Variation of growth in the production of the BCG vaccine and the association with the immune response. An observational study within a randomised trial

Vaccine

Volumn 33, Issue 17, 2015, Pages 2056-2065

  Biering Sørensen, Sofie ^a,b   Jensen, Kristoffer Jarlov ^a,b,c   Aamand, Susanne Havn ^a   Blok, Bastiaan ^d   Andersen, Andreas ^a,b   Monteiro, Ivan ^b   Netea, Mihai G ^d   Aaby, Peter ^b   Benn, Christine Stabell ^a,e   Hasløv, Kaare Robert ^a  

^a STATENS SERUM INSTITUT   (Denmark)

^b Studies of the Epidemiology of Epilepsy in Demographic Surveillance Systems   (Guinea-Bissau)

^c UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

^d RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^e UNIVERSITY OF SOUTHERN DENMARK   (Denmark)

Author keywords

Bacillus Calmette Gu rin; Cytokine; Heterologous immunity; Immunogenicity; Infant; Tuberculin PPD; Vaccine production

Indexed keywords

BCG VACCINE; INTERLEUKIN 6; TUMOR NECROSIS FACTOR ALPHA; CYTOKINE; INTERLEUKIN 10; TNF PROTEIN, HUMAN;

ARTICLE; BCG VACCINATION; CHILD HOSPITALIZATION; CONTROLLED STUDY; CYTOKINE RESPONSE; DRUG FEVER; FEMALE; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; IN VITRO STUDY; IN VIVO STUDY; INNATE IMMUNITY; LYMPHADENOPATHY; MAJOR CLINICAL STUDY; MALE; NEWBORN; OBSERVATIONAL STUDY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCAR; SCAR FORMATION; SKIN ABSCESS; TUBERCULIN TEST; TUBERCULOSIS; VACCINE PRODUCTION; FOLLOW UP; GROWTH, DEVELOPMENT AND AGING; IMMUNOLOGY; INFANT; LOW BIRTH WEIGHT; MONOCYTE; MYCOBACTERIUM BOVIS; STANDARDS; TIME;

BCG VACCINE; CYTOKINES; FEMALE; FOLLOW-UP STUDIES; HUMANS; INFANT; INFANT, LOW BIRTH WEIGHT; INFANT, NEWBORN; INTERLEUKIN-10; INTERLEUKIN-6; MALE; MONOCYTES; MYCOBACTERIUM BOVIS; TIME FACTORS; TUBERCULIN TEST; TUMOR NECROSIS FACTOR-ALPHA;

EID: 84925937774     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2015.02.056     Document Type: Article

References (36)

