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Work Group Considerations Regarding MenABCWY Vaccine and
Discussion of Potential Risk Groups for MenB Vaccination
Sarah F. Schillie , MD, MPH, MBA
DBD/NCIRD
Advisory Committee on Immunization Practices
June 28, 2024
The findings and conclusions in this presentation are those of the authors and do not necessarily represent the official posi tion of the
Centers for Disease Control and Prevention
CONFIDENTIAL
GSK’s MenABCWY Vaccine Clinical Development Program
Phase 3 studies
•V72_72: ages 10 – 25 years, MenACWY- naïve/ MenB- naïve, N=3,638
•87-9 1% White*; 3 -6% Hispanic or Latino*; 49 -56% female
•MenABCWY -0 19: ages 15–25 years, MenACWY- primed/ MenB- naïve, N=1,247
•75-76% White*; 29- 31% Hispanic or Latino*; 52 -55% female
•Comparators: Me nACWY -CRM, MenB -4C 0,2 mo., MenB -4C 0,6 mo.
10 Phase 1 and 2 studies
*Demographics of participants reflect countries in which studies performed2 of 32
Assessment of Safety
Phase 3 studies
•Solicited local and systemic AEs after each dose of Me nABCWY , MenACWY , and
MenB
Integrated Safety Analysis (N=7,048)
•Unsolicited AEs within 30 days of vaccination
•Related, leading to withdrawal, medically attended, related medically attended,
S
AEs, deaths
AE, adverse event; SAE, serious adverse event3 of 32
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Solicited AE:
•Local AE: Me nABCWY≈MenB and MenABCWY >MenACWY
•Systemic AE: MenABCWY≈MenB≈MenACWY
Unsolicited AE:
•MenABCWY s lightly greater than MenB and greater than
MenACWY
•Except for AE leading to withdrawal during the entire study period:
Me
nABCWY≈MenB <MenACWY
AE, adverse eventSolicited and Unsolicited AE Following Vaccination
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SAEs and Deaths
SAE during entire study period: Me nABCWY≈MenB>MenACWY
(all ≤2%)
•Related SAE during entire study period: MenABCWY≈MenB >Me nACWY (all ≤0.1%)
•4 of 5 resolved or partially resolved (seizure*, connective tissue disorder*,
ne
uromyelitis optica *, pyrexia/nausea/vomiting/ headache¥)
•1 ongoing (ulcerative colitis† with positive family history for Crohn’s disease)
Deaths (all unrelated)
•MenABCWY r ecipients (1): suicide
•MenB r ecipients (2): drug overdose, poisoning
•MenACWY r ecipients (1): suicide
*MenABCWY vaccine recipient, ¥MenACWY recipient, † MenB recipient
SAE, serious adverse event7 of 32
Immunogenicity Assessment
Serogroup A, C, W, Y
•Seroresponse: 4- f old rise in hSBA titers
Serogroup B
•Seroresponse: 4- f old rise in hSBA titers
•enc-h SBA assay: Assessment of protection against diverse disease-
causing serogroup B strains
•110 randomly selected strains that represent 95% of U.S. “disease-
c
ausing” strains
enc- hSBA , endogenous complement hSBA8 of 32
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2 doses Me nABCWY non-
inferior to 1 dose
MenACWY
•MenACWY- n aïve and primed
recipients
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1 do se MenABCWY non- inferior
to 1 dose MenACWY in
MenACWY -primed recipients
•Naïve recipients: ad hoc analysis;
confidence intervals overlap for all 4 serogroups
•Responses greater for MenABCWY
recipients compared to MenACWY
recipients
•Except for serogroup A (rare in U.S.)
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MenABCWY v s. MenB 0,2:
•Success criterion met for 3
o
f 4 strains ( fHbp, NadA ,
NHBA)
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MenABCWY v s. MenB 0,6:
•Success criterion met for 2
o
f 4 strains ( fHbp, NadA )
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Immunogenicity for Serogroup B: enc- hSBA
Success criterion met
•Compared to M enB 0,2 and MenB 0,6
•Test-b ased and responder- based IVE
Response slightly higher for Me nB vs. MenABCWY
•Slightly higher for MenB 0,6 v s. MenB 0,2
IVE, immunological vaccine effectiveness
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Persistence and Booster Response
•
•
•
•
•MenB
After 24 months, titers waned substantially for B strains fHbp, NHBA,
and PorA
Robust booster response elicited
Confidence intervals overlapped ( Me nABCWY and MenB 0,2)
MenACWY
After 24 months, titers waned substantially for serogroup A; variable
waning noted for other serogroups
Robust booster response elicited
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Summary
Favorable safety profile
•Similar to Me nB (more adverse events for MenABCWY than MenACWY)
Immunogenicity against serogroups A, C, W, Y
•MenABCWY n on-inferior to MenACWY in most study groups
•Comparison of 1 dose MenABCWY v s. 1 dose MenACWY in naïve recipients not
powered for noninferiority; results favorable for all serogroups except A
Immunogenicity against serogroup B strains
•MenABCWY n on-inferior to MenB based on IVE
•MenABCWY n on-inferior to MenB 0,2 for 3 strains and MenB 0,6 for 2 strains
Persistence and booster response
•After 24 months, titers waned substantially for serogroup A and for 3 B strains
•Robust booster response elicitedIVE, immunologic vaccine effectiveness 20 of 32
Additional Work Group Reflections
Concern about drop in protection at 2 years for serogroup B
s
trains
PorA indic ator strain is important because it is not really PorA
alone but rather represents the full outer membrane vesicle component of the vaccine
•Response to this indicator strain has bearing on cross -p rotection
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Potential Risk Groups for
MenB Vaccination
Schedule Options Under Consideration
