E-ISSN: 2619-9467

Contents    Cover    Publication Date: 22 Jun 2022
Year 2022 - Volume 32 - Issue 2

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A Review of Current Knowledge on the Development of a Group B Streptococcus Vaccine for Pregnant Women and the Protection of Neonates: Advances in Diagnosis and Treatment

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JCOG. 2022;32(2):56-66
DOI: 10.5336/jcog.2021-87370
Article Language: EN
Copyright Ⓒ 2020 by Türkiye Klinikleri. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)
ABSTRACT
Streptococcal infection remains the leading cause of neonatal sepsis and death. Systematic use of antibiotic prophylaxis and advanced neonatal care guidelines aiming in the restriction and elimination of adverse effects on neonatal Group B Streptococcus disease neither eliminated it nor restricted it. Maternal immunisation with a Group B Streptococcus vaccine is considered the best strategy for the prevention of both early and late-onset invasive Group B Streptococcus disease. However, such an effective vaccine has yet to be fully licensed, although various attempts through the years have been made. At present, a hexavalent Ia, Ib, II, III, IV and V glyco-conjugate vaccine has completed Phase I clinical trials, showed promising results among healthy adults and was allowed to undergo Phase II trials. The early observations are promising allowing larger studies for determining the factors of optimal efficacy, such as timing of administration. The specific timing of administering a Group B Streptococcus vaccine during pregnancy has yet to be determined, although evidence show that for maximum levels of anti Group B Streptococcus antibodies to be transferred to the fetus, the best time of administration is during the second half of pregnancy or early on the third trimester. Furthermore, it remains uncertain if the vaccine should be recommended to all pregnant women, only those at higher risk or those testing positive, nor are specified the benefits of a second dose. In addition, a large Phase III clinical trial is required in order to evaluate possible adverse effects, including neuro-developmental assessments of the infants born to vaccinated mothers prior to licensing any vaccine candidate.
REFERENCES:
  1. Kara SS, Polat M, Yayla BC, Demirdag TB, Tapisiz A, Tezer H, et al. Parental vaccine knowledge and behaviours: a survey of Turkish families. East Mediterr Health J. 2018;24(5):451-8. [Crossref]  [PubMed] 
  2. Bruhn K, Tillett J. Administration of vaccinations in pregnancy and postpartum. MCN Am J Matern Child Nurs. 2009;34(2):98-105. [Crossref]  [PubMed] 
  3. World Health Organization. WHO position paper, Meningococcal A conjugate vaccine: Updated guidance, February 2015. Vaccine. 2018;36(24):3421-2. [Crossref]  [PubMed] 
  4. Healy CM, Rench MA, Montesinos DP, Ng N, Swaim LS. Knowledge and attitiudes of pregnant women and their providers towards recommendations for immunization during pregnancy. Vaccine. 2015;33(41):5445-51. [Crossref]  [PubMed] 
  5. Lin FY, Weisman LE, Azimi PH, Philips JB 3rd, Clark P, Regan J, et al. Level of maternal IgG anti-group B streptococcus type III antibody correlated with protection of neonates against early-onset disease caused by this pathogen. J Infect Dis. 2004;190(5):928-34. [Crossref]  [PubMed] 
  6. Niewiesk S. Maternal antibodies: clinical significance, mechanism of interference with immune responses, and possible vaccination strategies. Front Immunol. 2014;5:446. [Crossref]  [PubMed]  [PMC] 
  7. McQuaid F, Pask S, Locock L, Davis E, Stevens Z, Plumb J, et al. Attitudes towards antenatal vaccination, Group B streptococcus and participation in clinical trials: Insights from focus groups and interviews of parents and healthcare professionals. Vaccine. 2016;34(34):4056-61. [Crossref]  [PubMed] 
