Bacille Calmette-Guérin (BCG) vaccination at birth and antibody responses to childhood vaccines

A randomised clinical trial

The Calmette Study Group

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

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Resumé

Introduction BCG vaccination has been associated with beneficial non-specific effects on child health. Some immunological studies have reported heterologous effects of vaccines on antibody responses to heterologous vaccines. Within a randomised clinical trial of Bacille Calmette-Guérin (BCG) vaccination at birth, The Danish Calmette Study, we investigated the effect of BCG at birth on the antibody response to the three routine vaccines against DiTeKiPol/Act-Hib and Prevenar 13 in a subgroup of participants. Methods Within 7 days after birth, children were randomised 1:1 to BCG vaccination or to the control group (no intervention). After three routine vaccinations given at age 3, 5 and 12 months, antibodies against DiTeKiPol/Act-Hib and Prevenar 13 (Streptococcus pneumoniae serotype type 4, 6B, 9V, 14, 18C, 19F and 23F) were measured 4 weeks after the third vaccine dose. Results Among the 300 included children (178 BCG; 122 controls), almost all children (>96%) had antibody responses above the protective levels. Overall BCG vaccination at birth did not affect the antibody level. When stratifying by ‘age at randomisation’ we found a possible inducing effect of BCG on antibodies against B. pertussis and all pneumococcal serotypes, when BCG was given after the first day of life. Girls had significantly higher antibody levels for Haemophilus influenza type b and pneumococcus than boys. Conclusions and relevance Three routine vaccinations with DiTeKiPol/Act-Hib and Prevenar 13 induced sero-protective levels in almost all children. No overall effect of neonatal BCG vaccination was observed.

OriginalsprogEngelsk
TidsskriftVaccine
Vol/bind35
Udgave nummer16
Sider (fra-til)2084-2091
ISSN0264-410X
DOI
StatusUdgivet - 2017

Fingeraftryk

randomized clinical trials
childhood
Randomized Controlled Trials
vaccination
Haemophilus influenzae type b
vaccines
antibodies
serotypes
childbirth
Haemophilus influenzae
Streptococcus pneumoniae
Whooping Cough
Random Allocation
Control Groups
dosage

Citer dette

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title = "Bacille Calmette-Gu{\'e}rin (BCG) vaccination at birth and antibody responses to childhood vaccines: A randomised clinical trial",
abstract = "Introduction BCG vaccination has been associated with beneficial non-specific effects on child health. Some immunological studies have reported heterologous effects of vaccines on antibody responses to heterologous vaccines. Within a randomised clinical trial of Bacille Calmette-Gu{\'e}rin (BCG) vaccination at birth, The Danish Calmette Study, we investigated the effect of BCG at birth on the antibody response to the three routine vaccines against DiTeKiPol/Act-Hib and Prevenar 13 in a subgroup of participants. Methods Within 7 days after birth, children were randomised 1:1 to BCG vaccination or to the control group (no intervention). After three routine vaccinations given at age 3, 5 and 12 months, antibodies against DiTeKiPol/Act-Hib and Prevenar 13 (Streptococcus pneumoniae serotype type 4, 6B, 9V, 14, 18C, 19F and 23F) were measured 4 weeks after the third vaccine dose. Results Among the 300 included children (178 BCG; 122 controls), almost all children (>96{\%}) had antibody responses above the protective levels. Overall BCG vaccination at birth did not affect the antibody level. When stratifying by ‘age at randomisation’ we found a possible inducing effect of BCG on antibodies against B. pertussis and all pneumococcal serotypes, when BCG was given after the first day of life. Girls had significantly higher antibody levels for Haemophilus influenza type b and pneumococcus than boys. Conclusions and relevance Three routine vaccinations with DiTeKiPol/Act-Hib and Prevenar 13 induced sero-protective levels in almost all children. No overall effect of neonatal BCG vaccination was observed.",
keywords = "BCG, Children, Clinical trial, Heterologous immunity, Non-specific effects, Vaccine antibodies",
author = "Nissen, {Thomas N{\o}rrelykke} and Birk, {Nina Marie} and Gaby Smits and Jeppesen, {Dorthe Lisbeth} and Stensballe, {Lone Graff} and Netea, {Mihai G} and {van der Klis}, Fiona and Benn, {Christine Stabell} and Ole Pryds and {The Calmette Study Group} and Andreas Andersen and Jesper Kj{\ae}rgaard and Th{\o}stesen, {Lisbeth Marianne} and Pihl, {Gitte Thybo} and Thomas Hoffmann and Kofoed, {Poul Erik} and Peter Aaby",
year = "2017",
doi = "10.1016/j.vaccine.2017.02.048",
language = "English",
volume = "35",
pages = "2084--2091",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier",
number = "16",

}

Bacille Calmette-Guérin (BCG) vaccination at birth and antibody responses to childhood vaccines : A randomised clinical trial. / The Calmette Study Group.

