Document text
MenABCWY for the prevention of
Invasive Meningococcal Disease
caused by serogroups A, B, C, W and Y
Wendy Sohn, MD
Global Medical Lead Neisseria Vaccines
2
Presentation by GSK at ACIP, June 2024
Concerted Prevention of IMD in Adolescents and Young Adults
Improve vaccination
coverage rates5 to meet the
greatest medical needReduce overall burden
of pain and discomfort6
Improved convenience and
compliance6Potentially better overall
economic value6Need for
pentavalent
vaccines
1.Mbaeyi S, et al. JAMA Pediatr 2020; 174 (9):843- 851; 2. Enhanced Meningococcal Disease Surveillance Reports 2015- 2022; 3. CDC Immunization Schedule 2024; 4. Pingali C, et al. MMWR Morb Mortal Wkly Rep 2023; 72(34):912- 919; 5. Marshall G, et al . Clin Infect Dis 2022,
75(1):155- 158; 6. Kroger A, et al. General Best Practice Guidelines for Immunization. [www.cdc.gov/vaccines/hcp/acip -recs/general -recs/downloads/general -recs.pdf]. Accessed on February 28th, 2024.IMD is an uncommon but
potentially devastating
disease1Out of 5 serogroups : B (75%),
CWY(25%) in 16 -23-year-olds2Recommendations based on
age and high- risk conditions3
Low vaccination coverage
for those at high- risk and
persistent disparities4,5
3
Presentation by GSK at ACIP, June 2024Immunogenicity in high- risk
patients7,8Immunogenicity and Safety in
Healthy 2 months -55 year -olds2 MenABCWY Program Built on Antigenic Components of
MenACWYCRM (Menveo) and MenB -4C (Bexsero)
Real- world effectiveness13Persistence of immune response
after 4 -7.5 years12Immunogenicity and Safety in
Healthy 10- 25 year -olds3
Real- world effectiveness14-16Immunogenicity in high- risk
patients4-6
Persistence of immune response
after 4 -6 years9-11Immunogenicity and Safety in
Healthy 10-25 year -oldsMenACWYCRM2MenB -4C3
2010 2015 Anticipated 20251MenABCWY1=Lyophilized MenACWYCRM
(vial)+
1. GSK Press Release April 16, 2024. https://www.gsk.com/en -gb/media/press -releases/gsk -s-5-in-1-meningococcal -abcwy -vaccine -candidate- accepted -for-regulatory -review -by-us-fda/; 2. Prescribing Information for MENVEO ; 3. Prescribing Information for BEXSERO ; 4. Isitt C et al, HIV
Med. 2023; 24(9):979- 989; 5 . Kimura A et al, Clinical and Vaccine Immunology . 2011; 18(3):483- 486; 6. Findlow J et al, Vaccine. 2015; 33(29):3322- 30; 7.Martinon -Torres F et al, P ediatrics . 2018; 142(3): e207174250; 8. Robin C et al , Clin Microbiol Infect. 2022, 28(12):1609- 1614; 9.
