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

Randomized trials assessing BCG vaccine protection against tuberculosis have widely varying results, for reasons that are not well understood. We examined associations of trial setting and design with BCG efficacy against pulmonary and miliary or meningeal tuberculosis by conducting a systematic rev...

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Vydané v:	Clinical infectious diseases Ročník 58; číslo 4; s. 470
Hlavní autori:	Mangtani, Punam, Abubakar, Ibrahim, Ariti, Cono, Beynon, Rebecca, Pimpin, Laura, Fine, Paul E M, Rodrigues, Laura C, Smith, Peter G, Lipman, Marc, Whiting, Penny F, Sterne, Jonathan A
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	United States 15.02.2014
Predmet:	BCG Vaccine - administration & dosage BCG Vaccine - immunology Humans Randomized Controlled Trials as Topic Treatment Outcome Tuberculosis, Meningeal - epidemiology Tuberculosis, Meningeal - prevention & control Tuberculosis, Miliary - epidemiology Tuberculosis, Miliary - prevention & control Tuberculosis, Pulmonary - epidemiology Tuberculosis, Pulmonary - prevention & control meta-analysis trials vaccine efficacy BCG vaccine meta-regression
ISSN:	1537-6591, 1537-6591
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Abstract	Randomized trials assessing BCG vaccine protection against tuberculosis have widely varying results, for reasons that are not well understood. 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. 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). 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.
AbstractList	Randomized trials assessing BCG vaccine protection against tuberculosis have widely varying results, for reasons that are not well understood. 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. 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). 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. Randomized trials assessing BCG vaccine protection against tuberculosis have widely varying results, for reasons that are not well understood.BACKGROUNDRandomized trials assessing BCG vaccine protection against tuberculosis have widely varying results, for reasons that are not well understood.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.METHODSWe 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.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).RESULTSWe 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).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.CONCLUSIONSAbsence 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.
Author	Abubakar, Ibrahim Smith, Peter G Whiting, Penny F Beynon, Rebecca Sterne, Jonathan A Pimpin, Laura Ariti, Cono Fine, Paul E M Lipman, Marc Rodrigues, Laura C Mangtani, Punam
Author_xml	– sequence: 1 givenname: Punam surname: Mangtani fullname: Mangtani, Punam organization: Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine – sequence: 2 givenname: Ibrahim surname: Abubakar fullname: Abubakar, Ibrahim – sequence: 3 givenname: Cono surname: Ariti fullname: Ariti, Cono – sequence: 4 givenname: Rebecca surname: Beynon fullname: Beynon, Rebecca – sequence: 5 givenname: Laura surname: Pimpin fullname: Pimpin, Laura – sequence: 6 givenname: Paul E M surname: Fine fullname: Fine, Paul E M – sequence: 7 givenname: Laura C surname: Rodrigues fullname: Rodrigues, Laura C – sequence: 8 givenname: Peter G surname: Smith fullname: Smith, Peter G – sequence: 9 givenname: Marc surname: Lipman fullname: Lipman, Marc – sequence: 10 givenname: Penny F surname: Whiting fullname: Whiting, Penny F – sequence: 11 givenname: Jonathan A surname: Sterne fullname: Sterne, Jonathan A
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/24336911$$D View this record in MEDLINE/PubMed
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References	24803373 - Clin Infect Dis. 2014 Aug 15;59(4):607-8. doi: 10.1093/cid/ciu331. 24803378 - Clin Infect Dis. 2014 Aug 15;59(4):608-9. doi: 10.1093/cid/ciu330. 24803374 - Clin Infect Dis. 2014 Aug 15;59(4):605-7. doi: 10.1093/cid/ciu329. 24336910 - Clin Infect Dis. 2014 Feb;58(4):481-2. doi: 10.1093/cid/cit793.
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Snippet	Randomized trials assessing BCG vaccine protection against tuberculosis have widely varying results, for reasons that are not well understood. We examined... Randomized trials assessing BCG vaccine protection against tuberculosis have widely varying results, for reasons that are not well...
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SubjectTerms	BCG Vaccine - administration & dosage BCG Vaccine - immunology Humans Randomized Controlled Trials as Topic Treatment Outcome Tuberculosis, Meningeal - epidemiology Tuberculosis, Meningeal - prevention & control Tuberculosis, Miliary - epidemiology Tuberculosis, Miliary - prevention & control Tuberculosis, Pulmonary - epidemiology Tuberculosis, Pulmonary - prevention & control
Title	Protection by BCG vaccine against tuberculosis: a systematic review of randomized controlled trials
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