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Beeslaar J, Peyrani P, Absalon J, et al. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020;9(3):625-639doi: 10.1007/s40121-020-00322-5.
Beeslaar, J., Peyrani, P., Absalon, J., Maguire, J., Eiden, J., Balmer, P., Maansson, R., & Perez, J. L. (2020). Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infectious diseases and therapy, 9(3), 625-639. https://doi.org/10.1007/s40121-020-00322-5
Beeslaar, Johannes, et al. "Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data." Infectious diseases and therapy vol. 9,3 (2020): 625-639. doi: https://doi.org/10.1007/s40121-020-00322-5
Beeslaar J, Peyrani P, Absalon J, Maguire J, Eiden J, Balmer P, Maansson R, Perez JL. Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data. Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17. PMID: 32681472; PMCID: PMC7452992.
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Infect Dis Ther. 2020 Sep;9(3):625-639. doi: 10.1007/s40121-020-00322-5. Epub 2020 Jul 17.

Sex, Age, and Race Effects on Immunogenicity of MenB-FHbp, A Bivalent Meningococcal B Vaccine: Pooled Evaluation of Clinical Trial Data.

Infectious diseases and therapy

Johannes Beeslaar, Paula Peyrani, Judith Absalon, Jason Maguire, Joseph Eiden, Paul Balmer, Roger Maansson, John L Perez

Affiliations

  1. Pfizer Vaccine Clinical Research and Development, Hurley, UK. [email protected].
  2. Pfizer Vaccine Clinical Research and Development, Collegeville, PA, USA.
  3. Pfizer Vaccine Clinical Research and Development, Pearl River, NY, USA.
  4. Pfizer Vaccine Medical Development, Scientific and Clinical Affairs, Collegeville, PA, USA.

PMID: 32681472 PMCID: PMC7452992 DOI: 10.1007/s40121-020-00322-5

Abstract

INTRODUCTION: An extensive clinical development program showed that the meningococcal serogroup B-factor H binding protein (MenB-FHbp) vaccine affords protection against MenB disease for adolescents and adults. Data were pooled from multiple studies within the program to examine whether MenB-FHbp immunogenicity was influenced by sex, age, or race.

METHODS: Immunogenicity was assessed in subjects from seven studies who received 120 µg MenB-FHbp (at 0, 2, 6 months) and had evaluated immune responses against four representative test strains via serum bactericidal assays using human complement (hSBAs). Immune responses were presented by sex (male, female), age group (10-14, 15-18, 19-25, 10-25 years), and race (white, black, Asian, other).

RESULTS: Among 8026 subjects aged 10-25 years included in this analysis, MenB-FHbp elicited robust immune responses in a high percentage of subjects regardless of demographic characteristics. Across all test strains and demographic subsets, a ≥ 4-fold rise in titer from baseline was achieved in 76.7-95.0% of subjects, with no major differences by sex, age groups assessed, or races evaluated. Corresponding percentages achieving titers ≥ the lower limit of quantification (LLOQ) against all four strains combined were 79.7-87.3% (sex), 81.6-85.5% (age), and 80.0-88.1% (race). Minor differences were observed for geometric mean titers and percentages of subjects achieving titers ≥ LLOQ against each strain based on demographics.

CONCLUSION: These data suggested no clinically meaningful differences in MenB-FHbp immunogenicity when administered as a three-dose schedule based on sex, ages assessed, or races evaluated. This analysis supports the continued recommended use of MenB-FHbp to prevent MenB disease in adolescents and young adults.

TRIAL REGISTRATION: ClinicalTrials.gov identifiers, NCT00808028, NCT01830855, NCT01323270, NCT01461993, NCT01461980, NCT01352845, and NCT01299480.

Keywords: Clinical trial; Immunogenicity; Invasive meningococcal disease; Serogroup B; Vaccines

