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Cited by 995Tuberculosis Research and EpidemiologyImmune responses and vaccinationsInfectious Diseases and Tuberculosis

Protection by BCG vaccine against tuberculosis: a systematic review of randomized controlled trials

Mangtani, Punam, Abubakar, Ibrahim, Ariti, Cono, Beynon, Rebecca, Pimpin, Laura, Fine, Paul E. M., Rodrigues, Laura C., Smith, Peter G. +3 more·2014·Clinical Infectious Diseases
DOI 10.1093/cid/cit790
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Abstract

BACKGROUND: Randomized trials assessing BCG vaccine protection against tuberculosis have widely varying results, for reasons that are not well understood. METHODS: We examined associations of trial setting and design with BCG efficacy against pulmonary and miliary or meningeal tuberculosis by conducting a systematic review, meta-analyses, and meta-regression. RESULTS: We identified 18 trials reporting pulmonary tuberculosis and 6 reporting miliary or meningeal tuberculosis. Univariable meta-regression indicated efficacy against pulmonary tuberculosis varied according to 3 characteristics. Protection appeared greatest in children stringently tuberculin tested, to try to exclude prior infection with Mycobacterium tuberculosis or sensitization to environmental mycobacteria (rate ratio [RR], 0.26; 95% confidence interval [CI], .18-.37), or infants (RR, 0.41; 95% CI, .29-.58). Protection was weaker in children not stringently tested (RR, 0.59; 95% CI, .35-1.01) and older individuals stringently or not stringently tested (RR, 0.88; 95% CI, .59-1.31 and RR, 0.81; 95% CI, .55-1.22, respectively). Protection was higher in trials further from the equator where environmental mycobacteria are less and with lower risk of diagnostic detection bias. These associations were attenuated in a multivariable model, but each had an independent effect. There was no evidence that efficacy was associated with BCG strain. Protection against meningeal and miliary tuberculosis was also high in infants (RR, 0.1; 95% CI, .01-.77) and children stringently tuberculin tested (RR, 0.08; 95% CI, .03-.25). CONCLUSIONS: Absence of prior M. tuberculosis infection or sensitization with environmental mycobacteria is associated with higher efficacy of BCG against pulmonary tuberculosis and possibly against miliary and meningeal tuberculosis. Evaluations of new tuberculosis vaccines should account for the possibility that prior infection may mask or block their effects.

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Authors
Mangtani, P., Abubakar, I., Ariti, C., Beynon, R., Pimpin, L., Fine, P. E. M., Rodrigues, L. C., Smith, P. G., Lipman, M., Whiting, P. F., & Sterne, J. A.
Affiliations
  • London School of Hygiene & Tropical Medicine (GB)
  • Public Health England (GB)
  • University of Bristol (GB)
  • MRC Elsie Widdowson Laboratory (GB)
  • The Royal Free Hospital (GB)
Corresponding author
Mangtani, Punam
ORCID
Venue
Clinical Infectious Diseases
Publisher
Oxford University Press (OUP)
Published
2013-12-13
Volume
58
Issue
4
Pages
470-480
ISSN
  • 1058-4838 (ISSN-L)
  • 1537-6591
DOI
10.1093/cid/cit790
OpenAlex
W2010318115
Cited by
995
References
41
Citations by year
2026: 70 · 2025: 89 · 2024: 89 · 2023: 81 · 2022: 97 · 2021: 116 · 2020: 93 · 2019: 85 · 2018: 77 · 2017: 68 · 2016: 54 · 2015: 47 · 2014: 26
FWCI
5.38
Type
journal article
Language
en
Open access
closed
Locations
  • Clinical Infectious Diseases (publishedVersion)
  • PubMed (publishedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
  • UCL Discovery (University College London) (submittedVersion)
  • Bristol Research (University of Bristol) (submittedVersion)
Funders
  • London School of Hygiene and Tropical Medicine
  • National Institute for Health and Care Research (NF-SI-0611-10168, 08/17/01, 08/16/01)
  • University of Bristol
  • Medical Research Council (MR/K012126/1)
Topics
  • Health Sciences › Medicine › Infectious Diseases › Tuberculosis Research and Epidemiology
  • Life Sciences › Immunology and Microbiology › Immunology › Immune responses and vaccinations
  • Health Sciences › Medicine › Surgery › Infectious Diseases and Tuberculosis
Keywords
BCG vaccine, tuberculosis vaccine efficacy, pulmonary tuberculosis, miliary tuberculosis, tuberculous meningitis, tuberculin skin test, infants, vaccine trial design
MeSH terms
BCG Vaccine, Humans, Tuberculosis, Meningeal, Tuberculosis, Miliary, Tuberculosis, Pulmonary, Randomized Controlled Trials as Topic, Treatment Outcome

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