What type of study is this?

This is a Human Clinical Trial study.

What question did this study set out to answer?

Assess the effectiveness of the BCG vaccine in preventing primary tuberculosis among newborns and school children.

January 14, 2026Open Forum Infectious Diseases0 citationsOpen Access

P-1398. BCG Vaccine Prevents Primary Tuberculosis in Newborns and School Children

NANaomi AronsonUniformed Services University of the Health Sciences AHAndrew HillUniformed Services University of the Health Sciences COCara H. OlsenUniformed Services University of the Health Sciences

Key Points

Assess the effectiveness of the BCG vaccine in preventing primary tuberculosis among newborns and school children.
Data from a controlled trial of BCG in AI/AN schoolchildren and a case control trial of newborns were reviewed.
Annual intradermal PPD testing and chest radiographs were performed to monitor tuberculosis development.
Cox proportional hazards regression model was used for outcome analysis of primary pulmonary TB and severe TB.
Primary pulmonary TB occurred in 122 BCG recipients and 302 placebo recipients, with an HR of 0.34.
For newborns, the adjusted HR for any TB was 0.36, indicating better outcomes for those receiving BCG.
BCG vaccine resulted in a significant reduction in severe TB cases among schoolchildren and newborns.

Abstract

Abstract Background Tuberculosis (TB) leads global infectious diseases that cause mortality. Widely used BCG vaccine protects against TB disease (especially miliary, meningeal forms) but the protection of primary TB is inconclusive. Our objective was to assess the effectiveness of BCG vaccine to prevent primary TB using prospectively collected data in a clinical trial. Methods This study was approved by the USUHS Institutional Review Board. Data from a controlled trial of BCG (Phipps) in American Indian/Alaskan Native (AI/AN) schoolchildren, n=2763, enrolled 1935-8, and a case control trial of 257 newborns in Rosebud SD, Belcourt ND enrolled 1939-40, were reviewed. Before (schoolchildren only) and after BCG vaccination annual intradermal PPD testing and chest radiographs (CXR) were performed through 1947. Inclusion criteria for this analysis were negative PPD and normal CXR prior to vaccination (schoolchildren), received placebo or BCG vaccine, had a follow-up assessment. Exclusion included reactive or undocumented PPD or abnormal CXR prior to immunization. Primary pulmonary TB was defined as hilar adenopathy, lower lobe infiltrates without other identified etiology, +/- pleural effusion. In the control arm, conversion of PPD 10mm was considered in the context of radiographic findings. Severe TB was miliary or meningeal. Cox proportional hazards regression model with hazard ratios (HR) and 95% confidence intervals (95%CI) was performed for outcomes of primary pulmonary TB and severe TB. Results 2731 AI/AN schoolchildren, mean age 7.6 years, were evaluated. 1416 received BCG, 1315 placebo. Primary pulmonary TB occurred in 122 BCG, 302 placebo recipients with a sex, age, region-adjusted Cox proportional HR of 0.34, 95% CI 0.28,0.42 for BCG vaccine. 253 newborns were analyzed; 116 received BCG, 137 placebo. For newborns a sex and region adjusted HR for any TB was reported.CohortPrimary TB adjusted HR (BCG)Severe TB adjusted HR (BCG)Schoolchildren n=27310.34 (95CI 0.28,0.42)0.24 (95CI 0.08, 0.74)Newborn n=2530.36 (95CI 0.13, 0.996)0 cases BCG, 2 cases placebo Conclusion In this heavily TB-exposed AI/AN population, BCG was quite effective in preventing primary pulmonary TB in newborns (64%) or schoolchildren (66%), as well as meningeal or miliary TB (76%). Disclosures Naomi E. Aronson, MD, Wolters Kluwer: royalties for writing for uptodate Lee Harrison, MD, GSK: Advisor/Consultant|Merck: Board Member|Pfizer: Advisor/Consultant|Sanofi: Advisor/Consultant

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