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Novel Vaccines – Reviews

Advances towards licensure of a maternal vaccine for the prevention of invasive group B streptococcus disease in infants: a discussion of different approaches

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Article: 2037350 | Received 22 Oct 2021, Accepted 20 Jan 2022, Published online: 03 Mar 2022

References

  • Foxman B, Gillespie BW, Manning SD, Marrs CF. Risk factors for group B streptococcal colonization: potential for different transmission systems by capsular type. Ann Epidemiol. 2007;17(11):854–12. doi:10.1016/j.annepidem.2007.05.014.
  • Baker CJ, Barrett FF, Gordon RC, Yow MD. Suppurative meningitis due to streptococci of Lancefield group B: a study of 33 infants. J Pediatr. 1973;82(4):724–29. doi:10.1016/S0022-3476(73)80606-7.
  • Madrid L, Seale AC, Kohli-Lynch M, Edmond KM, Lawn JE, Heath PT, Madhi SA, Baker CJ, Bartlett L, Cutland C, et al. Infant Group B streptococcal disease incidence and serotypes worldwide: systematic review and meta-analyses. Clin Infect Dis. 2017;65(suppl_2):S160–S72. doi:10.1093/cid/cix656.
  • Thigpen MC, Whitney CG, Messonnier NE, Zell ER, Lynfield R, Hadler JL, Harrison LH, Farley MM, Reingold A, Bennett NM, et al. Bacterial meningitis in the United States, 1998–2007. N Engl J Med. 2011;364(21):2016–25. doi:10.1056/NEJMoa1005384.
  • Libster R, Edwards KM, Levent F, Edwards MS, Rench MA, Castagnini LA, Cooper T, Sparks RC, Baker CJ, Shah PE. Long-Term outcomes of group B streptococcal meningitis. Pediatrics. 2012;130(1):e8–e15. doi:10.1542/peds.2011-3453.
  • World Health Organization. Group B streptococcus vaccine: full value of vaccine assessment. 2 Nov 2021. https://www.who.int/publications/i/item/9789240037526 .
  • Baker CJ, Barrett FF. Transmission of group B streptococci among parturient women and their neonates. J Pediatr. 1973;83(6):919–25. doi:10.1016/S0022-3476(73)80524-4.
  • Russell NJ, Seale AC, Oʻ-Sullivan C, Le Doare K, Heath PT, Lawn JE, Bartlett L, Cutland C, Gravett M, Ip M, et al. Risk of early-onset neonatal group B streptococcal disease with maternal colonization worldwide: systematic review and meta-analyses. Clin Infect Dis. 2017;65(suppl_2):S152–S9. doi:10.1093/cid/cix655.
  • Puopolo KM, Lynfield R, Cummings JJ. Committee On Fetus Newborn, Committee On Infectious Diseases. Management of Infants at risk for group B streptococcal Disease. Pediatrics. 2019;144:e20191881.
  • Boyer KM, Gotoff SP. Strategies for chemoprophylaxis of GBS early-onset infections. Antibiot Chemother. 1985;35:267–80.
  • Baker CJ. The spectrum of perinatal group B streptococcal disease. Vaccine. 2013;Suppl 31:D3–6. doi:10.1016/j.vaccine.2013.02.030.
  • de Goffau MC, Lager S, Sovio U, Gaccioli F, Cook E, Peacock SJ, Parkhill J, Charnock-Jones DS, Smith GCS. Human placenta has no microbiome but can contain potential pathogens. Nature. 2019;572(7769):329–34. doi:10.1038/s41586-019-1451-5.
  • Lin FY, Weisman LE, Azimi P, Young AE, Chang K, Cielo M, Moyer P, Troendle JF, Schneerson R, Robbins JB. Assessment of intrapartum antibiotic prophylaxis for the prevention of early-onset group B Streptococcal disease. Pediatr Infect Dis J. 2011;30(9):759–63. doi:10.1097/INF.0b013e31821dc76f.
  • Edwards JM, Watson N, Focht C, Wynn C, Todd CA, Walter EB, Heine RP, Swamy GK. Group B Streptococcus (GBS) colonization and disease among pregnant women: a historical cohort study. Infect Dis Obstet Gynecol. 2019;2019:5430493. doi:10.1155/2019/5430493.
