Leaving GSK Pro

You are leaving GSK Pro to visit a separate website not associated with GSK Pro, a portal for US Healthcare Professionals.There are website links to third-party sites on GSK Pro. GSK is not responsible for content on third-party websites.

Continue

Cancel

FORMULATION AND IMMUNE RESPONSE

BEXSERO FORMULATION

>99% of invasive MenB strains contain genes for at least 1 BEXSERO component3,*

BEXSERO is the only MenB vaccine that combines 4 different antigenic components—fHbp, NadA, NHBA, and PorA P1.4—each of which targets a different mechanism related to MenB survival and disease development.4,5,*

fHbp=factor H binding protein; NadA=Neisserial adhesin A; NHBA=Neisserial Heparin Binding Antigen; PorA=Porin A P1.4 present in Outer Membrane Vesicles (OMV)

MenB strains can express varying amounts of surface protein.6,7


The majority of invasive MenB strains contain genes for more than 1 BEXSERO component, potentially providing multiple targets for vaccine-induced antibodies.3,7

BEXSERO, with 4 distinct antigenic components, offers the potential to protect against invasive MenB strains, even when the expression of 1 component is low or antigenically different.6,7

Vaccination with BEXSERO may not provide protection against all meningococcal serogroup B strains.

Indication

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.

BEXSERO IMMUNE RESPONSE

BEXSERO demonstrated serum bactericidal activity against each of three strains selected to measure responses to three respective vaccine antigens prevalent among strains in the US1,*

≥4-fold hSBA response rates 1 month post-dose 21,
  Canada/Australia Study
(11 through 17 years of age)
United Kingdom Study§
(18 through 24 years of age)
Strain (antigen) % (95% CI; N=298-299)†,∥ % (95% CI; N=147-148)†,¶
H44/76 (fHbp) 98 (95, 99) 78 (71, 85)
5/99 (NadA) 99 (98, 100) 94 (89, 97)
NZ98/254 (PorA P1.4) 39 (33, 44) 67 (58, 74)
A suitable strain for assessing bactericidal activity of NHBA-specific antibodies was not available.1
Composite hSBA response rates1,#
  Canada/Australia Study
(11 through 17 years of age)
United Kingdom Study§
(18 through 24 years of age)
  % (95% CI; N=298-299) % (95% CI; N=136-186)
Baseline 0
24 (18, 30)
1 month post-dose 2 63 (57, 68) 88 (82, 93)
11 months post-dose 2 --
66 (58, 72)
CI=Confidence interval; hSBA=human serum bactericidal assay; LLOQ=lower limit of quantification.
* Immune response data were recorded for antigens fHbp, NadA, and PorA P1.4. However, a suitable strain for assessing immune response was not available for component NHBA.1
≥4-fold hSBA response is defined as a postvaccination hSBA ≥1:16 for participants with prevaccination hSBA <1:4; a postvaccination titer at least 4-fold the LLOQ for participants with prevaccination hSBA ≥1:4 but <LLOQ, and a postvaccination 4-fold rise for participants with prevaccination hSBA ≥LLOQ.1
The Canada/Australia study was an uncontrolled study. Adolescents 11 through 17 years of age received 2 doses of BEXSERO 1 month apart (N=338).1
§ The United Kingdom study was a randomized, controlled study. University students 18 through 24 years of age received either 2 doses of BEXSERO 1 month apart (N=932) or 1 dose of MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) followed by 1 dose of placebo containing aluminum hydroxide (N=956) or 2 doses of IXIARO (Japanese Encephalitis Vaccine, Inactivated, Adsorbed) (N=947).1
LLOQ=1:16 for fHbp; 1:16 for NadA; 1:8 for PorA P1.4.1
LLOQ=1:16 for fHbp; 1:8 for NadA; 1:16 for PorA P1.4.1
# Composite hSBA response is defined as hSBA ≥LLOQ for all 3 indicator MenB strains.1

