUSLY, INTRAMUSCULARLY OR INTRADERMALLY.
September 25, 2019: This retrospective review was a 60-year follow-up of a clinical trial of the BCG vaccine that included 2963 participants vaccinated at a median age of 8 years.
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.
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.
However, those who received the BCG vaccine had a subsequent lung cancer rate of 18.2 cases per 100 000 person-years.
Compared to participants who received the placebo had a lung cancer rate of 45.4 cases per 100 000 person-years.
BCG is currently involved in 102 active, recruiting clinical trials covering various cancers and other conditions.
Click here to review the various ongoing clinical trials.