Nonspecific effect of BCG vaccination at birth on early childhood infections: a randomized, clinical multicenter trial

Jesper Kjærgaard; Nina Marie Birk; Thomas N Nissen; Lisbeth Marianne Thøstesen; Gitte Thybo Pihl; Christine S Benn; Dorthe L Jeppesen; Ole Pryds; Poul-Erik Kofoed; Peter Aaby; Gorm Greisen; Lone G Stensballe

doi:10.1038/pr.2016.142

Nonspecific effect of BCG vaccination at birth on early childhood infections: a randomized, clinical multicenter trial

Jesper Kjærgaard, Nina Marie Birk, Thomas N Nissen, Lisbeth Marianne Thøstesen, Gitte Thybo Pihl, Christine S Benn, Dorthe L Jeppesen, Ole Pryds, Poul-Erik Kofoed, Peter Aaby, Gorm Greisen, Lone G Stensballe

25 Citationer (Scopus)

Abstract

BACKGROUND: Childhood infections are common and Bacillus Calmette-Guérin (BCG) vaccination at birth may prevent these via nonspecific effects.

METHODS: A randomized, clinical multicenter trial. All women planning to give birth (n = 16,521) at the three study sites were invited during the recruitment period. Participating children were randomized to receive BCG within 7 d of birth or to a no intervention control group. Parent-reported infections (events) were collected using telephone interviews at 3 and 13 mo. Data collectors were blinded to allocation.

RESULTS: The analyses included 4,224/4,262 (99%) and 4,192/4,262 (98%) children at 3 and 13 mo. From 0 to 3 mo, there were 291 events in the BCG group vs. 336 events in the control group, incidence rate ratio (IRR) = 0.87 (95% confidence interval (CI): 0.72 to 1.05). In this age group, the IRR was 0.62 (95% CI: 0.39 to 0.98) if the mother was BCG vaccinated. From 3 to 13 mo, there were 7,028 vs. 6,791 events, IRR = 1.02 (95% CI: 0.97 to 1.07).

CONCLUSION: This study did not find a nonspecific public health benefit of BCG on parent-reported infections. BCG may have reduced the incidence of infections in children of BCG-vaccinated mothers during the first 3 mo.

Originalsprog	Engelsk
Tidsskrift	Pediatric Research
Vol/bind	80
Udgave nummer	5
Sider (fra-til)	681-685
Antal sider	5
ISSN	0031-3998
DOI	https://doi.org/10.1038/pr.2016.142
Status	Udgivet - 1 nov. 2016

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Kjærgaard, J., Birk, N. M., Nissen, T. N., Thøstesen, L. M., Pihl, G. T., Benn, C. S., Jeppesen, D. L., Pryds, O., Kofoed, P-E., Aaby, P., Greisen, G., & Stensballe, L. G. (2016). Nonspecific effect of BCG vaccination at birth on early childhood infections: a randomized, clinical multicenter trial. Pediatric Research, 80(5), 681-685. https://doi.org/10.1038/pr.2016.142

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abstract = "BACKGROUND: Childhood infections are common and Bacillus Calmette-Gu{\'e}rin (BCG) vaccination at birth may prevent these via nonspecific effects.METHODS: A randomized, clinical multicenter trial. All women planning to give birth (n = 16,521) at the three study sites were invited during the recruitment period. Participating children were randomized to receive BCG within 7 d of birth or to a no intervention control group. Parent-reported infections (events) were collected using telephone interviews at 3 and 13 mo. Data collectors were blinded to allocation.RESULTS: The analyses included 4,224/4,262 (99%) and 4,192/4,262 (98%) children at 3 and 13 mo. From 0 to 3 mo, there were 291 events in the BCG group vs. 336 events in the control group, incidence rate ratio (IRR) = 0.87 (95% confidence interval (CI): 0.72 to 1.05). In this age group, the IRR was 0.62 (95% CI: 0.39 to 0.98) if the mother was BCG vaccinated. From 3 to 13 mo, there were 7,028 vs. 6,791 events, IRR = 1.02 (95% CI: 0.97 to 1.07).CONCLUSION: This study did not find a nonspecific public health benefit of BCG on parent-reported infections. BCG may have reduced the incidence of infections in children of BCG-vaccinated mothers during the first 3 mo.",