Tipton et al, Vaccine. 2019; 37(42):6171- 6179; 10. Baxter et al, Pediatr Infect Dis J. 2014; 33(11):1169 -1176; 11. Jacobson et al Pediatr Infect Dis J. 2013; 32(4):e170- 177; 12. Watson PS et al. Expert Review of Vaccines. 2019; 18:4, 343- 352; 13. Hyoung Im J et al, Vaccine. 2020; 38
(730- 732); 14. McMillan M et al, Clin Infect Dis. 2021; 73(1):e233– 7; 15. Wang B et al Lancet Infect Dis. 2022; 22:1011– 20; 16. Wang B et al. J Infect. 2023; 22:S0163– 4453Liquid MenB -4C
(prefilled syringe)
4
Presentation by GSK at ACIP, June 20241. GSK Press Release April 16, 2024. https://www.gsk.com/en -gb/media/press -releases/gsk -s-5-in-1-meningococcal -abcwy -vaccine- candidate- accepted- for-regulatory -review -by-us-fda/;
2. MenABCWY Candidate Vaccine Draft Prescribing Information, February 2024
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
Administer 2 doses (0.5 mL each) intramuscularly at least 6 months apart MenABCWY Proposed Indication2MenABCWY Program Built on Antigenic Components of
MenACWYCRM (Menveo) and MenB -4C (Bexsero)
MenABCWY1=Lyophilized MenACWYCRM
(vial)+Liquid MenB -4C
(prefilled syringe)
5
Presentation by GSK at ACIP, June 2024
Vaccine exposed set1N
MenABCWY (Total) 3,718
MenABCWY 1,216
MenB -4C 2,969
MenACWYCRM 361
TOTAL
receiving ≥ 1 dose of study vaccine7,048Comprehensive MenABCWY Clinical Development Program
12 Studies, >7,000 Participants, 13 Countries
10 completed Ph1-2 studies: different formulations and administration schedules in ages 9 – 42 years1
2 completed Ph3 studies: safety and immunogenicity of MenABCWY in MenACWY -naïve and primed 10-
25 yrs2-3
1 ongoing Phase 2 study: evaluating 2 doses administered 2 or 4 years apart in ages 11 – 14 years4
North America
N=2,770
South America
N=447
Australia
N=532
Europe
N=3,299
1. GSK, Data on File 2024N555071; 2. Clinicaltrials.gov identifier NCT04502693 , accessed May 31st, 2024; 3. Clinicaltrials.gov identifier NCT04707391 , accessed May 31st, 2024; 4. Clinicaltrials.gov identifier NCT05087056 , accessed May 31st, 2024.
6
Presentation by GSK at ACIP, June 2024
10-25 years of age
MenACWY -naïve
15-25 years of age
MenACWY -primed*
MenABCWY -019Phase 3 Studies Assessed Safety and Immunogenicity of MenABCWY
MenB-4C 0,2,6
N=897
MenB-4C 0,6
N=906
MenACWYCRM
N=178
MenABCWY 0,6
N=1,657
N=1,247
MenACWYCRM +
MenB N=621
MenABCWY 0,6
N=626
Month 0 1 2 3 6 7 12
V72_72
N for each study arm depicts the exposed set. *MenACWY -primed participants received dose of licensed MenACWY vaccine ≥ 4 years prior to study start
Clinicaltrials.gov identifier NCT04502693 , accessed May 31st, 2024 and Clinicaltrials.gov identifier NCT04707391 , accessed May 31st, 2024.Compared to MenB- 4C, MenACWYCRM Administered per CDC Schedule at Study Onset
Study populations
Healthy participants,
without progressive,
unstable or
uncontrolled clinical
conditions (including
abnormal immune
function)
MenB -naïveN=3,638
Placebo MenABCWY MenB -4C MenACWYCRM
7
Presentation by GSK at ACIP, June 2024Demographics and Baseline Characteristics of Phase 3 Studies
V72_72 MenABCWY -019
MenABCWY
N=1,657MenB -4C 0- 6
N=906MenACWYCRM
N=178MenABCWY
N=626MenACWYCRM
N=621
Median age At 1st vaccination, years (range) 16 (9 –26) 16 (9 –26) 16 (10 –25) 16 (15 –25) 16 (15 –25)
Age group10–11 years 320 (19%) 172 (19%) 27 (15%) 0 0
12–17 years 666 (40%) 368 (41%) 76 (43%) 450 (72%) 441 (71%)
18–25 years 671 (40%) 366 (40%) 75 (42%) 176 (28%) 180 (29%)
Region US 491 (30%) 270 (30%) 52 (29%) 366 (59%) 365 (59%)
Sex Female 933 (56%) 446 (49%) 100 (56%) 343 (55%) 325 (52%)
RaceWhite 1492 (90%) 791 (87%) 162 (91%) 474 (76%) 467 (75%)
Asian 71 (4%) 60 (7%) 9 (5%) 22 (4%) 33 (5%)
Black or African American 59 (4%) 29 (3%) 6 (3%) 94 (15%) 86 (14%)
Other 35 (2%) 26 (3%) 1 (1%) 36 (6%) 38 (6%)
EthnicityNot Hispanic or Latino 1546 (93%) 852 (94%) 172 (97%) 447 (71%) 432 (69%)
Hispanic or Latino 92 (6%) 41 (5%) 6 (3%) 179 (29%) 192 (31%)
Not reported 19 (1%) 13 (1%) 0 0 0
N for each study arm depicts the exposed set.
