Thomas Nørrelykke Nissen1, Nina Marie Birk2, Gaby Smits3, Dorthe Lisbeth Jeppesen4, Lone Graff Stensballe5, Mihai G Netea6, Fiona van der Klis7, Christine Stabell Benn8, Ole Pryds9. 1. Department of Pediatrics, 460, Copenhagen University Hospital, Hvidovre, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark. Electronic address: thomas.nissen@dadlnet.dk. 2. Department of Pediatrics, 460, Copenhagen University Hospital, Hvidovre, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark. Electronic address: ninabirk@dadlnet.dk. 3. National Institute for Public health and the Environment, Centre for Infectious Disease Control, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, The Netherlands. Electronic address: gaby.smits@rivm.nl. 4. Department of Pediatrics, 460, Copenhagen University Hospital, Hvidovre, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark. Electronic address: Dorthe.Lisbeth.Jeppesen@regionh.dk. 5. The Child and Adolescent Clinic 4072, Juliane Marie Centret, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, DK-2100 Copenhagen Ø, Denmark. Electronic address: Lone.graff.stensballe@regionh.dk. 6. Division of Experimental Internal Medicine, Department of Internal Medicine, Radboud University Medical Center, Geert Grooteplein 10, 6525GA Nijmegen, The Netherlands. Electronic address: Mihai.Netea@radboudumc.nl. 7. National Institute for Public health and the Environment, Centre for Infectious Disease Control, Antonie van Leeuwenhoeklaan 9, 3721 MA Bilthoven, The Netherlands. Electronic address: fiona.van.der.klis@rivm.nl. 8. Research Center for Vitamins and Vaccines (CVIVA), Bandim Health Project, Statens Serum Institut, Artillerivej 5, DK-2300 Copenhagen S, Denmark; Odense Patient data Explorative Network, Odense University Hospital/Institute of Clinical Research, University of Southern Denmark, Odense, Denmark. Electronic address: cb@ssi.dk. 9. Department of Pediatrics, 460, Copenhagen University Hospital, Hvidovre, Kettegaard Allé 30, DK-2650 Hvidovre, Denmark. Electronic address: pryds@dadlnet.dk.
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-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 7days 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 12months, antibodies against DiTeKiPol/Act-Hib and Prevenar 13 (Streptococcus pneumoniae serotype type 4, 6B, 9V, 14, 18C, 19F and 23F) were measured 4weeks 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.
RCT Entities:
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 7days 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 12months, antibodies against DiTeKiPol/Act-Hib and Prevenar 13 (Streptococcus pneumoniae serotype type 4, 6B, 9V, 14, 18C, 19F and 23F) were measured 4weeks 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.
Authors: Francesca Schiaffino; Gwenyth O Lee; Maribel Paredes-Olortegui; Lilia Cabrera; Pablo Penataro-Yori; Robert H Gilman; Margaret N Kosek Journal: Am J Perinatol Date: 2018-12-24 Impact factor: 1.862
Authors: T N Nissen; N M Birk; B A Blok; R J W Arts; A Andersen; J Kjærgaard; L M Thøstesen; T Hoffmann; D L Jeppesen; S D Nielsen; P-E Kofoed; L G Stensballe; P Aaby; M Ruhwald; M G Netea; C S Benn; O Pryds Journal: Eur J Clin Microbiol Infect Dis Date: 2017-09-10 Impact factor: 3.267
Authors: Nina Marie Birk; Thomas Nørrelykke Nissen; Jesper Kjærgaard; Hans Jacob Hartling; Lisbeth Marianne Thøstesen; Poul-Erik Kofoed; Lone Graff Stensballe; Andreas Andersen; Ole Pryds; Mihai G Netea; Christine Stabell Benn; Susanne Dam Nielsen; Dorthe Lisbeth Jeppesen Journal: Sci Rep Date: 2017-09-29 Impact factor: 4.379