  • Hall J, Adams NH, Bartlett L, Seale AC, Lamagni T, Bianchi-Jassir F, Lawn JE, Baker CJ, Cutland C, Heath PT, et al. Maternal disease with group B Streptococcus and serotype distribution worldwide: systematic review and meta-analyses. Clin Infect Dis. 2017;65(suppl_2):S112–S24. doi:10.1093/cid/cix660.
  • Centers for Disease Control and Prevention. Active bacterial core surveillance report, emerging infections program network, group B Streptococcus, 2018. 19 May 2020. https://www.cdc.gov/abcs/reports-findings/survreports/gbs18.html .
  • Seale AC, Bianchi-Jassir F, Russell NJ, Kohli-Lynch M, Tann CJ, Hall J, Madrid L, Blencowe H, Cousens S, Baker CJ, et al. Estimates of the burden of group B Streptococcal disease worldwide for pregnant women, stillbirths, and children. Clin Infect Dis. 2017;65(suppl_2):S200–S19. doi:10.1093/cid/cix664.
  • Bianchi-Jassir F, Seale AC, Kohli-Lynch M, Lawn JE, Baker CJ, Bartlett L, Cutland C, Gravett MG, Heath PT, Ip M, et al. Preterm birth associated with group B Streptococcus maternal colonization worldwide: systematic review and meta-analyses. Clin Infect Dis. 2017;65(suppl_2):S133–S42. doi:10.1093/cid/cix661.
  • Boyer KM, Gotoff SP. Prevention of early-onset neonatal group B streptococcal disease with selective intrapartum chemoprophylaxis. N Engl J Med. 1986;314(26):1665–69. doi:10.1056/NEJM198606263142603.
  • Verani JR, McGee L, Schrag SJ. Prevention of perinatal group B streptococcal disease-revised guidelines from CDC. 2010. MMWR Recomm Rep. 2010;59:1–36.
  • Van Dyke MK, Phares CR, Lynfield R, Thomas AR, Arnold KE, Craig AS, Mohle-Boetani J, Gershman K, Schaffner W, Petit S, et al. Evaluation of universal antenatal screening for group B streptococcus. N Engl J Med. 2009;360(25):2626–36. doi:10.1056/NEJMoa0806820.
  • Schrag SJ, Verani JR. Intrapartum antibiotic prophylaxis for the prevention of perinatal group B streptococcal disease: experience in the United States and implications for a potential group B streptococcal vaccine. Vaccine. 2013;Suppl 31:D20–6. doi:10.1016/j.vaccine.2012.11.056.
  • Jordan HT, Farley MM, Craig A, Mohle-Boetani J, Harrison LH, Petit S, Lynfield R, Thomas A, Zansky S, Gershman K, et al. Revisiting the need for vaccine prevention of late-onset neonatal group B streptococcal disease: a multistate, population-based analysis. Pediatr Infect Dis J. 2008;27(12):1057–64. doi:10.1097/INF.0b013e318180b3b9.
  • Ledger WJ, Blaser MJ. Are we using too many antibiotics during pregnancy? BJOG. 2013;120(12):1450–52. doi:10.1111/1471-0528.12371.
  • Stoll BJ, Puopolo KM, Hansen NI, Sanchez PJ, Bell EF, Carlo WA, Cotten CM, DʻAngio CT, Kazzi SN, Poindexter BB, et al. Early-Onset neonatal sepsis 2015 to 2017, the rise of escherichia coli , and the need for novel prevention strategies. JAMA Pediatr. 2020;174(7):e200593. doi:10.1001/jamapediatrics.2020.0593.
  • Schrag S, Gorwitz R, Fultz-Butts K, Schuchat A. Prevention of perinatal group B streptococcal disease. Revised guidelines from CDC. MMWR Recomm Rep. 2002;51:1–22.
  • Hayes K, Oʻ-Halloran F, Cotter L. A review of antibiotic resistance in Group B Streptococcus: the story so far. Crit Rev Microbiol. 2020;46(3):253–69. doi:10.1080/1040841X.2020.1758626.
  • Centers for Disease Control and Prevention. Evaluation and diagnosis of penicillin allergy for healthcare professionals. 31 Oct 2017. https://www.cdc.gov/antibiotic-use/community/pdfs/penicillin-factsheet.pdf .