Clinicaltrials.gov identifier NCT04502693 , accessed May 31st, 2024 and Clinicaltrials.gov identifier NCT04707391 , accessed May 31st, 2024.
8
Presentation by GSK at ACIP, June 2024Immunogenicity of MenABCWY against
110 serogroup B strains
GSK’s
MenABCWYSerogroup B Serogroups A C W Y
Immunological noninferiority
ofMenABCWY vs MenB -4C
Persistence and booster immune
response up to 24 months
Evidence Supporting Safety and Immunogenicity of MenABCWY
Solicited and unsolicited adverse events after each dose of MenABCWY, MenB -4C or MenACWYCRM
Non- inferiority vs MenACWYCRM
in MenACWY -naïve and -primed
Clinicaltrials.gov identifier NCT04502693 , accessed May 31st, 2024; Clinicaltrials.gov identifier NCT04707391 , accessed May 31st, 2024; Vesikari T et al. Hum Vaccin Immunother 2021;17(11):4689- 4700
9
Presentation by GSK at ACIP, June 20240%20%40%60%80%100%
†Severity of symptom‡Size (mm)‡Fever ( °C)
Mild –easily tolerated 25–50 38.0– 38.9
Moderate –interferes with normal activity 51–100 39.0– 39.9
Severe –prevents normal activity >100 ≥ 40.0MenABCWY
0-6m
MenB -4C
0-2m
MenACWYCRM
(1 dose)
AE: adverse event; *Number of participants varies by study vaccination: 1428- 1638 for MenABCWY arm, 823- 835 for MenB -4C and 178 for MenACWY.
GSK, Data on File 2024N555060
Generally mild-to-moderate , with mean duration of 1 -4 days, depending on AE
Occurred at similar rates after MenABCWY and MenB -4C, and higher than after MenACWYCRM
No observed difference between 1st and 2nd dose MenABCWYInjection-
site pain†Swelling‡Induration‡Erythema‡Fatigue†Headache†Myalgia†Arthralgia†Nausea†Fever‡
1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2 1 2Solicited Local AEs Solicited Systemic AEsParticipants*
Dose
Phase 3: V72_72Solicited Local and Systemic AEs within 7 Days, after Each
Vaccination with MenABCWY, MenB- 4C or MenACWYCRM
10
Presentation by GSK at ACIP, June 2024MenABCWY Demonstrated a Well -Tolerated Safety Profile
Comparable to MenB- 4C
Integrated Safety Analysis (Pooled)
N =7,048MenABCWY
N=3,718MenB -4C
N=2,969MenACWYCRM
N=361
n (%) n (%) n (%)
Unsolicited AEs (within 30 days of any vaccination) 1,072 (29%) 736 (25%) 47 (13%)
Related* 256 (7%) 155 (6%) 10 (3%)
AEs leading to withdrawal 8 (0.2%) 4 (0.1%) 0
Medically attended AEs† 416 (12%) 302 (11%) 8 (4%)
Related medically attended AEs† 22 (0.6%) 15 (0.5%) 0
SAEs (entire study period) 70 (1.9%) 58 (2%) 5 (1.4%)
Related* 3 (0.1%) 2‡ (0.1%) 0
Deaths (all unrelated) 1§2¶1§
*Assigned as related by investigator; † Medically attended flags for AEs are not available in studies V102P1, V102_02, V102_02E1 and V102_03. Participants from these studies are not included. Therefore, the denominator
is different for the 3 groups (MenABCWY N=3488, MenB N=2861, MenACWY N=213); ‡ 2 SAEs occurred in the MenB -4C arms of the studies included in the pooled safety analysis: 1 SAE followed a MenB -4C and 1
followed a MenACWY -CRM vaccination; §Suicide; ¶ Deaths by poisoning and drug overdose; AE: adverse event; SAE: serious adverse event
GSK, Data on File 2024N555058.