References

  1. Martinón-Torres F. Deciphering the burden of meningococcal disease: conventional and under-recognized elements. J Adolesc Health. 2016;59:S12–20. - PubMed
  2. Centers for Disease Control and Prevention. Enhanced meningococcal disease surveillance report (2017). https://www.cdc.gov/meningococcal/downloads/NCIRD-EMS-Report-2017.pdf . - PubMed
  3. European Centre for Disease Prevention and Control. Surveillance Atlas of Infectious Diseases (2019). https://ecdc.europa.eu/en/surveillance-atlas-infectious-diseases . Accessed 3 June 2019. - PubMed
  4. Balmer P, York LJ. Optimal use of meningococcal serogroup B vaccines: moving beyond outbreak control. Ther Adv Vaccines Immunother. 2018;6:49–60. - PubMed
  5. Trumenba - PubMed
  6. Bexsero - PubMed
  7. Murphy E, Andrew L, Lee KL, et al. Sequence diversity of the factor H binding protein vaccine candidate in epidemiologically relevant strains of serogroup B Neisseria meningitidis. J Infect Dis. 2009;200:379–89. - PubMed
  8. Ostergaard L, Vesikari T, Absalon J, et al. A bivalent meningococcal B vaccine in adolescents and young adults. N Engl J Med. 2017;347:2349–62. - PubMed
  9. Perez JL, Absalon J, Beeslaar J, et al. From research to licensure and beyond: clinical development of MenB-FHbp, a broadly protective meningococcal B vaccine. Expert Rev Vaccines. 2018;17:461–77. - PubMed
  10. Lord JM. The effect of ageing of the immune system on vaccination responses. Hum Vaccines Immunother. 2013;9:1364–7. - PubMed
  11. Demirjian A, Levy O. Safety and efficacy of neonatal vaccination. Eur J Immunol. 2009;39:36–46. - PubMed
  12. van Werkhoven CH, Huijts SM, Bolkenbaas M, Grobbee DE, Bonten MJ. The impact of age on the efficacy of 13-valent pneumococcal conjugate vaccine in elderly. Clin Infect Dis. 2015;61:1835–8. - PubMed
  13. Sow PS, Watson-Jones D, Kiviat N, et al. Safety and immunogenicity of human papillomavirus-16/18 AS04-adjuvanted vaccine: a randomized trial in 10-25-year-old HIV-seronegative African girls and young women. J Infect Dis. 2013;207:1753–63. - PubMed
  14. Pedersen C, Petaja T, Strauss G, et al. Immunization of early adolescent females with human papillomavirus type 16 and 18 L1 virus-like particle vaccine containing AS04 adjuvant. J Adolesc Health. 2007;40:564–71. - PubMed
  15. Flanagan KL, Fink AL, Plebanski M, Klein SL. Sex and gender differences in the outcomes of vaccination over the life course. Annu Rev Cell Dev Biol. 2017;33:577–99. - PubMed
  16. Jorgensen TN. Sex disparities in the immune response. Cell Immunol. 2015;294:61–2. - PubMed
  17. Klein SL, Jedlicka A, Pekosz A. The Xs and Y of immune responses to viral vaccines. Lancet Infect Dis. 2010;10:338–49. - PubMed
  18. Klein SL, Marriott I, Fish EN. Sex-based differences in immune function and responses to vaccination. Trans R Soc Trop Med Hyg. 2015;109:9–15. - PubMed
  19. Fink AL, Klein SL. Sex and gender impact immune responses to vaccines among the elderly. Physiology (Bethesda). 2015;30:408–16. - PubMed
  20. Haralambieva IH, Salk HM, Lambert ND, et al. Associations between race, sex and immune response variations to rubella vaccination in two independent cohorts. Vaccine. 2014;32:1946–53. - PubMed
  21. Kurupati R, Kossenkov A, Haut L, et al. Race-related differences in antibody responses to the inactivated influenza vaccine are linked to distinct pre-vaccination gene expression profiles in blood. Oncotarget. 2016;7:62898–911. - PubMed
  22. Moberley S, Licciardi PV, Balloch A, et al. Repeat pneumococcal polysaccharide vaccine in Indigenous Australian adults is associated with decreased immune responsiveness. Vaccine. 2017;35:2908–15. - PubMed
  23. Rager-Zisman B, Bazarsky E, Skibin A, et al. Differential immune responses to primary measles-mumps-rubella vaccination in Israeli children. Clin Diagn Lab Immunol. 2004;11:913–8. - PubMed
  24. Voysey M, Barker CI, Snape MD, et al. Sex-dependent immune responses to infant vaccination: an individual participant data meta-analysis of antibody and memory B cells. Vaccine. 2016;34:1657–64. - PubMed