OptionACWY
Dose#1ACWY Dose#2B Dose#1 B Dose#2
Current
recomm .11–12 yrs 16 yrs16 yrs – 23 years (preferred 16–18 yrs)
SCDM
1 11–12 yrs 16 yrs 16 yrs 17–18 yrs
2 11–12 yrs 16 yrs 16 yrs risk-based 17–18 yrs risk-based
3 No dose 16 yrs 16 yrs risk -based 17–18 yrs risk-based
4 15 yrs 17–18 yrs 17–18 yrs 17–18 yrs
5 (ACIP) No dose 16 yrs 16 yrs 17–18 yrs
Proposed recommendations are for routine vaccination unless specified as “risk -based”; option numbers do not represent ordering of preference
SCDM, shared clinical decision -making23 of 32
Identify Risk Groups for MenB Vaccination
Based on congregate living settings among
ad
olescents
•Recommendations will not address military/non- c ivilian
populations as per the ACIP charter
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•College students (4 -y ear students, 1st year students, on- campus residence)
•Boarding schools
•Congregate foster care
•Correctional or detention facilities
•Homeless or emergency shelters
•Institutions for persons with developmental disabilities
•Psychiatric institutions
•Residential treatment centers
•Religious academies
•Wilderness programs, summer camps
•Seasonal worker housing (including agricultural workers)
•College preparatory experiences
•Hotels, motels, and hostelsPotential Risk Groups for MenB Vaccination
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•College students (4 -y ear students, 1st year students, on- campus residence)
•Boarding schools
•Congregate foster care
•Correctional or d etention facilities
•Homeless or emergency shelters
•Institutions for persons with developmental disabilities
•Psychiatric institutions
•Residential treatment centers
•Religious academies
•Wilderness programs, summer camps
•Seasonal worker housing (including agricultural workers)
•College preparatory experiences
•Hotels, motels, and hostelsDuration of Congregate Living Risk Should
Exceed Time to Complete Vaccine Series
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Factors Associated with Increased Serogroup B Risk
among College Students
4-y ear college students had a 5.2-fold (95% CI: 3.6- 7.7) higher risk of serogroup B
disease than non- undergraduates aged 18 -24 years
•Risk among 2 -y ear college students was comparable to non -undergraduates (RR 1.0, 95% CI
0.4-2.1)
First -y ear students were at 3.8- fold (95% CI: 2.4- 6.0) higher risk of serogroup B
disease than non- first-year students
On-c ampus residents were at 2.9-fold (95% CI: 1.8- 4.6) higher risk of serogroup B
disease than off- campus residents
Students participating in Greek life were at 9.8 -fold (95% CI: 4.6- 21.2) higher risk of
serogroup B disease than other students during outbreaks
Weil LW, Crowe SJ, Rubis AB, Soeters HM, Meyer SA, Hariri S, McNamara LA. Risk Factors for Serogroup B Meningococcal Disease Among College Students, Open Forum Infectious
Diseases. 2023; https://doi.org/10.1093/ofid/ofad607
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College Students
Work Group prefers to include all college students
•Simplifies recommendations
•College plans may change
•Equity considerations
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Number of Students at U.S. Colleges and Boarding Schools
Number of 18 y ear-olds (in 2020): 4,159,857
Recent high school completers* in 2022: 2,987,000
•Percentage of recent high school completers enrolled in college: 62.0%
•2-y ear college: 16.9%
•4-y ear college or university: 45.1%
>35,000 students enrolled in U.S. boarding schools
•Older students, many may be likely to attend college
*Includes those who completed a GED or other high school equivalency credential
GED, General Educational Development
Bridged -Race Population Estimates 1990 -2020 Results Form (cdc.gov)
Number of recent high school completers and percent enrolled in college, by sex and level of institution: 1960 through 2022
Why Kids Go to Boarding School (usnews.com)29 of 32
Public Foster Care System
Continuum of foster care
•Includes children through 18 –2 1 years (varies by state)
•Fo ster family home, group home, residential program
•May or may not include congregate care settings
Public foster care system served 570,000 children in 2022
•369,000 children in care on September 30, 2022
Federal law requires children to be placed in least restrictive, most
f
amily-like setting
•Number placed in congregate care decreasing
•Those in congregate foster care typically spend ~8 months
Children’s Bureau, Administration for Children and Families, U.S. Department of Health and Human Services Trends in Foster Care and Adoption: FY 2013 – 2022 | The
Administration for Children and Families (hhs.gov) 30 of 32
Inclusive Language
Work Group prefers to add inclusive language to
risk-
groups
•Such that any adolescent who desires protection may receive
Me
nB vaccine
•Includes those who are unsure of their future plans , which may
inform congregate living risk
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Risk group includes adolescents planning to attend college and
a
dolescents in a congregate living setting (e.g., congregate
foster care, boarding school, correctional facility, etc.) who are anticipated to remain in this setting long enough to complete the MenB vaccine series
Any adolescent who desires protection may receive Me
nB
vaccine, even if they are unsure of their future plans which
may inform congregate living riskProposed Language
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