11
Presentation by GSK at ACIP, June 2024Serogroup B Serogroups A C W YEvidence Supporting Safety and Immunogenicity of MenABCWY
Solicited and unsolicited adverse events after each dose of MenABCWY, MenB -4C or MenACWYCRM
Immunogenicity of MenABCWY against
110 serogroup B strains
GSK’s
MenABCWYImmunological noninferiority
ofMenABCWY vs MenB -4C
Persistence and booster immune
response up to 24 months
Solicited and unsolicited adverse events after each dose of MenABCWY, MenB -4C or MenACWYCRM
Non- inferiority vs MenACWYCRM
in MenACWY -naïve and -primed
Clinicaltrials.gov identifier NCT04502693 , accessed May 31st, 2024; Clinicaltrials.gov identifier NCT04707391 , accessed May 31st, 2024; Vesikari T et al. Hum Vaccin Immunother .2021;17(11):4689 -4700
12
Presentation by GSK at ACIP, June 2024Assays Used to Infer Meningococcal Vaccine Protection
hSBA, human serum bactericidal assay
1. CDC, 2022. About meningococcal vaccines. https://www.cdc.gov/vaccines/vpd/mening/hcp/about -vaccine.html ; 2. Donald RGK et al. Hum Vaccin Immunother .2017;13:255– 265; 3. Balmer P et al. Postgrad Med. 2020;132:184– 191;
4. Goldschneider I, et al. J Exp Med. 1969;129(6):1307 -1348; 5. Bröker M et al. Vaccine. 2009;27:5574– 5580; 6.Ferlito et al. Clin Exp Immunol . 2018;194(3): 361- 370; 6. Muzzi A et al. MSphere. 2022;e00385223
N. meningitidis
capsule polysaccharideMenACWY
Vaccines
hSBA against serogroup-
specific polysaccharide
capsule reference strain
infers protection against all
strains in serogroup2Vaccine targets Traditional hSBA
Highly abundant,
conserved
antigens1
Surrogate of protection:
titer ≥4 threshold for
protection2,3,4,5,6
13
Presentation by GSK at ACIP, June 202497.0 97.2 97.0 96.7
85.7
50.061.769.7
0%20%40%60%80%100%MenABCWY Non-Inferior to MenACWYCRM in MenACWY -Naïve and
MenACWY -Primed Participants
% with 4 -fold Rise
in hSBA Titers*†
(95% CI)
*At 1 month after 1 or 2 doses of MenABCWY or after single MenACWY vaccination; †Defined as a post -vaccination titer ≥4- fold the LOD or ≥LLOQ, whichever is greater if pre-vaccination titer <LOD, a post -vaccina tiontiter ≥4 -fold the LLOQ if pre- vaccination titer ≥LOD and <LLOQ, and
a post -vaccination titer ≥4- fold the pre- vaccination titer if pre -vaccination titer ≥LLOQ. LOD: 4 for MenA, MenC, MenW, and MenY. LLOQ =12 for MenA; 8 for MenC; 8 for MenW; 10 for MenY, except for the post -hoc analysis for which LLOQs were 8 for MenA and 11 for MenC;
‡Licensure criteria agreed with CBER; # full set analysis; **Primed participants had received a dose of MenACWY vaccine at least 4 years prior. CI –confidence interval, hSBA - human serum bactericidal assay, LOD – limit of detection; LLOQ – lower limit of quantitation
1. Clinicaltrials.gov identifier NCT04502693 , accessed May 31st, 2024; 2. Clinicaltrials.gov identifier NCT04707391 , accessed May 31st, 2024; 3. GSK, Data on File 2024N555056.75.2
64.572.6 74.885.1
50.962.470.2
0%20%40%60%80%100%
V72_72:
MenACWY -Naïve1 dose MenABCWY compared to 1 dose
MenACWYCRM#,3
95.2 94.4 95.6 95.0 95 94 93.9 94.4
0%20%40%60%80%100%
MenABCWY -019:
MenACWY -Primed**% with 4 -fold Rise
in hSBA Titers*†
(95% CI)
W Y A C
W Y A CSUCCESS CRITERION MET : LL of 95% CI > -10% 92.5 94.0 94.3 93.7 95 94 93.9 94.4
0%20%40%60%80%100%
SUCCESS CRITERION MET : LL of 95% CI > -10% Post hoc analysis
2 doses MenABCWY non-inferior
to 1 dose MenACWYCRM‡,21 dose MenABCWY non-inferior to 1 dose