  • Royal College of Obstetricians & Gynecologists. Group B Streptococcal disease, Early-onset (Green-top guideline no. 36). 13 Sept 2017. https://www.rcog.org.uk/en/guidelines-research-services/guidelines/gtg36/2017 .
  • UK National Screening Committee. Group B Streptococcus. Antenatal screening programme. March 2017. https://view-health-screening-recommendations.service.gov.uk/group-b-streptococcus/2017 .
  • Dangor Z, Cutland CL, Izu A, Kwatra G, Trenor S, Lala SG, Madhi SA. Temporal changes in invasive group B Streptococcus serotypes: implications for vaccine development. PLoS One. 2016;11(12):e0169101. doi:10.1371/journal.pone.0169101.
  • Rivera L, Saez-Llorens X, Feris-Iglesias J, Ip M, Saha S, Adrian PV, Madhi SA, Boudville IC, Cunnington MC, Casellas JM, et al. Incidence and serotype distribution of invasive group B streptococcal disease in young infants: a multi-country observational study. BMC Pediatr. 2015;15(1):143. doi:10.1186/s12887-015-0460-2.
  • Pollard AJ, Perrett KP, Beverley PC. Maintaining protection against invasive bacteria with protein–polysaccharide conjugate vaccines. Nat Rev Immunol. 2009;9(3):213–20. doi:10.1038/nri2494.
  • Absalon J, Segall N, Block SL, Center KJ, Scully IL, Giardina PC, Peterson J, Watson WJ, Gruber WC, Jansen KU, 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. doi:10.1016/S1473-3099(20)30478-3.
  • Sobanjo-Ter Meulen A, Abramson J, Mason E, Rees H, Schwalbe N, Bergquist S, Klugman KP., et al. Path to impact: A report from the Bill and Melinda Gates Foundation convening on maternal immunization in resource-limited settings; Berlin – January 29–30, 2015. Vaccine. 2015;33(47):6388–95. doi:10.1016/j.vaccine.2015.08.047.
  • Palmeira P, Quinello C, Silveira-Lessa AL, Zago CA, and Carneiro-Sampaio M. IgG placental transfer in healthy and pathological pregnancies. Clin Dev Immunol. 2012;2012:985646.
  • Wilcox CR, Holder B, Jones CE. Factors affecting the FcRn-mediated transplacental transfer of antibodies and implications for vaccination in pregnancy. Front Immunol. 2017;8:1294. doi:10.3389/fimmu.2017.01294.
  • Abu Raya B, Edwards KM, Scheifele DW, Halperin SA. Pertussis and influenza immunisation during pregnancy: a landscape review. Lancet Infect Dis. 2017;17(7):e209–e22. doi:10.1016/S1473-3099(17)30190-1.
  • Centers for Disease Control and Prevention. COVID-19 vaccines while pregnant or breastfeeding. 7 Oct 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html .
  • Hillier SL, Ferrieri P, Edwards MS, Ewell M, Ferris D, Fine P, Carey V, Meyn L, Hoagland D, Kasper DL, 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. doi:10.1093/cid/ciy838.
  • Russell LB, Kim S-Y, Cosgriff B, Pentakota SR, Schrag SJ, Sobanjo-Ter Meulen A, Verani JR, Sinha A. Cost-Effectiveness of maternal GBS immunization in low-income sub-Saharan Africa. Vaccine. 2017;35(49):6905–14. doi:10.1016/j.vaccine.2017.07.108.
  • Marques MB, Kasper DL, Pangburn MK, Wessels MR. Prevention of C3 deposition by capsular polysaccharide is a virulence mechanism of type III group B streptococci. Infect Immun. 1992;60(10):3986–93. doi:10.1128/iai.60.10.3986-3993.1992.
  • Berti F, Adamo R. Recent mechanistic insights on glycoconjugate vaccines and future perspectives. ACS Chem Biol. 2013;8(8):1653–63. doi:10.1021/cb400423g.
  • Madzivhandila M, Adrian PV, Cutland CL, Kuwanda L, Schrag SJ, Madhi SA. Serotype distribution and invasive potential of group B streptococcus isolates causing disease in infants and colonizing maternal-newborn dyads. PLoS One. 2011;6(3):e17861. doi:10.1371/journal.pone.0017861.