References

  1. Prescribing Information for BEXSERO.
  2. Prescribing Information for TRUMENBA.
  3. Wang X, Cohn A, Comanducci M, et al. Prevalence and genetic diversity of candidate vaccine antigens among invasive Neisseria meningitidis isolates in the United States. Vaccine. 2011;29(29-30):4739-4744.
  4. Bai X, Findlow J, Borrow R. Recombinant protein meningococcal serogroup B vaccine combined with outer membrane vesicles. Expert Opin Biol Ther. 2011;11(7):969-985.
  5. Ellis TN, Kuehn MJ. Virulence and immunomodulatory roles of bacterial outer membrane vesicles. Microbiol Mol Biol Rev. 2010;74(1):81-94.
  6. Biagini M, Spinsanti M, De Angelis G, et al. Expression of factor H binding protein in meningococcal strains can vary at least 15-fold and is genetically determined. Proc Natl Acad Sci USA. 2016;113(10):2714-2719.
  7. Vogel U, Taha M-K, Vazquez JA, et al. Predicted strain coverage of a meningococcal multicomponent vaccine (4CMenB) in Europe: a qualitative and quantitative assessment. Lancet Infect Dis. 2013;13(5):416-425.
  8. Data on file, GSK.
  9. Pelton SI. Meningococcal disease awareness: clinical and epidemiological factors affecting prevention and management in adolescents. J Adolesc Health. 2010;46:S9-S15.
  10. MacNeil J, Cohn A. Meningococcal disease. In: Roush SW, Baldy LM, eds. Manual for the Surveillance of Vaccine-Preventable Diseases. 5th ed. Atlanta, GA: Centers for Disease Control and Prevention; 2011. www.cdc.gov/vaccines/pubs/surv-manual/chpt08-mening.pdf. Accessed February 18, 2019.
  11. Meningococcal vaccination: what everyone should know. Centers for Disease Control and Prevention website: https://www.cdc.gov/vaccines/vpd/mening/hcp/adolescent-vaccine.html. Last Update May 19, 2017. Accessed April 25, 2019.
  12. Meningococcal disease. In: Hamborsky J, Kroger A, Wolfe C, eds. Epidemiology and Prevention of Vaccine-Preventable Diseases. 13th ed. Washington, DC: Public Health Foundation; 2015:231-245. www.cdc.gov/vaccines/pubs/pinkbook/mening.html. Accessed February 18, 2019.
  13. Slack R, Hawkins KC, Gilhooley L, Addison GM, Lewis MA, Webb NJA. Long-term outcome of meningococcal sepsis-associated acute renal failure. Pediatr Crit Care Med. 2005;6(4):477-479.
  14. Vyse A, Anonychuk A, Jäkel A, Wieffer H, Nadel S. The burden and impact of severe and long-term sequelae of meningococcal disease. Expert Rev Anti Infect Ther. 2013;11(6):597-604.
  15. Centers for Disease Control and Prevention website. Enhanced Meningococcal Disease Surveillance Reports, 2015-2017. www.cdc.gov/meningococcal/surveillance/index.html#enhanced-reports. Updated March 28, 2017. Accessed April 1, 2019.
  16. MacNeil JR, Rubin L, Folaranmi T, Ortega-Sanchez IR, Patel M, Martin SW. Use of serogroup B meningococcal vaccines in adolescents and young adults: recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR. 2015;64(41):1171-1176.

Indication

BEXSERO is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.

Approval of BEXSERO is based on demonstration of immune response, as measured by serum bactericidal activity against three serogroup B strains representative of prevalent strains in the United States. The effectiveness of BEXSERO against diverse serogroup B strains has not been confirmed.

Important Safety Information

  • BEXSERO is contraindicated in cases of hypersensitivity, including severe allergic reaction, to any component of the vaccine, or after a previous dose of BEXSERO
  • Appropriate observation and medical treatment should always be readily available in case of an anaphylactic event following the administration of the vaccine
  • The tip caps of the prefilled syringes contain natural rubber latex, which may cause allergic reactions in latex-sensitive individuals
  • Syncope (fainting) can occur in association with administration of BEXSERO. Ensure procedures are in place to avoid injury from falling associated with syncope
  • The most common solicited adverse reactions observed in clinical trials were pain at the injection site (≥83%), myalgia (≥48%), erythema (≥45%), fatigue (≥35%), headache (≥33%), induration (≥28%), nausea (≥18%), and arthralgia (≥13%)
  • Vaccination with BEXSERO may not provide protection against all meningococcal serogroup B strains
  • Some individuals with altered immunocompetence may have reduced immune responses to BEXSERO
  • Vaccination with BEXSERO may not result in protection in all vaccine recipients

Please see full Prescribing Information for BEXSERO.

All trademarks are the property of their respective owners.