  8. Glezen WP, Alpers M. Maternal immunization. Clin Infect Dis. 1999;28(2):219-24. [Crossref]  [PubMed] 
  9. Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women--Advisory Committee on Immunization Practices (ACIP), 2012. MMWR. Morb. Mortal. Wkly. Rep. 2013;62(7):131-5. [Link] 
  10. WHO preferred product characteristics for group B streptococcus vaccines, Jan 2017 - Department of Immunization, Vaccines and biologicals, Family, Womens's and Children's Health (FWC). Geneva: World Health Organization; 2017. [Link] 
  11. Global Advisory Committee on Vaccine Safety, June 2012. Wkly Epidemiol Rec. 2012;87(30):281-7. English, French. [PubMed] 
  12. Hansen SM, Uldbjerg N, Kilian M, Sørensen UB. Dynamics of Streptococcus agalactiae colonization in women during and after pregnancy and in their infants. J Clin Microbiol. 2004;42(1):83-9. [Crossref]  [PubMed]  [PMC] 
  13. Page-Ramsey SM, Johnstone SK, Kim D, Ramsey PS. Prevalence of group B Streptococcus colonization in subsequent pregnancies of group B Streptococcus-colonized versus noncolonized women. Am J Perinatol. 2013;30(5):383-8. [Crossref]  [PubMed] 
  14. Heath PT. Status of vaccine research and development of vaccines for GBS. Vaccine. 2016;34(26):2876-9. [Crossref]  [PubMed] 
  15. Seale AC, Blencowe H, Bianchi-Jassir F, Embleton N, Bassat Q, Ordi J, et al. Stillbirth With Group B Streptococcus Disease Worldwide: Systematic Review and Meta-analyses. Clin Infect Dis. 2017;65(suppl_2):S125-S132. [PubMed]  [PMC] 
  16. Banno H, Kimura K, Tanaka Y, Sekizuka T, Kuroda M, Jin W, et al. Analysis of multidrug resistant group B streptococci with reduced penicillin susceptibility forming small, less hemolytic colonies. PLoS One. 2017;12(8):e0183453. [Crossref]  [PubMed]  [PMC] 
  17. Ellington M, Kasat K, Williams K, Reichman V, Stoffels G, Ming Leung T, et al. Improving Antibiotic Stewardship among Asymptomatic Newborns Using the Early-onset Sepsis Risk Calculator. Pediatr Qual Saf. 2021;6(5):e459. [Crossref]  [PubMed]  [PMC] 
  18. Prevention of Group B Streptococcal Early-Onset Disease in Newborns: ACOG Committee Opinion, Number 797. Obstet Gynecol. 2020;135(2):e51-e72. Erratum in: Obstet Gynecol. 2020;135(4):978-979. [Crossref]  [PubMed] 
  19. Verani JR, McGee L, Schrag SJ; Division of Bacterial Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC). Prevention of perinatal group B streptococcal disease--revised guidelines from CDC, 2010. MMWR Recomm Rep. 2010;59(RR-10):1-36. [PubMed] 
  20. Schrag SJ, Zell ER, Lynfield R, Roome A, Arnold KE, Craig AS, et al; Active Bacterial Core Surveillance Team. A population-based comparison of strategies to prevent early-onset group B streptococcal disease in neonates. N Engl J Med. 2002;347(4):233-9. [Crossref]  [PubMed] 
  21. Schuchat A. Group B streptococcus. Lancet. 1999;353(9146):51-6. [Crossref]  [PubMed] 
  22. Gaschignard J, Levy C, Romain O, Cohen R, Bingen E, Aujard Y, et al. Neonatal Bacterial Meningitis: 444 Cases in 7 Years. Pediatr Infect Dis J. 2011;30(3):212-7. [Crossref]  [PubMed] 
  23. Özen B, Van Strijp AJ, Özer L, Olmus H, Genc A, Cehreli SB. Evaluation of possible associated factors for early childhood caries and severe early childhood caries: a multicenter cross-sectional survey. J Clin Pediatr Dent. 2016;40(2):118-23. [Crossref]  [PubMed] 
  24. Stoll BJ, Hansen N, Fanaroff AA, Wright LL, Carlo WA, Ehrenkranz RA, et al. Late-onset sepsis in very low birth weight neonates: the experience of the NICHD Neonatal Research Network. Pediatrics. 2002;110(2 Pt 1):285-91. [Crossref]  [PubMed] 
  25. Lu J, Guevara MA, Francis JD, Spicer SK, Moore RE, Chambers SA, et al. Analysis of Susceptibility to the Antimicrobial and Anti-Biofilm Activity of Human Milk Lactoferrin in Clinical Strains of Streptococcus agalactiae With Diverse Capsular and Sequence Types. Front Cell Infect Microbiol. 2021;11:740872. [Crossref]  [PubMed]  [PMC] 