  25. Muse D, Christensen S, Bhuyan P, et al. A phase 2, randomized, active-controlled, observer-blinded study to assess the immunogenicity, tolerability and safety of bivalent rLP2086, a meningococcal serogroup B vaccine, coadministered with tetanus, diphtheria and acellular pertussis vaccine and serogroup A, C, Y and W-135 meningococcal conjugate vaccine in healthy US adolescents. Pediatr Infect Dis J. 2016;35:673–82. - PubMed
  26. Richmond PC, Marshall HS, Nissen MD, et al. Safety, immunogenicity, and tolerability of meningococcal serogroup B bivalent recombinant lipoprotein 2086 vaccine in healthy adolescents: a randomised, single-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2012;12:597–607. - PubMed
  27. Senders S, Bhuyan P, Jiang Q, et al. Immunogenicity, tolerability, and safety in adolescents of bivalent rLP2086, a meningococcal serogroup B vaccine, coadministered with quadrivalent human papilloma virus vaccine. Pediatr Infect Dis J. 2016;35:548–54. - PubMed
  28. Vesikari T, Ostergaard L, Diez-Domingo J, et al. Meningococcal serogroup B bivalent rLP2086 vaccine elicits broad and robust serum bactericidal responses in healthy adolescents. J Ped Infect Dis Soc. 2015;35:673–82. - PubMed
  29. Vesikari T, Wysocki J, Beeslaar J, et al. Immunogenicity, safety, and tolerability of bivalent rLP2086 meningococcal group B vaccine administered concomitantly with diphtheria, tetanus, and acellular pertussis and inactivated poliomyelitis vaccines to healthy adolescents. J Pediatr Infect Dis Soc. 2016;5:180–7. - PubMed
  30. Ostergaard L, Vesikari T, Absalon J, et al. A bivalent meningococcal B vaccine in adolescents and young adults. N Engl J Med. 2017;377:2349–62. - PubMed
  31. Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129:1307–26. - PubMed
  32. Borrow R, Balmer P, Miller E. Meningococcal surrogates of protection—serum bactericidal antibody activity. Vaccine. 2005;23:2222–7. - PubMed
  33. McNeil LK, Donald RGK, Gribenko A, et al. Predicting the susceptibility of meningococcal serogroup B isolates to bactericidal antibodies elicited by bivalent rLP2086, a novel prophylactic vaccine. MBio. 2018;9:e00036-18. - PubMed
  34. Jiang HQ, Hoiseth SK, Harris SL, et al. Broad vaccine coverage predicted for a bivalent recombinant factor H binding protein based vaccine to prevent serogroup B meningococcal disease. Vaccine. 2010;28:6086–93. - PubMed
  35. Belshe RB, Edwards KM, Vesikari T, et al. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med. 2007;356:685–96. - PubMed
  36. Monto AS, Ohmit SE, Petrie JG, et al. Comparative efficacy of inactivated and live attenuated influenza vaccines. N Engl J Med. 2009;361:1260–7. - PubMed
  37. Yang Y, Meng Y, Halloran ME, Longini IM Jr. Dependency of vaccine efficacy on preexposure and age: a closer look at a tetravalent dengue vaccine. Clin Infect Dis. 2018;66:178–84. - PubMed
  38. Liko J, Robison SG, Cieslak PR. Pertussis vaccine performance in an epidemic year—Oregon, 2012. Clin Infect Dis. 2014;59:261–3. - PubMed
  39. de Moraes JC, Perkins BA, Camargo MC, et al. Protective efficacy of a serogroup B meningococcal vaccine in Sao Paulo, Brazil. Lancet. 1992;340:1074–8. - PubMed
  40. Harder T, Koch J, Wichmann O, Hellenbrand W. Predicted vs observed effectiveness of outer membrane vesicle (OMV) vaccines against meningococcal serogroup B disease: systematic review. J Infect. 2017;75:81–94. - PubMed
  41. Engler RJ, Nelson MR, Klote MM, et al. Half- vs full-dose trivalent inactivated influenza vaccine (2004–2005): age, dose, and sex effects on immune responses. Arch Intern Med. 2008;168:2405–14. - PubMed
  42. Bermal N, Szenborn L, Chrobot A, et al. The 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) coadministered with DTPw-HBV/Hib and poliovirus vaccines: assessment of immunogenicity. Pediatr Infect Dis J. 2009;28:S89–96. - PubMed
  43. Knuf M, Szenborn L, Moro M, et al. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009;28:S97–108. - PubMed
  44. Mariani L, Venuti A. HPV vaccine: an overview of immune response, clinical protection, and new approaches for the future. J Transl Med. 2010;8:105. - PubMed
  45. Vidal AC, Smith JS, Valea F, et al. HPV genotypes and cervical intraepithelial neoplasia in a multiethnic cohort in the southeastern USA. Cancer Causes Control. 2014;25:1055–62. - PubMed

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