Therapeutic effects of BCG vaccination in adult asthmatic patients: a randomized, controlled trial.
BACKGROUND
Bacille Calmette-Guérin (BCG) vaccination in humans induces Th1 immune responses. Th1 and Th2 cells are reciprocally regulated.


OBJECTIVE
To examine whether BCG vaccination of adult patients with asthma, a Th2-associated allergic disease, is clinically effective.


METHODS
Forty-three moderate-to-severe asthma patients were randomly assigned into groups that received percutaneous injection of 58.2 x 10(7) CFUs BCG (n = 22) or placebo (n = 21) in a double-blinded fashion, on the first day of a 12-week treatment period. Medications were adjusted every 4 weeks to maintain optimal asthma control. Spirometric measurements were performed before treatment and at weeks 4, 8, and 12 after vaccination. The daily peak expiratory flow rate values, asthma symptoms, and medications were also recorded. Tuberculin skin tests, and sputum inflammatory cell and cytokine analyses were carried out before treatment and 12 weeks after vaccination.


RESULTS
BCG vaccination significantly increased forced expiratory volume in 1 second and forced expiratory flow rate 25% to 75% at weeks 4, 8, and 12. Morning peak expiratory flow rate was significantly increased only during the first 4 weeks. Although the asthma symptom scores were not significantly changed, the weekly medication scores were significantly decreased. Tuberculin skin reactivities were significantly increased without significant alterations in induced sputum profiles. In contrast, medication scores and sputum eosinophils were significantly increased, and the interferon-gamma:interleukin-4 ratio in sputum was significantly decreased in the placebo group.


CONCLUSIONS
BCG vaccination improved lung function and reduced medication use in adults with moderate-to-severe asthma. This amelioration was accompanied by a suppressed Th2-type immune response, suggesting that BCG vaccination might be an effective therapeutic modality against asthma.
Choi
Inseon S
IS
Department of Internal Medicine, Chonnam National University Medical School, Chonnam National University Research Institute of Medical Sciences, Kwangju, Korea. ischoi@chonnam.chonnam.ac.kr
Koh
Youngil I
YI
D000328:Adult; D001249:Asthma / Q000503:physiopathology / Q000628:therapy*; D001500:BCG Vaccine / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D006968:Hypersensitivity, Delayed / Q000175:diagnosis; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013147:Spirometry; D013183:Sputum / Q000166:cytology; D018417:Th1 Cells / Q000187:drug effects / Q000276:immunology; D018418:Th2 Cells / Q000187:drug effects / Q000276:immunology; D014374:Tuberculin Test
D001500:BCG Vaccine