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Peer reviewedOpen accessTuberculosis

Protection by BCG Vaccine Against Tuberculosis: A Systematic Review of Randomized Controlled Trials

Clinical Infectious Diseases·

Punam Mangtani, Ibrahim Abubakar, Cono Ariti, Rebecca Beynon, Laura Pimpin, Paul E. M. Fine, Laura C. Rodrigues, Peter G. Smith, Marc Lipman, Penny F. Whiting, Jonathan A. Sterne

DOI
10.1093/cid/cit790
PMID
24336911
PMCID
OpenAlex
W2010318115
Study type
Systematic review
Publisher
Oxford University Press (OUP)
Article type
journal-article
Integrity
current

Why this research matters now

Recognizing how baseline exposure status and methodological choices affect outcome measurements may guide the planning and evaluation of future immunization initiatives.

01

Structured evidence summary

Research question

How do trial design features and participant characteristics influence the measured effectiveness of the BCG immunization against tuberculosis?

Study design

The authors performed a systematic review and meta-analysis of randomized controlled trials, incorporating meta-regression techniques to assess how specific trial attributes modify reported outcomes.

Population and setting

Data were aggregated from eighteen studies evaluating pulmonary disease and six examining severe disseminated or central nervous system forms, covering diverse geographic locations and age cohorts.

Main findings

Reported protection levels fluctuated significantly depending on screening rigor, participant age, and geographic latitude. Highest efficacy estimates occurred in infants and subjects who received thorough testing to exclude previous bacterial exposure. Measured benefits also increased in regions farther from the equator and under stricter diagnostic conditions, whereas vaccine strain variations showed no consistent relationship with outcomes.

Public-health relevance

Recognizing how baseline exposure status and methodological choices affect outcome measurements may guide the planning and evaluation of future immunization initiatives.

Important limitations

Statistical associations between trial characteristics and efficacy diminished when evaluated simultaneously within multivariable frameworks, indicating potential overlapping influences among study variables.

GIDS interpretation

This synthesis consolidates historical trial data to establish a reference framework for understanding variable reporting patterns in vaccine literature, supporting academic tracking without referencing active monitoring systems.

02

Related GIDS surveillance

Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.

03

Evidence relationships

This article has 11 auditable classifier relationships to diseases, places, topics, and study design.

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