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author = "Jesper Kj{\ae}rgaard and Birk, {Nina Marie} and Nissen, {Thomas N} and Th{\o}stesen, {Lisbeth Marianne} and Pihl, {Gitte Thybo} and Benn, {Christine S} and Jeppesen, {Dorthe L} and Ole Pryds and Poul-Erik Kofoed and Peter Aaby and Gorm Greisen and Stensballe, {Lone G}",

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doi = "10.1038/pr.2016.142",

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AU - Kjærgaard, Jesper

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AU - Nissen, Thomas N

AU - Thøstesen, Lisbeth Marianne

AU - Pihl, Gitte Thybo

AU - Benn, Christine S

AU - Jeppesen, Dorthe L

AU - Pryds, Ole

AU - Kofoed, Poul-Erik

AU - Aaby, Peter

AU - Greisen, Gorm

AU - Stensballe, Lone G

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N2 - BACKGROUND: Childhood infections are common and Bacillus Calmette-Guérin (BCG) vaccination at birth may prevent these via nonspecific effects.METHODS: A randomized, clinical multicenter trial. All women planning to give birth (n = 16,521) at the three study sites were invited during the recruitment period. Participating children were randomized to receive BCG within 7 d of birth or to a no intervention control group. Parent-reported infections (events) were collected using telephone interviews at 3 and 13 mo. Data collectors were blinded to allocation.RESULTS: The analyses included 4,224/4,262 (99%) and 4,192/4,262 (98%) children at 3 and 13 mo. From 0 to 3 mo, there were 291 events in the BCG group vs. 336 events in the control group, incidence rate ratio (IRR) = 0.87 (95% confidence interval (CI): 0.72 to 1.05). In this age group, the IRR was 0.62 (95% CI: 0.39 to 0.98) if the mother was BCG vaccinated. From 3 to 13 mo, there were 7,028 vs. 6,791 events, IRR = 1.02 (95% CI: 0.97 to 1.07).CONCLUSION: This study did not find a nonspecific public health benefit of BCG on parent-reported infections. BCG may have reduced the incidence of infections in children of BCG-vaccinated mothers during the first 3 mo.

AB - BACKGROUND: Childhood infections are common and Bacillus Calmette-Guérin (BCG) vaccination at birth may prevent these via nonspecific effects.METHODS: A randomized, clinical multicenter trial. All women planning to give birth (n = 16,521) at the three study sites were invited during the recruitment period. Participating children were randomized to receive BCG within 7 d of birth or to a no intervention control group. Parent-reported infections (events) were collected using telephone interviews at 3 and 13 mo. Data collectors were blinded to allocation.RESULTS: The analyses included 4,224/4,262 (99%) and 4,192/4,262 (98%) children at 3 and 13 mo. From 0 to 3 mo, there were 291 events in the BCG group vs. 336 events in the control group, incidence rate ratio (IRR) = 0.87 (95% confidence interval (CI): 0.72 to 1.05). In this age group, the IRR was 0.62 (95% CI: 0.39 to 0.98) if the mother was BCG vaccinated. From 3 to 13 mo, there were 7,028 vs. 6,791 events, IRR = 1.02 (95% CI: 0.97 to 1.07).CONCLUSION: This study did not find a nonspecific public health benefit of BCG on parent-reported infections. BCG may have reduced the incidence of infections in children of BCG-vaccinated mothers during the first 3 mo.

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JF - Pediatric Research

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Nonspecific effect of BCG vaccination at birth on early childhood infections: a randomized, clinical multicenter trial

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