  • Melin P, Efstratiou A. Group B streptococcal epidemiology and vaccine needs in developed countries. Vaccine. 2013;Suppl 31:D31–42. doi:10.1016/j.vaccine.2013.05.012.
  • Buurman ET, Timofeyeva Y, Gu J, Kim JH, Kodali S, Liu Y, Mininni T, Moghazeh S, Pavliakova D, Singer C, 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. doi:10.1093/infdis/jiz062.
  • Baker CJ, Kasper DL. Correlation of maternal antibody deficiency with susceptibility to neonatal group B streptococcal infection. N Engl J Med. 1976;294(14):753–56. doi:10.1056/NEJM197604012941404.
  • Baker CJ, Carey VJ, Rench MA, Edwards MS, Hillier SL, Kasper DL, Platt R. Maternal antibody at delivery protects neonates from early onset group B streptococcal disease. J Infect Dis. 2014;209(5):781–88. doi:10.1093/infdis/jit549.
  • Lin FY, Philips JB 3rd, Azimi PH, Weisman LE, Clark P, Rhoads GG, Regan J, Concepcion NF, Frasch CE, Troendle J, et al. Level of maternal antibody required to protect neonates against early-onset disease caused by group B Streptococcus type Ia: a multicenter, seroepidemiology study. J Infect Dis. 2001;184(8):1022–28. doi:10.1086/323350.
  • Boyer KM, Kendall LS, Papierniak CK, Klegerman ME, Gotoff SP. Protective levels of human immunoglobulin G antibody to group B streptococcus type Ib. Infect Immun. 1984;45(3):618–24. doi:10.1128/iai.45.3.618-624.1984.
  • Wessels MR, Paoletti LC, Guttormsen HK, Michon F, Dʻ-Ambra AJ, Kasper DL. Structural properties of group B streptococcal type III polysaccharide conjugate vaccines that influence immunogenicity and efficacy. Infect Immun. 1998;66(5):2186–92. doi:10.1128/IAI.66.5.2186-2192.1998.
  • Baker CJ, Paoletti LC, Rench MA, Guttormsen H-K, Carey VJ, Hickman ME, Kasper D. Use of capsular polysaccharide–tetanus toxoid conjugate vaccine for type II group B streptococcus in healthy women. J Infect Dis. 2000;182(4):1129–38. doi:10.1086/315839.
  • Baker CJ, Paoletti LC, Rench MA, Guttormsen HK, Edwards MS, Kasper DL. Immune response of healthy women to 2 different group B streptococcal type V capsular polysaccharide–protein conjugate vaccines. J Infect Dis. 2004;189(6):1103–12. doi:10.1086/382193.
  • Baker CJ, Paoletti LC, Wessels MR, Guttormsen H-K, Rench MA, Hickman ME, Kasper D. Safety and immunogenicity of capsular polysaccharide–tetanus toxoid conjugate vaccines for group B Streptococcal types Ia and Ib. J Infect Dis. 1999;179(1):142–50. doi:10.1086/314574.
  • 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. doi:10.1016/S0264-410X(03)00353-0.
  • Kasper DL, Paoletti LC, Wessels MR, Guttormsen HK, Carey VJ, Jennings HJ, Baker CJ. Immune response to type III group B streptococcal polysaccharide-tetanus toxoid conjugate vaccine. J Clin Invest. 1996;98:2308–14. doi:10.1172/JCI119042.
  • Donders GG, Halperin SA, Devlieger R, Baker S, Forte P, Wittke F, Slobod KS, Dull PM. Maternal immunization with an investigational trivalent group B streptococcal vaccine: a randomized controlled trial. Obstet Gynecol. 2016;127(2):213–21. doi:10.1097/AOG.0000000000001190.
  • Leroux-Roels G, Bebia Z, Maes C, Aerssens A, De Boever F, Grassano L, Buffi G, Margarit I, Karsten A, Cho S, 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):2570–79. doi:10.1093/cid/ciz737.
  • Madhi SA, Cutland CL, Jose L, Koen A, Govender N, Wittke F, Olugbosi M, Sobanjo-ter Meulen A, Baker S, Dull PM, et al. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in healthy women and their infants: a randomised phase 1b/2 trial. Lancet Infect Dis. 2016;16(8):923–34. doi:10.1016/S1473-3099(16)00152-3.
