Breadth of immune response against serogroup B1

Not actual patients.

PENMENVY demonstrated breadth of immune response against a panel of 110 diverse N. meningitidis serogroup B strains1,a representing ~95% of the serogroup B isolates circulating in the US from 2000 to 2017.1,2

 

aThis panel includes most antigen types found among serogroup B isolates circulating in the US between 2000 and 2017, and includes some strains with genetic profiles characterized as hypervirulent.1

 

Vaccination may not protect all recipients.

PENMENVY demonstrated noninferiority to BEXSERO (Meningococcal Group B Vaccine) against diverse MenB strains1,a,b,c

Noninferiority of 2 doses of PENMENVY compared with 2 doses of BEXSERO
Serum activity bar chart

The noninferiority of 2 doses of PENMENVY (0-, 6-month schedule) compared to 2 doses of BEXSERO (0-, 6-month schedule) was demonstrated based on the difference in percentages of samples with bactericidal serum activity.1

 

In the same study, the percentage of tests with bactericidal activity against meningococcal serogroup B strains for participants who received 3 doses of BEXSERO (0-,2-,6-month schedule) was 86.7% (22,184/25,596 tests). Criterion for noninferiority of PENMENVY to more than 1 comparator with respect to percent of tests with bactericidal activity was not prespecified.

  • a

    Each test qualitatively assessed (yes/no) the bactericidal activity of 1 participant’s serum using the enc-hSBA assay against 1 of the 110 US meningococcal serogroup B strains. Each participant’s serum was tested against a maximum of 35 strains randomly selected from the 110-strain panel.

  • b

    Per Protocol Set includes all participants in the Full Analysis Set minus participants with protocol deviations that led to exclusion from the Per Protocol Set.

  • c

    enc-hSBA responses were measured 1 month after Dose 2 of PENMENVY and 1 month after Dose 2 of BEXSERO (0-, 6-month schedule).

  • d

    Predefined noninferiority criterion was defined as lower limit of the 2-sided 95% CI for vaccine group differences [PENMENVY minus BEXSERO (0-, 6-month schedule)] above -5%.

  • e

    Met predefined noninferiority criterion. CI calculated using Miettinen and Nurminen method.

Responder-based immune response against serogroup B1,a,b,c,d

In a Clinical Trial:
Responder-based circle chart

In the same study, enc-hSBA response was measured 1 month after Dose 2 of BEXSERO (0-, 6-month schedule), and 89.8% of these participants were responders.a,b,d

  • a

    Each participant’s serum was tested using the enc-hSBA assay for bactericidal activity (yes/no) against a maximum of 35 strains randomly selected from the 110-strain panel.

  • b

    Full Analysis Set includes all participants who received at least 1 dose of the study treatment and have postvaccination immunogenicity data.

  • c

    enc-hSBA response was measured 1 month after Dose 2 of PENMENVY.

  • d

    % Responders is defined as percentages of participants whose serum kills ≥70% of strains tested using the enc-hSBA assay.

  • e

    Predefined criterion (lower limit of the 2-sided 95% CI >65%) met. CI calculated using Clopper-Pearson method.

Immune response against 4 serogroup B indicator strains1,a

Noninferiority of PENMENVY compared to BEXSERO (0-, 6-month schedule) for the proportion of participants with a seroresponse was demonstrated for meningococcal serogroup B indicator strains for fHbp and NadA,f but not for indicator strains for NHBA or OMV.g
MenB seroresponse bar chart
  • a

    hSBA responses were measured 1 month after Dose 2 of PENMENVY or 1 month after Dose 2 of BEXSERO (0-, 6-month schedule).

  • b

    Per Protocol Set includes all participants in the Full Analysis Set minus participants with protocol deviations that led to exclusion from the Per Protocol Set.

  • c

    Seroresponse is defined as: a postvaccination hSBA titer at least 4-fold the LOD or ≥LLOQ, whichever is greater, for participants with prevaccination hSBA titer <LOD, a postvaccination hSBA titer at least 4-fold the LLOQ for participants with prevaccination hSBA titer ≥LOD and <LLOQ, and a postvaccination hSBA titer at least 4-fold the prevaccination hSBA titer for participants with prevaccination hSBA titer ≥LLOQ.