  26. Libster R, Edwards KM, Levent F, Edwards MS, Rench MA, Castagnini LA, et al. Long-term outcomes of group B streptococcal meningitis. Pediatrics. 2012;130(1):e8-15. [Crossref]  [PubMed] 
  27. Sewell E, Roberts J, Mukhopadhyay S. Association of Infection in Neonates and Long-Term Neurodevelopmental Outcome. Clin Perinatol. 2021;48(2):251-261. [Crossref]  [PubMed]  [PMC] 
  28. van den Berg JP, Westerbeek EA, Smits GP, van der Klis FR, Berbers GA, van Elburg RM. Lower transplacental antibody transport for measles, mumps, rubella and varicella zoster in very preterm infants. PLoS One. 2014;9(4):e94714. [Crossref]  [PubMed]  [PMC] 
  29. Castor ML, Whitney CG, Como-Sabetti K, Facklam RR, Ferrieri P, Bartkus JM, et al. Antibiotic resistance patterns in invasive group B streptococcal isolates. Infect Dis Obstet Gynecol. 2008;2008:727505. [Crossref]  [PubMed]  [PMC] 
  30. Skoff TH, Farley MM, Petit S, Craig AS, Schaffner W, Gershman K, et al. Increasing burden of invasive group B streptococcal disease in nonpregnant adults, 1990-2007. Clin Infect Dis. 2009;49(1):85-92. [Crossref]  [PubMed] 
  31. Chu HY, Englund JA. Maternal immunization. Clin Infect Dis. 2014;59(4):560-8. [Crossref]  [PubMed]  [PMC] 
  32. Baker CJ, Kasper DL. Group B streptococcal vaccines. Rev Infect Dis. 1985;7(4):458-67. [Crossref]  [PubMed] 
  33. Phares CR, Lynfield R, Farley MM, Mohle-Boetani J, Harrison LH, Petit S, et al; Active Bacterial Core surveillance/Emerging Infections Program Network. Epidemiology of invasive group B streptococcal disease in the United States, 1999-2005. JAMA. 2008;299(17):2056-65. [PubMed] 
  34. Lin SM, Zhi Y, Ahn KB, Lim S, Seo HS. Status of group B streptococcal vaccine development. Clin Exp Vaccine Res. 2018;7(1):76-81. [Crossref]  [PubMed]  [PMC] 
  35. Nuccitelli A, Rinaudo CD, Maione D. Group B Streptococcus vaccine: state of the art. Ther Adv Vaccines. 2015;3(3):76-90. [Crossref]  [PubMed]  [PMC] 
  36. Absalon J, Segall N, Block SL, Center KJ, Scully IL, Giardina PC, et al. Safety and immunogenicity of a novel hexavalent group B streptococcus conjugate vaccine in healthy, non-pregnant adults: a phase 1/2, randomised, placebo-controlled, observer-blinded, dose-escalation trial. Lancet Infect Dis. 2021;21(2):263-74. [Crossref]  [PubMed] 
  37. Baker CJ, Edwards MS. Group B streptococcal conjugate vaccines. Arch Dis Child. 2003;88(5):375-8. [Crossref]  [PubMed]  [PMC] 
  38. Avci FY, Kasper DL. How bacterial carbohydrates influence the adaptive immune system. Annu Rev Immunol. 2010;28:107-30. [Crossref]  [PubMed] 
  39. Baker CJ, Carey VJ, Rench MA, Edwards MS, Hillier SL, Kasper DL, et al. Maternal antibody at delivery protects neonates from early onset group B streptococcal disease. J Infect Dis. 2014;209(5):781-8. [Crossref]  [PubMed]  [PMC] 
  40. Eskola J, Käyhty H, Takala AK, Peltola H, Rönnberg PR, Kela E, et al. A randomized, prospective field trial of a conjugate vaccine in the protection of infants and young children against invasive Haemophilus influenzae type b disease. N Engl J Med. 1990;323(20):1381-7. [Crossref]  [PubMed] 
  41. Leroux-Roels G, Maes C, Willekens J, De Boever F, de Rooij R, Martell L, et al. A randomized, observer-blind Phase Ib study to identify formulations and vaccine schedules of a trivalent Group B Streptococcus vaccine for use in non-pregnant and pregnant women. Vaccine. 2016;34(15):1786-91. [Crossref]  [PubMed] 
  42. Kasper DL, Paoletti LC, Wessels MR, Guttormsen HK, Carey VJ, Jennings HJ, et al. Immune response to type III group B streptococcal polysaccharide-tetanus toxoid conjugate vaccine. J Clin Invest. 1996;98(10):2308-14. [Crossref]  [PubMed]  [PMC] 
