Rapid protective effects of early BCG on neonatal mortality among low birth weight boys: Observations from randomized trials

Sofie Biering-Sørensen, Kristoffer Jarlov Jensen, Ivan Monterio, Henrik Ravn, Peter Aaby, Christine Stabell Benn

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

131 Downloads (Pure)

Resumé

Background. Three randomized trials (RCTs) in low-weight (<2.5 kg) infants have shown that Bacille Calmette-Guérin (BCG) vaccine nonspecifically reduces all-cause mortality in the neonatal period. Methods. Using data from 3 RCTs of early BCG (n = 6583) we examined potential sex differences in the timing of the mortality reduction in the neonatal period, presenting metaestimates of the main outcome mortality rate ratios (MRR) for BCG-vaccinated and controls. Results. Among controls, boys had a particularly high mortality during the first week after randomization: male-female MRR 2.71 (95% CI, 1.70-4.50). During the first week, BCG had a marked beneficial effect for boys, reducing mortality 3-fold (MRR [BCG/ no BCG] = 0.36 [0.20-0.67]). In weeks 2-4 the effect waned for boys (MRR = 0.91 [0.51-1.69]). In girls, the pattern was opposite with a limited effect in the first week (MRR = 0.85 [0.46-1.54]), but a significant reduction in weeks 2-4 (MRR = 0.56 [0.31-1.00]). This was consistent in all 3 trials. Verbal autopsies linked early benefit to fewer sepsis-related deaths among BCG-vaccinated boys. Discussion. The marked reduction in mortality in the days after BCG vaccination in boys emphasizes the importance of providing BCG soon after birth.

OriginalsprogEngelsk
TidsskriftJournal of Infectious Diseases
Vol/bind217
Udgave nummer5
Sider (fra-til)759–766
ISSN0022-1899
DOI
StatusUdgivet - 14. feb. 2018

Fingeraftryk

Low Birth Weight Infant
Random Allocation
Sex Characteristics
Weights and Measures

Citer dette

@article{de87d89aa5be48ae96c57ac5d989aca2,
title = "Rapid protective effects of early BCG on neonatal mortality among low birth weight boys: Observations from randomized trials",
abstract = "Background. Three randomized trials (RCTs) in low-weight (<2.5 kg) infants have shown that Bacille Calmette-Gu{\'e}rin (BCG) vaccine nonspecifically reduces all-cause mortality in the neonatal period. Methods. Using data from 3 RCTs of early BCG (n = 6583) we examined potential sex differences in the timing of the mortality reduction in the neonatal period, presenting metaestimates of the main outcome mortality rate ratios (MRR) for BCG-vaccinated and controls. Results. Among controls, boys had a particularly high mortality during the first week after randomization: male-female MRR 2.71 (95{\%} CI, 1.70-4.50). During the first week, BCG had a marked beneficial effect for boys, reducing mortality 3-fold (MRR [BCG/ no BCG] = 0.36 [0.20-0.67]). In weeks 2-4 the effect waned for boys (MRR = 0.91 [0.51-1.69]). In girls, the pattern was opposite with a limited effect in the first week (MRR = 0.85 [0.46-1.54]), but a significant reduction in weeks 2-4 (MRR = 0.56 [0.31-1.00]). This was consistent in all 3 trials. Verbal autopsies linked early benefit to fewer sepsis-related deaths among BCG-vaccinated boys. Discussion. The marked reduction in mortality in the days after BCG vaccination in boys emphasizes the importance of providing BCG soon after birth.",
keywords = "Journal Article, Neonatal mortality, Nonspecific effects of vaccines, Sex differences, Bacille Calmette-Gu{\'e}rin vaccine, Heterologous immunity, Infant, Low Birth Weight, Age Factors, Infant Mortality, Humans, Infant, Male, Treatment Outcome, Randomized Controlled Trials as Topic, BCG Vaccine/administration & dosage, Sex Factors, Female, Infant, Newborn",
author = "Sofie Biering-S{\o}rensen and Jensen, {Kristoffer Jarlov} and Ivan Monterio and Henrik Ravn and Peter Aaby and Benn, {Christine Stabell}",
year = "2018",
month = "2",
day = "14",
doi = "10.1093/infdis/jix612",
language = "English",
volume = "217",
pages = "759–766",
journal = "Journal of Infectious Diseases",
issn = "0022-1899",
publisher = "Heinemann",
number = "5",

}

Rapid protective effects of early BCG on neonatal mortality among low birth weight boys : Observations from randomized trials. / Biering-Sørensen, Sofie; Jensen, Kristoffer Jarlov; Monterio, Ivan; Ravn, Henrik; Aaby, Peter; Benn, Christine Stabell.

