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Meningococcal

4CMenB journey to the 10-year anniversary and beyond

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Article: 2357924 | Received 19 Oct 2023, Accepted 17 May 2024, Published online: 08 Jul 2024

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Figure 1. Road map leading to the regulatory approval and distribution of 4CMenB in more than 50 countries worldwideCitation9–11 and to the inclusion of 4CMenB in national and regional immunization programs since initial registration.

*Adolescents/young adults (age 15–24 years) who wish to be vaccinated. 4CMenB, 4-component MenB vaccine; EU, European Union; MenB, meningococcal serogroup B; NIP, national immunization program; RIP, regional immunization program; SCDM, shared clinical decision-making; SmPC, summary of product characteristics; UK, United Kingdom; US, United States.
Figure 1. Road map leading to the regulatory approval and distribution of 4CMenB in more than 50 countries worldwideCitation9–11 and to the inclusion of 4CMenB in national and regional immunization programs since initial registration.

Figure 2. Recommendations in 16 national immunization programs for the coadministration (co-adm) of routine childhood vaccines with 4CMenB and the use of prophylactic paracetamol (known as acetaminophen in the United States).Citation52,Citation53

4CMenB, 4-component MenB vaccine; UK, United Kingdom.
Figure 2. Recommendations in 16 national immunization programs for the coadministration (co-adm) of routine childhood vaccines with 4CMenB and the use of prophylactic paracetamol (known as acetaminophen in the United States).Citation52,Citation53

Figure 3. Real-world evidence of the effectiveness, impact, and safety of 4CMenB.

A. Vaccine effectiveness and vaccine impact against invasive meningococcal serogroup B (MenB) disease.
B. Safety profile of 4CMenB.
C. Effectiveness against non-B meningococcal disease and gonococcal disease.
4CMenB, 4-component MenB vaccine; AE, adverse event; AEFI, AE following immunization; aIRR, adjusted IRR; CI, confidence interval; IMD, invasive meningococcal disease; IRR, incidence rate ratio; MenACWY, meningococcal serogroup ACWY vaccine; MenB, meningococcal serogroup B; MenB-FHbp, MenB-factor H binding protein vaccine; MenW, meningococcal serogroup W; MSM, men who have sex with men; NIP, national immunization program; OMV, outer membrane vesicles; OR, odds ratio; PLWH, people living with HIV; RIP, regional immunization program; SAE, serious AE; SLSJ, Saguenay-Lac-Saint-Jean; SmPC, summary of product characteristics; UK, United Kingdom; US, United States; VE, vaccine effectiveness.
Figure 3. Real-world evidence of the effectiveness, impact, and safety of 4CMenB.

Figure 4. Observed and projected serogroup B invasive disease cases in South Australia before (2003–2016) and after 4CMenB vaccination of students aged 16–19 years as part of the ‘B part of It’ program.Citation78

4CMenB, 4-component MenB vaccine; CI, confidence interval; MenB, meningococcal serogroup B; PI, predicted interval.
Figure 4. Observed and projected serogroup B invasive disease cases in South Australia before (2003–2016) and after 4CMenB vaccination of students aged 16–19 years as part of the ‘B part of It’ program.Citation78

Figure 5. Ongoing and completed studies on the potential for 4CMenB to protect against Neisseria gonorrhoeae infection.

* presents real-world evidence of the effectiveness and impact of 4CMenB in completed studies.
†Study supported by GSK.
Vaccine efficacy 22% (95% CI: -1–40) against gonorrhea infection. Results inconclusive; some benefits could not be ruled out.
4CMenB, 4-component MenB vaccine; ANRS, National French Agency for Research on AIDS; CDC, Centers for Disease Control and Prevention; MSM, men who have sex with men; MSSS, Ministry of Health and Social Services, Quebec; N, number of enrolled participants (actual number for completed studies; planned number for ongoing studies); NIAID, National Institute of Allergy and Infectious Diseases; PrEP, pre-exposure prophylaxis; RCT, randomized controlled trial; SA, South Australia; SLSJ, Saguenay-Lac-Saint-Jean; STI, sexually transmitted infection; US, United States.
Figure 5. Ongoing and completed studies on the potential for 4CMenB to protect against Neisseria gonorrhoeae infection.

Figure 6. Potential coverage of 4CMenB against MenB strains circulating worldwide, as predicted by Meningococcal Antigen Typing System (MATS).

4CMenB, 4-component meningococcal serogroup B vaccine; CI, confidence interval; Eng/Wal/NI, England, Wales, and Northern Ireland; MenB, meningococcal serogroup B; US, United States.
Figure 6. Potential coverage of 4CMenB against MenB strains circulating worldwide, as predicted by Meningococcal Antigen Typing System (MATS).

Figure 7. Characteristics of the traditional human serum bactericidal antibody (hSBA) assay and the endogenous complement hSBA (enc-hSBA) in relation to the assessment of meningococcal serogroup B (MenB) vaccines.Citation159,Citation184–186.

Enc-hSBA, endogenous complement hSBA; hSBA, human serum bactericidal antibody; MenB, meningococcal serogroup B.
Figure 7. Characteristics of the traditional human serum bactericidal antibody (hSBA) assay and the endogenous complement hSBA (enc-hSBA) in relation to the assessment of meningococcal serogroup B (MenB) vaccines.Citation159,Citation184–186.
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