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JAMA. 2004 May 5;291(17):2086-91.

Long-term efficacy of BCG vaccine in American Indians and Alaska Natives: A 60-year follow-up study.

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  • 1Department of Medicine, Infectious Disease Division, Uniformed Services University of the Health Sciences, Bethesda, Md 20814, USA. naronson@usuhs.mil

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 AND PARTICIPANTS:

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 OUTCOME MEASURES:

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.

PMID:
15126436
DOI:
10.1001/jama.291.17.2086
[PubMed - indexed for MEDLINE]
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