I: Journal of Infectious Diseases, Bind 217, Nr. 5, 14.02.2018, s. 759–766.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Rapid protective effects of early BCG on neonatal mortality among low birth weight boys

T2 - Observations from randomized trials

AU - Biering-Sørensen, Sofie

AU - Jensen, Kristoffer Jarlov

AU - Monterio, Ivan

AU - Ravn, Henrik

AU - Aaby, Peter

AU - Benn, Christine Stabell

PY - 2018/2/14

Y1 - 2018/2/14

N2 - Background. Three randomized trials (RCTs) in low-weight (<2.5 kg) infants have shown that Bacille Calmette-Guérin (BCG) vaccine nonspecifically reduces all-cause mortality in the neonatal period. Methods. Using data from 3 RCTs of early BCG (n = 6583) we examined potential sex differences in the timing of the mortality reduction in the neonatal period, presenting metaestimates of the main outcome mortality rate ratios (MRR) for BCG-vaccinated and controls. Results. Among controls, boys had a particularly high mortality during the first week after randomization: male-female MRR 2.71 (95% CI, 1.70-4.50). During the first week, BCG had a marked beneficial effect for boys, reducing mortality 3-fold (MRR [BCG/ no BCG] = 0.36 [0.20-0.67]). In weeks 2-4 the effect waned for boys (MRR = 0.91 [0.51-1.69]). In girls, the pattern was opposite with a limited effect in the first week (MRR = 0.85 [0.46-1.54]), but a significant reduction in weeks 2-4 (MRR = 0.56 [0.31-1.00]). This was consistent in all 3 trials. Verbal autopsies linked early benefit to fewer sepsis-related deaths among BCG-vaccinated boys. Discussion. The marked reduction in mortality in the days after BCG vaccination in boys emphasizes the importance of providing BCG soon after birth.

AB - Background. Three randomized trials (RCTs) in low-weight (<2.5 kg) infants have shown that Bacille Calmette-Guérin (BCG) vaccine nonspecifically reduces all-cause mortality in the neonatal period. Methods. Using data from 3 RCTs of early BCG (n = 6583) we examined potential sex differences in the timing of the mortality reduction in the neonatal period, presenting metaestimates of the main outcome mortality rate ratios (MRR) for BCG-vaccinated and controls. Results. Among controls, boys had a particularly high mortality during the first week after randomization: male-female MRR 2.71 (95% CI, 1.70-4.50). During the first week, BCG had a marked beneficial effect for boys, reducing mortality 3-fold (MRR [BCG/ no BCG] = 0.36 [0.20-0.67]). In weeks 2-4 the effect waned for boys (MRR = 0.91 [0.51-1.69]). In girls, the pattern was opposite with a limited effect in the first week (MRR = 0.85 [0.46-1.54]), but a significant reduction in weeks 2-4 (MRR = 0.56 [0.31-1.00]). This was consistent in all 3 trials. Verbal autopsies linked early benefit to fewer sepsis-related deaths among BCG-vaccinated boys. Discussion. The marked reduction in mortality in the days after BCG vaccination in boys emphasizes the importance of providing BCG soon after birth.

KW - Journal Article

KW - Neonatal mortality

KW - Nonspecific effects of vaccines

KW - Sex differences

KW - Bacille Calmette-Guérin vaccine

KW - Heterologous immunity

KW - Infant, Low Birth Weight

KW - Age Factors

KW - Infant Mortality

KW - Humans

KW - Infant

KW - Male

KW - Treatment Outcome

KW - Randomized Controlled Trials as Topic

KW - BCG Vaccine/administration & dosage

KW - Sex Factors

KW - Female

KW - Infant, Newborn

U2 - 10.1093/infdis/jix612

DO - 10.1093/infdis/jix612

M3 - Journal article

C2 - 29216358

VL - 217

SP - 759

EP - 766

JO - Journal of Infectious Diseases

JF - Journal of Infectious Diseases

SN - 0022-1899

IS - 5

ER -