MenACWYCRM2MenABCWY
(2 doses)
MenACWY
(1 dose)MenABCWY
(1stdose) W Y A C
W Y A CN=113 N=114 N=124 N=116 N=124 N=117 N=131 N=121 N=1,170 N=112 N=1,189 N=114 N=1,185 N=115 N=1,196 N=1192 doses MenABCWY non-inferior
to 1 dose MenACWYCRM‡,1
N=168 N=505 N=180 N=546 N=180 N=544 N=179 N=537 N=509 N=505 N=570 N=546 N=565 N=544 N=567 N=537SUCCESS CRITERION MET : LL of 95% CI > -10%
14
Presentation by GSK at ACIP, June 2024
GSK developed enc-hSBA5to
test against multiple serogroup B
strains
110 strains randomly selected
from 2000-2008 IMD cases, that continue to represent 95% of US
disease causing serogroup B strains
5collected up to 2017Assays Used to Infer Meningococcal Vaccine Protection
hSBA, human serum bactericidal activity; enc -hSBA, endogenous complements human serum bactericidal activity, Men, meningococcal serogroup; fHbp – factor H binding protein; NHBA – Neisserial Heparin Binding
Antigen; NadA – Neisseria Adhesin A; PorA1 P1.4 – porin A1 P1.4. *A MenB capsular vaccine was poorly immunogenic due to structural similarity between the capsule and human tissue5
1.CDC, 2022. About meningococcal vaccines. https://www.cdc.gov/vaccines/vpd/mening/hcp/about -vaccine.html ; 2. Donald RGK et al. Hum Vaccin Immunother .2017;13:255– 265; 3. Balmer P et al. Postgrad
Med.2020;132:184– 191; 4. Kleinschmidt A et al. NPJ Vaccines .2021;6:29; 5. Muzzi A et al. MSphere. 2022;e00385223
N. meningitidis
capsule polysaccharideMenACWY
Vaccines
N. meningitidis
subcapsular* proteins
hSBA against serogroup-
specific polysaccharide
capsule reference strain
infers protection against all
strains in serogroup2
hSBA does not assess
vaccine induced immune
response against many
diverse strains expressing
more than 1 antigen4
Vaccine targetsMenB
VaccinesfHbp
NHBA
PorA1
P1.4
NadATraditional hSBA
Highly abundant,
conserved antigens1
Variable
expression among
disease-causing
serogroup B
strains3
enc-hSBA
15
Presentation by GSK at ACIP, June 2024enc-hSBA: Immune Response Against Diverse Serogroup B
Strains in MenABCWY vs MenB -4C Arms
Immunological Vaccine Effectiveness (IVE)
*relative risk = ratio between % of tests lacking bactericidal activity against 110- strain panel in group receiving MenB -containi ng vaccine and control (MenACWY vaccine); †Target number of strains tested for each participant
was 35 strains out of the 110 strains panel . MenB: meningococcal serogroup B; enc-hSBA: endogenous complement serum bactericidal activity; IVE: immunological vaccine effectiveness
Welsch et al, Vaccine. 2018;36(15): 5309- 5317; Clinicaltrials.gov identifier NCT04502693 , accessed May 31st, 2024Percentage of participants whose
sera killed ≥70% of strains tested†
informs on breadth of MenB vaccine strain
coverage at a population level percentage of participants achieving broad
protection against serogroup B strainsTest-Based Responder -Based
IVE = (1 – relative risk) x 100
Relative risk defined as the percentage of tests
without bactericidal activity inthe group
receiving MenB -containing vaccine compared to
controls
16
Presentation by GSK at ACIP, June 2024enc-hSBA: Immune Response against Diverse Serogroup B
Strains after 2 doses of MenABCWY or MenB- 4C
The 3 MenB -4C schedules were hierarchically tested for IVE in the order: MenB -4C 0- 2-6m MenB -4C 0- 6mMenB -4C 0- 2m. The 0- 2m schedule was the last schedule to meet the predefined success criterion ( LL of 95% CI > 65%) and