  • d

    LOD=4 for fHbp; 6 for NadA; 4 for NHBA; 4 for OMV. LLOQ=5 for fHbp; 14 for NadA; 6 for NHBA; 6 for OMV.

  • e

    CI calculated using Clopper-Pearson method.

  • f

    Met predefined noninferiority criterion (lower limit of the 2-sided 95% CI above -10% for vaccine group differences [PENMENVY minus BEXSERO (0-, 6-month schedule)]). CI calculated using Miettinen and Nurminen method.

  • g

    Did not meet predefined noninferiority criterion (lower limit of the 2-sided 95% CI below -10% for vaccine group differences [PENMENVY minus BEXSERO (0-, 6-month schedule)]). CI calculated using Miettinen and Nurminen method.

  • h

    Full Analysis Set includes all participants who received at least 1 dose of the study treatment and have postvaccination immunogenicity data.

  • i

    Composite Response is defined as hSBA ≥LLOQ for all 4 meningococcal B indicator strains.

  • j

    Criterion for noninferiority of PENMENVY to BEXSERO (0-, 6-month schedule) with respect to the composite response was not prespecified.

4 MenB antigenic components of PENMENVY

PENMENVY contains 4 different antigenic components—fHbp, NadA, NHBA, and OMV—which target different mechanisms involved in MenB survival and disease development.1,3-5
Infographic describing the roles of MenB antigenic components

Another MenABCWY vaccine contains 2 variants of a single component, fHbp.13 There are no head-to-head clinical studies comparing PENMENVY to any other MenABCWY vaccine.

Bar graph icon

See MenACWY Immune Response

SEE THE DATA

CI=confidence interval; enc-hSBA=endogenous complement hSBA; fHbp=factor H binding protein; hSBA=human serum bactericidal activity; LLOQ=lower limit of quantitation; LOD=limit of detection; MenABCWY=meningococcal serogroups A, B, C, W, Y; MenACWY=meningococcal serogroups A, C, W, Y; MenB=meningococcal serogroup B; NadA=Neisseria adhesin A; NHBA=Neisserial Heparin Binding Antigen; OMV=Outer Membrane Vesicles.

Indication & Important Safety Info

Indications for PENMENVY, BEXSERO, and MENVEO

Important Safety Information for PENMENVY, BEXSERO, and MENVEO

Indications for PENMENVY, BEXSERO, and MENVEO

PENMENVY is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age.

 

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 aged 10 through 25 years.

 

MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections.

Important Safety Information for PENMENVY, BEXSERO, and MENVEO

  • Do not administer PENMENVY to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of PENMENVY, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine
  • Do not administer BEXSERO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of BEXSERO or after a previous dose of BEXSERO
  • Do not administer MENVEO to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of MENVEO, to any component of MENVEO, or to any other diphtheria toxoid-containing vaccine
  • Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of PENMENVY, BEXSERO, or MENVEO
  • For BEXSERO, the tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions. Please check the carton
  • Syncope (fainting) has occurred in association with administration of PENMENVY, BEXSERO, or MENVEO. Ensure procedures are in place to avoid injury from falling associated with syncope
  • PENMENVY, BEXSERO, or MENVEO may not protect all vaccine recipients, and PENMENVY or BEXSERO may not protect against all meningococcal serogroup B strains
  • Immunocompromised persons and some individuals receiving immunosuppressant therapy may have reduced immune responses to PENMENVY, BEXSERO, or MENVEO
  • Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N. meningitidis serogroups A, B, C, W, and Y, even if they develop antibodies following vaccination with PENMENVY, BEXSERO, or MENVEO
  • Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to administer PENMENVY or MENVEO to individuals with a history of GBS should take into account the expected benefits and potential risks
  • Apnea following intramuscular vaccination has been observed in some infants born prematurely. A decision about when to administer MENVEO to an infant born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination
  • For PENMENVY, the most commonly reported (≥10%) solicited adverse reactions in individuals aged 10 through 25 years after Dose 1 and Dose 2, respectively, were pain at the injection site (92% and 88%), fatigue (51% and 42%), headache (42% and 36%), myalgia (15% and 12%), nausea (15% and 10%), erythema (13% and 12%), and swelling (13% and 12%). The most commonly reported (≥10%) solicited adverse reactions in MenACWY conjugate vaccine-experienced individuals aged 15 through 25 years after Dose 1 and Dose 2, respectively, were pain at the injection site (80% and 74%), headache (41% and 33%), fatigue (40% and 33%), myalgia (15% and 13%), and nausea (15% and 12%)
  • For BEXSERO, the most commonly reported (≥10%) solicited adverse reactions in a Phase 3 clinical trial were pain at the injection site (87%-92%), fatigue (45%-49%), headache (37%-41%), nausea (11%-13%), erythema (10%-15%), myalgia (10%-14%), and swelling (10%-14%)
  • Common solicited adverse reactions with MENVEO among children initiating vaccination: at 2 months of age and receiving the four-dose series were tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea; at 7 months through 23 months of age and receiving the two-dose series were tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea; at 2 through 10 years of age who received MENVEO were injection site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Common solicited adverse reactions among adolescents and adults aged 11 through 55 years who received a single dose of MENVEO were pain at the injection site, headache, myalgia, malaise, and nausea. Across all age groups, some events were severe. Similar rates of solicited adverse reactions among adolescents and adults were observed following a single booster dose
  • For MENVEO, in two clinical studies, there were no notable differences in frequency and severity of solicited adverse reactions in individuals who received MENVEO 1-vial presentation compared to individuals who received the 2-vial presentation

