Characteristics of a new meningococcal serogroup B vaccine, bivalent rLP2086 (MenB-FHbp; Trumenba®)

Gandhi, Ashesh; Balmer, Paul; York, Laura J.

doi:10.1080/00325481.2016.1203238

Cited by 75 publications

(51 citation statements)

References 70 publications

(115 reference statements)

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“…The bivalent fHbp vaccine, rLP2086, comprises variant 1 and variant 3 fHbp peptide components, the latter of which may be cross-protective against meningococci with variant 2, as well as those with variant 3, peptides 21 . Strain coverage afforded by the bivalent fHbp vaccine is predicted using the Meningococcal Antigen Surface Expression (MeASurE) flow cytometric assay which quantifies fHbp surface expression 22 …”

Section: Introductionmentioning

confidence: 99%

Frequent capsule switching in ‘ultra-virulent’ meningococci – Are we ready for a serogroup B ST-11 complex outbreak?

Lucidarme

Lekshmi

Parikh

et al. 2017

Journal of Infection

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SummaryThe meningococcal ST-11 complex (cc11) causes large invasive disease outbreaks with high case fatality rates, such as serogroup C (MenC) epidemics in industrialised nations in the 1990s and the serogroup W epidemic currently expanding globally. Glycoconjugate vaccines are available for serogroups A, C, W and Y. Broad coverage protein-based vaccines have recently been licensed against serogroup B meningococci (MenB), however, these do not afford universal MenB protection. Capsular switching from MenC to MenB among cc11 organisms is concerning because a large MenB cc11 (B:cc11) outbreak has the potential to cause significant morbidity and mortality. This study aimed to assess the potential for licensed and developmental non-capsular meningococcal vaccines to protect against B:cc11. The population structure and vaccine antigen distribution was determined for a panel of >800 geo-temporally diverse, predominantly MenC cc11 and B:cc11 genomes. The two licensed vaccines potentially protect against many but not all B:cc11 meningococci. Furthermore, strain coverage by these vaccines is often due to a single vaccine antigen and both vaccines are highly susceptible to vaccine escape owing to the apparent dispensability of key proteins used as vaccine antigens. cc11 strains with MenB and MenC capsules warrant special consideration when formulating future non-capsular meningococcal vaccines.

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Section: Introductionmentioning

confidence: 99%

Frequent capsule switching in ‘ultra-virulent’ meningococci – Are we ready for a serogroup B ST-11 complex outbreak?

Lucidarme

Lekshmi

Parikh

et al. 2017

Journal of Infection

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“…Antibodies directed against fHbp are bactericidal, and can both activate the complement cascade, and block the recruitment of fH by bacteria [5, 6, 9–13]. fHbp is included in licensed protein-based vaccines against group B meningococcus [14, 15]. …”

Section: Introductionmentioning

confidence: 99%

Contribution of factor H-Binding protein sequence to the cross-reactivity of meningococcal native outer membrane vesicle vaccines with over-expressed fHbp variant group 1

et al. 2017

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Factor H-binding protein (fHbp) is an important meningococcal vaccine antigen. Native outer membrane vesicles with over-expressed fHbp (NOMV OE fHbp) have been shown to induce antibodies with broader functional activity than recombinant fHbp (rfHbp). Improved understanding of this broad coverage would facilitate rational vaccine design. We performed a pair-wise analysis of 48 surface-exposed amino acids involved in interacting with factor H, among 383 fHbp variant group 1 sequences. We generated isogenic NOMV-producing meningococcal strains from an African serogroup W isolate, each over-expressing one of four fHbp variant group 1 sequences (ID 1, 5, 9, or 74), including those most common among invasive African meningococcal isolates. Mice were immunised with each NOMV, and sera tested for IgG levels against each of the rfHbp ID and for ability to kill a panel of heterologous meningococcal isolates. At the fH-binding site, ID pairs differed by a maximum of 13 (27%) amino acids. ID 9 shared an amino acid sequence common to 83 ID types. The selected ID types differed by up to 6 amino acids, in the fH-binding site. All NOMV and rfHbp induced high IgG levels against each rfHbp. Serum killing from mice immunised with rfHbp was generally less efficient and more restricted compared to NOMV, which induced antibodies that killed most meningococci tested, with decreased stringency for ID type differences. Breadth of killing was mostly due to anti-fHbp antibodies, with some restriction according to ID type sequence differences. Nevertheless, under our experimental conditions, no relationship between antibody cross-reactivity and variation fH-binding site sequence was identified. NOMV over-expressing different fHbp IDs belonging to variant group 1 induce antibodies with fine specificities against fHbp, and ability to kill broadly meningococci expressing heterologous fHbp IDs. The work reinforces that meningococcal NOMV with OE fHbp is a promising vaccine strategy, and provides a basis for rational selection of antigen sequence types for over-expression on NOMV.

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“…Methodology of performing serum bactericidal assays using human complement. (Adapted with permission from Gandhi et al)…”

Section: Resultsmentioning

confidence: 99%

A review of the immunogenicity, safety and current recommendations for the meningococcal serogroup B vaccine, MenB‐FHbp

Alderfer

Snow

2019

J Clin Pharm Ther

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What is known and objective This review describes invasive meningococcal disease (IMD) epidemiology in the United States, provides a brief overview of available meningococcal vaccines and discusses meningococcal serogroup B (MenB) vaccine development. Particular focus is given to the recombinant protein MenB vaccine, MenB‐FHbp (Trumenba®, bivalent rLP2086) in light of recent publication of phase 3 data; the other MenB vaccine (Bexsero®, MenB‐4C) has been recently reviewed. Current recommendations of the US Advisory Committee on Immunization Practices (ACIP) for MenB vaccination and potential barriers to immunization are also discussed. Methods Using the published literature, this article reviews the development and use of MenB‐FHbp to date, with a focus on the United States. Results and discussion Despite the availability of medical treatment, IMD is associated with significant mortality and frequently occurring serious permanent sequelae in surviving individuals. Worldwide, most IMD is caused by six serogroups (A, B, C, W, X and Y). MenB is the most common disease‐causing meningococcal serogroup in the United States and has caused several recent university‐based IMD outbreaks. MenB vaccines, including MenB‐FHbp, are available in the United States. ACIP recommends that all individuals ≥10 years of age at increased risk for meningococcal disease receive MenB vaccination; healthy individuals 16‐23 years of age are recommended MenB vaccines based on individual clinical decision‐making. MenB‐FHbp is used on a 2‐dose schedule (0, 6 months) when vaccinating healthy individuals and on a tailored 3‐dose schedule (0, 1‒2, 6 months) in cases of increased risk. What is new and conclusion Because vaccination provides the most effective protection against IMD, pharmacists are in an excellent position to offer evidence‐based vaccine information, as well as to encourage and provide meningococcal immunizations to adolescents and young adults.

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Characteristics of a new meningococcal serogroup B vaccine, bivalent rLP2086 (MenB-FHbp; Trumenba®)

Cited by 75 publications

References 70 publications

Frequent capsule switching in ‘ultra-virulent’ meningococci – Are we ready for a serogroup B ST-11 complex outbreak?

Frequent capsule switching in ‘ultra-virulent’ meningococci – Are we ready for a serogroup B ST-11 complex outbreak?

Contribution of factor H-Binding protein sequence to the cross-reactivity of meningococcal native outer membrane vesicle vaccines with over-expressed fHbp variant group 1

A review of the immunogenicity, safety and current recommendations for the meningococcal serogroup B vaccine, MenB‐FHbp

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