Immunogenicity and Safety of Investigational MenABCWY Vaccine and of 4CMenB and MenACWY Vaccines Administered Concomitantly or Alone: a Phase 2 Randomized Study of Adolescents and Young Adults

Beran, Jiřı́; Dražan, Daniel; Enweonye, Igwebuike; Bhusal, Chiranjiwi; Toneatto, Daniela

doi:10.1128/msphere.00553-21

Cited by 10 publications

(3 citation statements)

References 12 publications

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“…Both 4CMenB and MenB-FHbp are components of pentavalent MenABCWY meningococcal vaccines under development [ 146 , 147 ] . While clinical studies evaluate immunogenicity and safety in younger adults (up to 25 years), these are reported as pooled data incorporating data from adolescents [ 148 , 149 ]. As such, at the present time, no additional insight into specific adult immunogenicity data can be drawn from these programmes.…”

Section: Menb Vaccinesmentioning

confidence: 99%

Meningococcal B Immunisation in Adults and Potential Broader Immunisation Strategies: A Narrative Review

et al. 2023

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Recombinant vaccines against invasive meningococcal disease due to Neisseria meningitidis serogroup B (MenB) have shown substantial impact in reducing MenB disease in targeted populations. 4CMenB targets four key N. meningitidis protein antigens; human factor H binding protein (fHbp), Neisserial heparin binding antigen (NHBA), Neisseria adhesin A (NadA) and the porin A protein (PorA P1.4), with one or more of these expressed by most pathogenic MenB strains, while MenB-FHbp targets two distinct fHbp variants. While many countries recommend MenB immunisation in adults considered at high risk due to underlying medical conditions or immunosuppression, there are no recommendations for routine use in the general adult population. We reviewed the burden of MenB in adults, where, while incidence rates remain low (and far lower than in young children < 5 years of age at greatest risk), a substantial proportion of MenB cases (20% or more) is now observed in the adult population; evident in Europe, Australia, and in the United States. We also reviewed immunogenicity data in adults from clinical studies conducted during MenB vaccine development and subsequent post-licensure studies. A 2-dose schedule of 4CMenB generates hSBA titres ≥ 1:4 towards all four key vaccine target antigens in up to 98–100% of subjects. For MenB-FHbp, a ≥ fourfold rise in hSBA titres against the four primary representative test strains was observed in 70–95% of recipients following a 3-dose schedule. While this suggests potential benefits for MenB immunisation if used in adult populations, data are limited (especially for adults > 50 years) and key aspects relating to duration of protection remain unclear. Although a broader adult MenB immunisation policy could provide greater protection of the adult population, additional data are required to support policy decision-making. Graphical Abstract

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Section: Menb Vaccinesmentioning

confidence: 99%

Meningococcal B Immunisation in Adults and Potential Broader Immunisation Strategies: A Narrative Review

et al. 2023

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“…Novel pentavalent vaccines are in clinical development. These include a pentavalent vaccine targeting MenX (i.e., MenACWY and X), principally to address MenW emergence in sub-Saharan Africa [114,115], and vaccines combining 4CMenB or MenB-FHbp vaccine components with MenACWY elements as MenABCWY formulations [116][117][118]. These pentavalent vaccines are in the latter stages of clinical development and could be available within the next 5 years.…”

Section: Additional Immunization Considerationsmentioning

confidence: 99%

Meningococcal Disease and Immunization Activities in Hajj and Umrah Pilgrimage: a review

Badur¹,

Khalaf²,

Öztürk³

et al. 2022

Infect Dis Ther

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Invasive meningococcal disease (IMD) outbreaks associated with Hajj and Umrah pilgrimage events in the Kingdom of Saudi Arabia (KSA) are well recognized. Past outbreaks have been associated with substantial intercontinental spread of specific Neisseria meningitidis serogroups. The emergence of meningococcal serogroup W (MenW) was a global concern following the 2000/2001 Hajj outbreaks. Broader compulsory meningococcal serogroups A, C, W and Y (MenACWY) immunization S. Badur (&) EM, Vaccines Scientific Affairs and Public Health, GSK, Bu ¨yu ¨kdere Caddesi No:173,

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“…Tapia et al suggested that the NmCV-5 pentavalent vaccine could provide immunity in toddlers after a single dose, without safety concerns. An investigational meningococcal ABCWY vaccine (MenABCWY) that is made up of components of vaccines against meningococcal serogroup B (4CMenB) and serogroups ACWY (MenACWY) is being developed; recent studies demonstrated its immunogenicity and its safety profile in adolescents [ 82 , 83 ].…”

Section: Looking To the Futurementioning

confidence: 99%

Meningococcal Disease in Pediatric Age: A Focus on Epidemiology and Prevention

Pietro

Biffi

Castellazzi

et al. 2022

IJERPH

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Meningococcal disease is caused by Neisseria meningitidis; 13 serogroups have been identified and differentiated from each other through their capsular polysaccharide. Serotypes A, B, C, W, X, and Y are responsible for nearly all infections worldwide. The most common clinical manifestations are meningitis and invasive meningococcal disease, both characterized by high mortality and long-term sequelae. The infection rate is higher in children younger than 1 year and in adolescents, who are frequently asymptomatic carriers. Vaccination is the most effective method of preventing infection and transmission. Currently, both monovalent meningococcal vaccines (against A, B, and C serotypes) and quadrivalent meningococcal vaccines (against serogroups ACYW) are available and recommended according to local epidemiology. The purpose of this article is to describe the meningococcal vaccines and to identify instruments that are useful for reducing transmission and implementing the vaccination coverage. This aim could be reached by switching from the monovalent to the quadrivalent vaccine in the first year of life, increasing vaccine promotion against ACYW serotypes among adolescents, and extending the free offer of the anti-meningococcal B vaccine to teens, co-administering it with others proposed in the same age group. Greater awareness of the severity of the disease and increased health education through web and social networks could represent the best strategies for promoting adhesion and active participation in the vaccination campaign. Finally, the development of a licensed universal meningococcal vaccine should be another important objective.

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Immunogenicity and Safety of Investigational MenABCWY Vaccine and of 4CMenB and MenACWY Vaccines Administered Concomitantly or Alone: a Phase 2 Randomized Study of Adolescents and Young Adults

Abstract: The bacterial species Neisseria meningitidis is a major cause of meningitis, with six meningococcal groups (serogroups) causing most cases. A licensed vaccine, MenACWY (Menveo), targets four of these meningococcal serogroups, and another vaccine, 4CMenB (Bexsero), targets serogroup B.

Cited by 10 publications

References 12 publications

Meningococcal B Immunisation in Adults and Potential Broader Immunisation Strategies: A Narrative Review

Meningococcal B Immunisation in Adults and Potential Broader Immunisation Strategies: A Narrative Review

Meningococcal Disease and Immunization Activities in Hajj and Umrah Pilgrimage: a review

Meningococcal Disease in Pediatric Age: A Focus on Epidemiology and Prevention

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