1. World Health Organisation BCG vaccine. WHO position paper. Wkly Epidemiol Rec 2004, 4:25-40.
2. Kristensen I. Aaby P. Jensen H. Routine vaccinations and child survival: follow up study in Guinea-Bissau, West Africa. BMJ 2000, 321:1435-1438.
3. Garly M.L. Martins C.L. Bale C. Balde M.A. Hedegaard K.L. Gustafson P. et al. BCG scar and positive tuberculin reaction associated with reduced child mortality in West Africa. A non-specific beneficial effect of BCG?. Vaccine 2003, 21:2782-2790.
4. Roth A. Gustafson P. Nhaga A. Djana Q. Poulsen A. Garly M.L. et al. BCG vaccination scar associated with better childhood survival in Guinea-Bissau. Int J Epidemiol 2005, 34:540-547.
5. Roth A. Sodemann M. Jensen H. Poulsen A. Gustafson P. Weise C. et al. Tuberculin reaction, BCG scar, and lower female mortality. Epidemiology 2006, 17:562-568.
6. Roth A. Jensen H. Garly M.-L. Djana Q. Martins C.L. Sodemann M. et al. Low birth weight infants and Calmette-Guerin Bacillus vaccination at birth: community study from Guinea-Bissau. Pediatr Infect Dis J 2004, 23:544-550.
7. Aaby P. Vessari H. Nielsen J. Maleta K. Benn C.S. Jensen H. et al. Sex differential effects of routine immunizations and childhood survival in rural Malawi. Pediatr Infect Dis J 2006, 25:721-727.
8. Aaby P. Jensen H. Gomes J. Fernandes M. Lisse I.M. The introduction of diphtheria-tetanus-pertussis vaccine and child mortality in rural Guinea-Bissau: an observational study. Int J Epidemiol 2004, 33:374-380.
9. Aaby P. Roth A. Ravn H. Napirna B.M. Rodrigues A. Lisse I.M. et al. Randomized trial of BCG vaccination at birth to low-birth-weight children: beneficial nonspecific effects in the neonatal period?. J Infect Dis 2011, 204:245-252.
10. Biering-Sorensen S. Aaby P. Napirna B.M. Roth A. Ravn H. Rodrigues A. et al. Small randomized trial among low-birth-weight children receiving bacillus Calmette-Guerin vaccination at first health center contact. Pediatr Infect Dis J 2012, 31:306-308.
11. Shann F. Nonspecific effects of vaccines and the reduction of mortality in children. Clin Ther 2013, 35:109-114.
12. World Health Organization Meeting of the strategic advisory group of experts on immunization, April 2014 - conclusions and recommendations. Wkly Epidemiol Rec 2014, 89(21):221-236.
13. Kleinnijenhuis J. Quintin J. Preijers F. Joosten L.A. Ifrim D.C. Saeed S. et al. Bacille Calmette-Guerin induces NOD2-dependent nonspecific protection from reinfection via epigenetic reprogramming of monocytes. Proc Natl Acad Sci U S A 2012, 109:17537-17542.
14. Barros A.J. Hirakata V.N. Alternatives for logistic regression in cross-sectional studies: an empirical comparison of models that directly estimate the prevalence ratio. BMC Med Res Methodol 2003, 3:21.
15. Pouchot J. Grasland A. Collet C. Coste J. Esdaile J.M. Vinceneux P. Reliability of tuberculin skin test measurement. Ann Intern Med 1997, 126:210-214.
16. Soh S.B. Han P.Y. Tam K.T. Yung C.F. Liew W.K. Tan N.W. et al. nvestigations into an outbreak of suppurative lymphadenitis with BCG vaccine SSI((R)) in Singapore. Vaccine 2014, 32:5809-5815.
17. Behr M.A. BCG - different strains, different vaccines?. Lancet Infect Dis 2002, 2:86-92.
18. Anderson E.J. Webb E.L. Mawa P.A. Kizza M. Lyadda N. Nampijja M. et al. The influence of BCG vaccine strain on mycobacteria-specific and non-specific immune responses in a prospective cohort of infants in Uganda. Vaccine 2012, 30:2083-2089.
19. Ritz N. Dutta B. Donath S. Casalaz D. Connell T.G. Tebruegge M. et al. The influence of bacille Calmette-Guerin vaccine strain on the immune response against tuberculosis: a randomized trial. Am J Respir Crit Care Med 2012, 185:213-222.
20. Brosch R. Gordon S.V. Garnier T. Eiglmeier K. Frigui W. Valenti P. et al. Genome plasticity of BCG and impact on vaccine efficacy. Proc Natl Acad Sci U S A 2007, 104:5596-5601.
21. Liu J. Tran V. Leung A.S. Alexander D.C. Zhu B. BCG vaccines: their mechanisms of attenuation and impact on safety and protective efficacy. Hum Vaccine 2009, 5:70-78.
22. Bedwell J. Kairo S.K. Behr M.A. Bygraves J.A. Identification of substrains of BCG vaccine using multiplex PCR. Vaccine 2001, 19:2146-2151.
23. Ritz N. Hanekom W.A. Robins-Browne R. Britton W.J. Curtis N. Influence of BCG vaccine strain on the immune response and protection against tuberculosis. FEMS Microbiol Rev 2008, 32:821-841.
24. Favorov M. Ali M. Tursunbayeva A. Aitmagambetova I. Kilgore P. Ismailov S. et al. Comparative tuberculosis (TB) prevention effectiveness in children of Bacillus Calmette-Guerin (BCG) vaccines from different sources, Kazakhstan. PLOS ONE 2012, 7:e32567.
25. Hengster P. Schnapka J. Fille M. Menardi G. Occurrence of suppurative lymphadenitis after a change of BCG vaccine. Arch Dis Child 1992, 67:952-955.
26. Alrabiaah A.A. Alsubaie S.S. Bukhari E.I. Gad A. Alzamel F.A. Outbreak of Bacille Calmette-Guerin-related lymphadenitis in Saudi children at a university hospital after a change in the strain of vaccine. Ann Saudi Med 2012, 32:4-8.
27. Kroger L. Brander E. Korppi M. Wasz-Hockert O. Backman A. Kroger H. et al. Osteitis after newborn vaccination with three different Bacillus Calmette-Guerin vaccines: twenty-nine years of experience. Pediatr Infect Dis J 1994, 13:113-116.
28. Behr M.A. Small P.M. A historical and molecular phylogeny of BCG strains. Vaccine 1999, 17:915-922.
29. Beste D.J. Peters J. Hooper T. Avignone-Rossa C. Bushell M.E. McFadden J. Compiling a molecular inventory for Mycobacterium bovis BCG at two growth rates: evidence for growth rate-mediated regulation of ribosome biosynthesis and lipid metabolism. J Bacteriol 2005, 187:1677-1684.
30. Beste D.J. Espasa M. Bonde B. Kierzek A.M. Stewart G.R. McFadden J. The genetic requirements for fast and slow growth in mycobacteria. PLoS ONE 2009, 4:e5349.
31. Venkataswamy M.M. Goldberg M.F. Baena A. Chan J. Jacobs W.R. Porcelli S.A. In vitro culture medium influences the vaccine efficacy of Mycobacterium bovis BCG. Vaccine 2012, 30:1038-1049.
32. Kernodle D.S. Warning: differences in the copy number of duplication unit 2 (DU2) within BCG Danish 1331 may influence findings involving genetically modified BCG Danish strains. Vaccine 2012, 30:6013-6014. [author reply 6015].
33. Shibayama K. Mochida K. Yagi T. Mori S. Arakawa Y. Yamamoto S. Quantification of two variant strains contained in freeze-dried Japanese BCG vaccine preparation by real-time PCR. Biologicals 2007, 35:139-143.
34. Netea M.G. Training innate immunity: the changing concept of immunological memory in innate host defence. Eur J Clin Invest 2013, 43:881-884.
35. Benn C.S. Netea M.G. Selin L.K. Aaby P. A small jab - a big effect: nonspecific immunomodulation by vaccines. Trends Immunol 2013, 34:431-439.
36. Menzies D. What does tuberculin reactivity after bacille Calmette-Guerin vaccination tell us?. Clin Infect Dis 2000, 31(Suppl. 3):S71-S74.