was hence chosen as the comparator for the MenABCWY 0-6m schedule for all subsequent statistical analyses. LL, lower limit; IVE: immunological vaccine effectiveness
Clinicaltrials.gov identifier NCT04502693 , accessed May 31st, 2024
MenABCWY achieved breadth of bactericidal effect against a diverse and broad panel of serogroup B
strains, similar to MenB -4C 2-dose administered 2 or 6 months apart0%20%40%60%80%100%81.8
(80.4– 83.1)78.7
(77.2– 80.1)
vs MenACWYCRM control (4374 tests)MenB -4C 0,6m
(26,142 tests)MenB -4C 0,2m
(27,569 tests)MenABCWY 0,6m
(25,715 tests)77.9
(76.6– 79.2)
0%20%40%60%80%100%89.8
(87.2– 92.0)84.8
(81.8– 87.5)
MenB -4C0,6m
(813 participants)MenB -4C0,2m
(831 participants)MenABCWY 0,6m
(817 participants)84.1
(81.4– 86.5)
SUCCESS
CRITERION MET:
LL of 97.5% CI > 65% Test-Based IVE Responder -Based IVE
Informs breadth of MenB vaccine strain
coverage at a population level % participants achieving broad protection
against serogroup B strains
17
Presentation by GSK at ACIP, June 2024
MenABCWY was noninferior to MenB -4C, based on bactericidal effects against diverse strains
assessed by enc-hSBA assay
*The 3 MenB -4C schedules were hierarchically tested for IVE in the order: MenB -4C 0- 2-6m MenB -4C 0- 6mMenB -4C 0- 2m. The 0- 2m schedule was the last schedule to meet the predefined success criterion ( LL of 97.5%
CI > 65%) and was hence chosen as the comparator for the MenABCWY 0- 6m schedule for all subsequent statistical analyses. LL, lower limit
Clinicaltrials.gov identifier NCT04502693 , accessed May 31st, 2024enc-hSBA: Noninferiority of Immune Response against Diverse
Serogroup B Strains in MenABCWY vs MenB- 4C
0%20%40%60%80%100%
MenABCWY
(25,715 tests)MenB -4C 0,2m
(27,569 tests)-0.61
(-1.25 to 0.03)
SUCCESS CRITERION MET:
LL of 95% CI > - 5%
82.5%
(82.1- 83)85.6%
(85.1- 86)
% of Samples with
Bactericidal Serum
Activity
(95% CI)
MenB -4C 0,6m
(26,142 tests)83.1%
(82.7- 83.6)-3.02
(-3.65 to -2.39 )
18
Presentation by GSK at ACIP, June 202478.992.3
61.1
42.482.495.3
69.5
57.2
0%20%40%60%80%100%
N=693 N=729 N=699 N=725 N=700 N=731 N=704 N=664*
NHBA PorA P1.4 fHbp NadA% with 4 -fold Rise in hSBA Titers*
(95% CI)79.792.7
61.9
42.274.796.4
58.653.3
0%20%40%60%80%100%
NHBA PorA P1.4 fHbp NadA
MenABCWY 0,6m MenB -4C 0,2mN=675 N=719 N=671 N=717 N=678 N=718 N=642 N=704Group difference:
(95%CI)-3.53
(-7.6to 0.6)–3.01
(–5.6to –0.5)-8.31
(–13.2 to -3.4)–14.80
(–20.0 to –9.5)Group difference: (95%CI)5.02
(0.6 to 9.4)–3.68
(–6.2to –1.3)3.31
(–1.8to 8.4)–11.06
(–16.3 to –5.7)
MenABCWY 0,6m MenB -4C 0,6m
SUCCESS CRITERION:
LL of 95% CI > - 10%
% with 4 -fold Rise in hSBA Titers*
(95% CI)hSBA : MenABCWY Immune Response Against Serogroup B
Reference Strains
Secondary endpoint not met because success criterion not met for all 4 strains
MenABCWY elicited comparable immune responses for 3 reference strains vs MenB -4C 0,2 and 2 reference strains vs
MenB -4C 0,6m. MenABCWY 0,6m vs MenB -4C 0,2 m MenABCWY 0,6m vs MenB -4C 0,6 m
*At 1 month after 2nd MenABCWY or 2nd MenB -4C vaccination, relative to baseline. 4- fold rise in hSBA titer for each strain was defined as a post -vaccination titer ≥ 4-fold the LOD or ≥LLOQ, whichever is greater if pre-vaccination titer <LOD, a post -vaccination titer ≥4 -fold the LLOQ if pre-