 

Prescribing Information for PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine)

 

Prescribing Information for BEXSERO (Meningococcal Group B Vaccine)

 

Prescribing Information for MENVEO [Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine]

To report SUSPECTED ADVERSE REACTIONS, contact GSK at gsk.public.reportum.com or
1-888-825-5249, or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

References

  1. Prescribing Information for PENMENVY.

  2. Nolan T, Bhusal C, Beran J, et al; the QUINTET study group. Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial. Lancet Infect Dis. 2024;S1473-3099(24)00667-4. doi:10.1016/S1473-3099(24)00667-4

  3. 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. doi:10.1517/14712598.2011.585965

  4. Ellis TN, Kuehn MJ. Virulence and immunomodulatory roles of bacterial outer membrane vesicles. Microbiol Mol Biol Rev. 2010;74(1):81-94. doi:10.1128/MMBR.00031-09

  5. Prescribing Information for BEXSERO.

  6. Madico G, Welsch JA, Lewis LA, et al. The meningococcal vaccine candidate GNA1870 binds the complement regulatory protein factor H and enhances serum resistance. J Immunol. 2006;177(1):501-510. doi:10.4049/jimmunol.177.1.501

  7. Schneider MC, Prosser BE, Caesar JJ, et al. Neisseria meningitidis recruits factor H using protein mimicry of host carbohydrates. Nature. 2009;458(7240):890-893. doi:10.1038/nature07769

  8. Capecchi B, Adu-Bobie J, Di Marcello F, et al. Neisseria meningitidis NadA is a new invasin which promotes bacterial adhesion to and penetration into human epithelial cells. Mol Microbiol. 2005;55(3):687-698. doi:10.1111/j.1365-2958.2004.04423.x

  9. Comanducci M, Bambini S, Brunelli B, et al. NadA, a novel vaccine candidate of Neisseria meningitidis. J Exp Med. 2002;195(11):1445-1454. doi:10.1084/jem.20020407

  10. Mazzon C, Baldani-Guerra B, Cecchini P, et al. IFN-gamma and R-848 dependent activation of human monocyte-derived dendritic cells by Neisseria meningitidis adhesin A. J Immunol. 2007;179(6):3904-3916. doi:10.4049/jimmunol.179.6.3904

  11. Serruto D, Spadafina T, Ciucchi L, et al. Neisseria meningitidis GNA2132, a heparin-binding protein that induces protective immunity in humans. Proc Natl Acad Sci U S A. 2010;107(8):3770-3775. doi:10.1073/pnas.0915162107

  12. Martin DR, Ruijne N, McCallum L, O'Hallahan J, Oster P. The VR2 epitope on the PorA P1.7-2,4 protein is the major target for the immune response elicited by the strain-specific group B meningococcal vaccine MeNZB. Clin Vaccine Immunol. 2006;13(4):486-491. doi:10.1128/CVI.13.4.486-491.2006

  13. Prescribing Information for Penbraya.