  43. Avci FY, Li X, Tsuji M, Kasper DL. A mechanism for glycoconjugate vaccine activation of the adaptive immune system and its implications for vaccine design. Nat Med. 2011;17(12):1602-9. [Crossref]  [PubMed]  [PMC] 
  44. Hillier SL, Ferrieri P, Edwards MS, Ewell M, Ferris D, Fine P, et al. A Phase 2, Randomized, Control Trial of Group B Streptococcus (GBS) Type III Capsular Polysaccharide-tetanus Toxoid (GBS III-TT) Vaccine to Prevent Vaginal Colonization With GBS III. Clin Infect Dis. 2019;68(12):2079-86. [Crossref]  [PubMed]  [PMC] 
  45. Dzanibe S, Kwatra G, Adrian PV, Kimaro-Mlacha SZ, Cutland CL, Madhi SA. Association between antibodies against group B Streptococcus surface proteins and recto-vaginal colonisation during pregnancy. Sci Rep. 2017;7(1):16454. [Crossref]  [PubMed]  [PMC] 
  46. Madrid L, Seale AC, Kohli-Lynch M, Edmond KM, Lawn JE, Heath PT, et al; Infant GBS Disease Investigator Group. Infant group B streptococcal disease incidence and serotypes worldwide: systematic review and meta-analyses. Clin Infect Dis. 2017;65(suppl_2):S160-S172. [Crossref]  [PubMed]  [PMC] 
  47. Buurman ET, Timofeyeva Y, Gu J, Kim JH, Kodali S, Liu Y, et al. A novel hexavalent capsular polysaccharide conjugate vaccine (GBS6) for the prevention of neonatal group B streptococcal infections by maternal immunization. J Infect Dis. 2019;220(1):105-15. [Crossref]  [PubMed]  [PMC] 
  48. Baker CJ, Rench MA, Fernandez M, Paoletti LC, Kasper DL, Edwards MS. Safety and immunogenicity of a bivalent group B streptococcal conjugate vaccine for serotypes II and III. J Infect Dis. 2003;188(1):66-73. [Crossref]  [PubMed] 
  49. Edmond KM, Kortsalioudaki C, Scott S, Schrag SJ, Zaidi AK, Cousens S, et al. Group B streptococcal disease in infants aged younger than 3 months: systematic review and meta-analysis. Lancet. 2012;379(9815):547-56. [Crossref]  [PubMed] 
  50. Madhi SA, Koen A, Cutland CL, Jose L, Govender N, Wittke F, et al. Antibody kinetics and response to routine vaccinations in infants born to women who received an investigational trivalent group B streptococcus polysaccharide CRM197-conjugate vaccine during pregnancy. Clin Infect Dis. 2017;65(11):1897-1904. [Crossref]  [PubMed]  [PMC] 
  51. Kobayashi M, Vekemans J, Baker CJ, Ratner AJ, Le Doare K, Schrag SJ. Group B Streptococcus vaccine development: present status and future considerations, with emphasis on perspectives for low and middle income countries. F1000Res. 2016;5:2355. [Crossref]  [PubMed]  [PMC] 
  52. Donders GG, Halperin SA, Devlieger R, Baker S, Forte P, Wittke F, et al. Maternal immunization with an investigational trivalent group B streptococcal vaccine: a randomized controlled trial. Obstet Gynecol. 2016;127(2):213-21. [Crossref]  [PubMed] 
  53. Teatero S, Ferrieri P, Martin I, Demczuk W, McGeer A, Fittipaldi N. Serotype distribution, population structure, and antimicrobial resistance of group B streptococcus strains recovered from colonized pregnant women. J Clin Microbiol. 2017;55(2):412-22. [Crossref]  [PubMed]  [PMC] 
  54. Meehan M, Cunney R, Cafferkey M. Molecular epidemiology of group B streptococci in Ireland reveals a diverse population with evidence of capsular switching. Eur J Clin Microbiol Infect Dis. 2014;33(7):1155-62. [Crossref]  [PubMed] 
  55. Rappuoli R. Reverse vaccinology. Curr Opin Microbiol. 2000;3(5):445-50. [Crossref]  [PubMed] 
  56. Giuliani MM, Adu-Bobie J, Comanducci M, Aricò B, Savino S, Santini L, et al. A universal vaccine for serogroup B meningococcus. Proc Natl Acad Sci U S A. 2006;103(29):10834-9. [Crossref]  [PubMed]  [PMC] 
  57. Pizza M, Scarlato V, Masignani V, Giuliani MM, Aricò B, Comanducci M, et al. Identification of vaccine candidates against serogroup B meningococcus by whole-genome sequencing. Science. 2000;287(5459):1816-20. [Crossref]  [PubMed] 