I: Vaccine, Bind 35, Nr. 16, 2017, s. 2084-2091.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Bacille Calmette-Guérin (BCG) vaccination at birth and antibody responses to childhood vaccines

T2 - A randomised clinical trial

AU - Nissen, Thomas Nørrelykke

AU - Birk, Nina Marie

AU - Smits, Gaby

AU - Jeppesen, Dorthe Lisbeth

AU - Stensballe, Lone Graff

AU - Netea, Mihai G

AU - van der Klis, Fiona

AU - Benn, Christine Stabell

AU - Pryds, Ole

AU - The Calmette Study Group

A2 - Andersen, Andreas

A2 - Kjærgaard, Jesper

A2 - Thøstesen, Lisbeth Marianne

A2 - Pihl, Gitte Thybo

A2 - Hoffmann, Thomas

A2 - Kofoed, Poul Erik

A2 - Aaby, Peter

PY - 2017

Y1 - 2017

N2 - Introduction BCG vaccination has been associated with beneficial non-specific effects on child health. Some immunological studies have reported heterologous effects of vaccines on antibody responses to heterologous vaccines. Within a randomised clinical trial of Bacille Calmette-Guérin (BCG) vaccination at birth, The Danish Calmette Study, we investigated the effect of BCG at birth on the antibody response to the three routine vaccines against DiTeKiPol/Act-Hib and Prevenar 13 in a subgroup of participants. Methods Within 7 days after birth, children were randomised 1:1 to BCG vaccination or to the control group (no intervention). After three routine vaccinations given at age 3, 5 and 12 months, antibodies against DiTeKiPol/Act-Hib and Prevenar 13 (Streptococcus pneumoniae serotype type 4, 6B, 9V, 14, 18C, 19F and 23F) were measured 4 weeks after the third vaccine dose. Results Among the 300 included children (178 BCG; 122 controls), almost all children (>96%) had antibody responses above the protective levels. Overall BCG vaccination at birth did not affect the antibody level. When stratifying by ‘age at randomisation’ we found a possible inducing effect of BCG on antibodies against B. pertussis and all pneumococcal serotypes, when BCG was given after the first day of life. Girls had significantly higher antibody levels for Haemophilus influenza type b and pneumococcus than boys. Conclusions and relevance Three routine vaccinations with DiTeKiPol/Act-Hib and Prevenar 13 induced sero-protective levels in almost all children. No overall effect of neonatal BCG vaccination was observed.

AB - Introduction BCG vaccination has been associated with beneficial non-specific effects on child health. Some immunological studies have reported heterologous effects of vaccines on antibody responses to heterologous vaccines. Within a randomised clinical trial of Bacille Calmette-Guérin (BCG) vaccination at birth, The Danish Calmette Study, we investigated the effect of BCG at birth on the antibody response to the three routine vaccines against DiTeKiPol/Act-Hib and Prevenar 13 in a subgroup of participants. Methods Within 7 days after birth, children were randomised 1:1 to BCG vaccination or to the control group (no intervention). After three routine vaccinations given at age 3, 5 and 12 months, antibodies against DiTeKiPol/Act-Hib and Prevenar 13 (Streptococcus pneumoniae serotype type 4, 6B, 9V, 14, 18C, 19F and 23F) were measured 4 weeks after the third vaccine dose. Results Among the 300 included children (178 BCG; 122 controls), almost all children (>96%) had antibody responses above the protective levels. Overall BCG vaccination at birth did not affect the antibody level. When stratifying by ‘age at randomisation’ we found a possible inducing effect of BCG on antibodies against B. pertussis and all pneumococcal serotypes, when BCG was given after the first day of life. Girls had significantly higher antibody levels for Haemophilus influenza type b and pneumococcus than boys. Conclusions and relevance Three routine vaccinations with DiTeKiPol/Act-Hib and Prevenar 13 induced sero-protective levels in almost all children. No overall effect of neonatal BCG vaccination was observed.

KW - BCG

KW - Children

KW - Clinical trial

KW - Heterologous immunity

KW - Non-specific effects

KW - Vaccine antibodies

U2 - 10.1016/j.vaccine.2017.02.048

DO - 10.1016/j.vaccine.2017.02.048

M3 - Journal article

VL - 35

SP - 2084

EP - 2091

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - 16

ER -