  • Madhi SA, Koen A, Cutland CL, Jose L, Govender N, Wittke F, Olugbosi M, Sobanjo-ter Meulen A, Baker S, Dull PM, 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):1897–904. doi:10.1093/cid/cix666.
  • Pannaraj PS, Edwards MS, Ewing KT, Lewis AL, Rench MA, Baker CJ. Group B streptococcal conjugate vaccines elicit functional antibodies independent of strain O-acetylation. Vaccine. 2009;27(33):4452–56. doi:10.1016/j.vaccine.2009.05.039.
  • Dangor Z, Kwatra G, Izu A, Adrian P, Cutland CL, Velaphi S, Ballot D, Reubenson G, Zell ER, Lala SG, et al. Correlates of protection of serotype-specific capsular antibody and invasive Group B Streptococcus disease in South African infants. Vaccine. 2015;33(48):6793–99. doi:10.1016/j.vaccine.2015.10.019.
  • Swamy GK, Metz TD, Edwards KM, Soper DE, Beigi RH, Campbell JD, Grassano L, Buffi G, Dreisbach A, Margarit I, et al. Safety and immunogenicity of an investigational maternal trivalent group B streptococcus vaccine in pregnant women and their infants: results from a randomized placebo-controlled phase II trial. Vaccine. 2020;38(44):6930–40. doi:10.1016/j.vaccine.2020.08.056.
  • Fabbrini M, Rigat F, Rinaudo CD, Passalaqua I, Khacheh S, Creti R, Baldassarri L, Carboni F, Anderloni G, Rosini R, et al. The protective value of maternal group B streptococcus antibodies: quantitative and functional analysis of naturally acquired responses to capsular polysaccharides and pilus proteins in European maternal sera. Clin Infect Dis. 2016;63(6):746–53. doi:10.1093/cid/ciw377.
  • Jodar L, Butler J, Carlone G, Dagan R, Goldblatt D, Kayhty H, Klugman K, Plikaytis B, Siber G, Kohberger R, et al. Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants. Vaccine. 2003;21(23):3265–72. doi:10.1016/S0264-410X(03)00230-5.
  • Lin FY, Weisman LE, Azimi PH, Philips JB 3rd, Clark P, Regan J, Rhoads GG, Frasch CE, Gray BM, Troendle 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. doi:10.1086/422756.
  • Madhi SA, Izu A, Kwatra G, Jones S, Dangor Z, Wadula J, Moultrie A, Adam Y, Pu W, Henry O, et al. Association of group B streptococcus (GBS) serum serotype-specific anticapsular immunoglobulin G concentration and risk reduction for invasive GBS disease in South African infants: an observational birth-cohort, matched case-control study. Clin Infect Dis. 2021;73(5):e1170–e80. doi:10.1093/cid/ciaa1873.
  • Carey VJ, Baker CJ, Platt R. Bayesian inference on protective antibody levels using case-control data. Biometrics. 2001;57(1):135–42. doi:10.1111/j.0006-341X.2001.00135.x.
  • Rose S, van der Laan MJ. Simple optimal weighting of cases and controls in case-control studies. Int J Biostat. 2008;4(1): Article 19. doi:10.2202/1557-4679.1115.
  • Food and Drug Administration (FDA). Center for Biologics Evaluation and Research (CBER). Approaches for demonstrating effectiveness of group B streptococcus (GBS) vaccines intended for use in pregnant women to protect the newborn infant. 152nd meeting of the vaccines and related biological products advisory committee (VRBPAC). 17 May 2018. https://www.fda.gov/media/113958/download .
  • Dangor Z, Lala SG, Cutland CL, Koen A, Jose L, Nakwa F, Ramdin T, Fredericks J, Wadula J, Madhi SA. Burden of invasive group B Streptococcus disease and early neurological sequelae in South African infants. PLoS One. 2015;10(4):e0123014. doi:10.1371/journal.pone.0123014.
  • Quan V, Verani JR, Cohen C, von Gottberg A, Meiring S, Cutland CL, Schrag SJ, Madhi SA. Invasive group B streptococcal disease in South Africa: importance of surveillance methodology. PLoS One. 2016;11(4):e0152524. doi:10.1371/journal.pone.0152524.
  • Plotkin SA. Correlates of protection induced by vaccination. Clin Vaccine Immunol. 2010;17(7):1055–65. doi:10.1128/CVI.00131-10.