vaccination titer ≥LOD and <LLOQ, and a post -vaccination titer ≥4- fold the pre- vaccination titer if pre -vaccination titer ≥LLOQ. LOD – limit of detection; LLOQ – lower limit of quantitation; LOD: fHbp: 3; NadA: 6; NHBA: 4; PorA P1.4: 4. LLOQ: fHbp: 5; NadA : 15; NHBA: 4; PorA P1.4: 6. fHbp,
factor H binding protein; hSBA, human serum bactericidal assay; LL, lower limit; LOD – limit of detection; LLOQ – lower limit of quantitation; NadA, Neisseria adhesin A; NHBA, Neisserial heparin- binding antigen; Por A P1.4, porin A
Clinicaltrials.gov identifier NCT04502693 , accessed May 31st, 2024
19
Presentation by GSK at ACIP, June 2024Serogroup B Serogroups A C W Y
Solicited and unsolicited adverse events after each dose of MenABCWY, MenB -4C or MenACWYCRM
Immunogenicity of MenABCWY against
110 serogroup B strains
GSK’s
MenABCWYImmunological noninferiority
ofMenABCWY vs MenB -4C
Persistence and booster immune
response up to 24 months
Solicited and unsolicited adverse events after each dose of MenABCWY, MenB -4C or MenACWYCRM
Non- inferiority vs MenACWYCRM
in MenACWY -naïve and -primed
Clinicaltrials.gov identifier NCT04502693 , accessed May 31st, 2024; Clinicaltrials.gov identifier NCT04707391 , accessed May 31st, 2024; Vesikari T et al. Hum Vaccin Immunother .2021;17(11):4689 -4700Evidence Supporting Safety and Immunogenicity of MenABCWY
20
Presentation by GSK at ACIP, June 2024020406080100
Baseline After 2 doses After 24m After booster020406080100
Baseline After 2 doses After 24m After boosterNHBAMenB -4C 0,2m (n=126) Persistence After 24 months and Booster Response of MenABCWY
Demonstrated Against Serogroup B Reference Strains
fHbp NadA
PorA% with hSBA
titers
≥ LLOQs
*For follow -on group: blood draws were done at baseline and 5 days after booster dose. For the Matched Naive group: blood draws were baseline ( prevaccination), 1 month after 1st dose and 5 days after 2nd dose. fHbp, factor H binding protein; hSBA, serum
bactericidal assay using human complement; LLOQ, lower limit of quantitation; NadA , Neisseria adhesin A; NHBA, Neisseria heparin binding antigen; PorA , porin A. The LLOQs were 8.0 ( fHbp), 8.6 ( NadA ), 8.9 (NHBA), 8.2 ( PorA ).
Vesikari T et al. Hum Vaccin Immunother .2021;17(11):4689 -4700
Study 15E1 MenABCWY 0,6m (n=74)
% with hSBA
titers
≥ LLOQs020406080100
Baseline After 2 doses After 24m After booster020406080100
Baseline After 2 doses After 24m After booster
Primary Study Extension Study* Primary Study Extension Study*
Primary Study Extension Study* Primary Study Extension Study*
21
Presentation by GSK at ACIP, June 2024
Combines two well -established vaccines licensed in the US - MenB -4C, MenACWYCRM
Clinical program demonstrated safety and immunogenicity in adolescents and young
adults
Tested against a broad panel of 110 serogroup B strains, representing 95% of US serogroup B disease-causing strains
Demonstrated persistence of immune response up to 24 monthsMenABCWY Summary
22
Presentation by GSK at ACIP, June 2024Summary of Data for Policy Considerations
2 doses of MenABCWY can protect against serogroups A,B,C W,Y
Achieves broad coverage against strains causing endemic and outbreak
disease, to meet the current and evolving US epidemiology
Offers the opportunity to improve vaccination coverage in adolescents and young adults
Represents the evolution of IMD as one vaccine- preventable disease
MenABCWY allows for prevention of IMD with one vaccine
Thank you!
Investigators, study site personnel,
study participants, and their families