Long-term efficacy of BCG vaccine in American Indians and Alaska Natives: A 60-year follow-up study.
JAMA
; 291(17): 2086-91, 2004 May 05.
Article
in En
| MEDLINE
| ID: mdl-15126436
ABSTRACT
CONTEXT The duration of protection from tuberculosis of BCG vaccines is not known. OBJECTIVE:
To determine the long-term duration of protection of a BCG vaccine that was previously found to be efficacious.DESIGN:
Retrospective record review using Indian Health Service records, tuberculosis registries, death certificates, and supplemental interviews with trial participants. SETTING ANDPARTICIPANTS:
Follow-up for the period 1948-1998 among American Indians and Alaska Natives who participated in a placebo-controlled BCG vaccine trial during 1935-1938 and who were still at risk of developing tuberculosis. Data from 1483 participants in the BCG vaccine group and 1309 in the placebo group were analyzed. MAIN OUTCOMEMEASURES:
Efficacy of BCG vaccine, calculated for each 10-year interval using a Cox regression model with time-dependent variables based on tuberculosis events occurring after December 31, 1947 (end of prospective case finding).RESULTS:
The overall incidence of tuberculosis was 66 and 138 cases per 100 000 person-years in the BCG vaccine and placebo groups, respectively, for an estimate of vaccine efficacy of 52% (95% confidence interval, 27%-69%). Adjustments for age at vaccination, tribe, subsequent BCG vaccination, chronic medical illness, isoniazid use, and bacille Calmette-Guérin strain did not substantially affect vaccine efficacy. There was slight but not statistically significant waning of the efficacy of BCG vaccination over time, greater among men than women.CONCLUSION:
In this trial, BCG vaccine efficacy persisted for 50 to 60 years, suggesting that a single dose of an effective BCG vaccine can have a long duration of protection.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Tuberculosis
/
BCG Vaccine
/
Indians, North American
Type of study:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limits:
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
JAMA
Year:
2004
Document type:
Article
Affiliation country:
Estados Unidos