  58. Sette A, Rappuoli R. Reverse vaccinology: developing vaccines in the era of genomics. Immunity. 2010;33(4):530-41. [Crossref]  [PubMed]  [PMC] 
  59. Maione D, Margarit I, Rinaudo CD, Masignani V, Mora M, Scarselli M, et al. Identification of a universal Group B streptococcus vaccine by multiple genome screen. Science. 2005;309(5731):148-50. Erratum in: Science. 2013;339(6116):141. Nardi Dei, Vincenzo [corrected to Nardi-Dei, Vincenzo]. [Crossref]  [PubMed]  [PMC] 
  60. Baker CJ, Rench MA, McInnes P. Immunization of pregnant women with group B streptococcal type III capsular polysaccharide-tetanus toxoid conjugate vaccine. Vaccine. 2003;21(24):3468-72. [Crossref]  [PubMed] 
  61. Edwards MS, Lane HJ, Hillier SL, Rench MA, Baker CJ. Persistence of functional antibodies to group B streptococcal capsular polysaccharides following immunization with glycoconjugate vaccines. Vaccine. 2012;30(28):4123-6. [Crossref]  [PubMed]  [PMC] 
  62. Leineweber B, Grote V, Schaad UB, Heininger U. Transplacentally acquired immunoglobulin G antibodies against measles, mumps, rubella and varicella-zoster virus in preterm and full term newborns. Pediatr Infect Dis J. 2004;23(4):361-3. [Crossref]  [PubMed] 
  63. Carreras-Abad C, Ramkhelawon L, Heath PT, Le Doare K. A Vaccine Against Group B Streptococcus: Recent Advances. Infect Drug Resist. 2020;13:1263-1272. [Crossref]  [PubMed]  [PMC] 
  64. Bianchi-Jassir F, Paul P, To KN, Carreras-Abad C, Seale AC, Jauneikaite E, et al. Systematic review of Group B Streptococcal capsular types, sequence types and surface proteins as potential vaccine candidates. Vaccine. 2020;38(43):6682-94. [Crossref]  [PubMed]  [PMC] 
  65. Leroux-Roels G, Bebia Z, Maes C, Aerssens A, De Boever F, Grassano L, et al. Safety and Immunogenicity of a Second Dose of an Investigational Maternal Trivalent Group B Streptococcus Vaccine in Nonpregnant Women 4-6 Years After a First Dose: Results From a Phase 2 Trial. Clin Infect Dis. 2020;70(12):2570-9. [Crossref]  [PubMed]  [PMC] 
  66. McQuaid F, Jones C, Stevens Z, Plumb J, Hughes R, Bedford H, et al. Factors influencing women's attitudes towards antenatal vaccines, group B Streptococcus and clinical trial participation in pregnancy: an online survey. BMJ Open. 2016;6(4):e010790. [Crossref]  [PubMed]  [PMC] 
  67. McQuaid F, Jones C, Stevens Z, Meddaugh G, O'Sullivan C, Donaldson B, et al. Antenatal vaccination against Group B streptococcus: attitudes of pregnant women and healthcare professionals in the UK towards participation in clinical trials and routine implementation. Acta Obstet Gynecol Scand. 2018;97(3):330-40. [Crossref]  [PubMed] 
  68. Alshengeti A, Alharbi A, Alraddadi S, Alawfi A, Aljohani B. Knowledge, attitude and current practices of pregnant women towards group B streptococcus screening: cross-sectional study, Al-Madinah, Saudi Arabia. BMJ Open. 2020;10(2):e032487. [Crossref]  [PubMed]  [PMC] 
  69. Michihata N, Yamamoto KH, Mukaigawara M, Miyairi I, Mori R. Group B streptococcus immunisation during pregnancy for improving outcomes. Cochrane Database Syst. Rev. 2015;2015. [Crossref] 
  70. Fortner KB, Swamy GK, Broder KR, Jimenez-Truque N, Zhu Y, Moro PL, et al. Reactogenicity and immunogenicity of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant and nonpregnant women. Vaccine. 2018;36(42):6354-60. [Crossref]  [PubMed]  [PMC] 
  71. Beran J, Leroux-Roels G, Van Damme P, de Hoon J, Vandermeulen C, Al-Ibrahim M, et al. Safety and immunogenicity of fully liquid and lyophilized formulations of an investigational trivalent group B streptococcus vaccine in healthy non-pregnant women: Results from a randomized comparative phase II trial. Vaccine. 2020;38(16):3227-34. [Crossref]  [PubMed]