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The National Institute for Biological Standards and Control

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  • Meningococcal disease

Meningococcal disease

The meningococcal group focuses on ensuring the safety and quality of a number of licensed meningococcal vaccines and producing standard reference reagents for epidemiology, research and commercial laboratories. 

The group also carries out vaccine-based research which includes:

  • developing and refining assays for quality control of licensed products
  • assessing novel vaccines at a pre-clinical stage
  • exploring the surface structure of the meningococcus to better understand the biological mechanisms which influence vaccine effectiveness

Our group is associated with many of the current meningococcal vaccine developments and provides expert advice to key stakeholders including product manufacturers, WHO and other regulatory bodies.

Standardisation

NIBSC provides a range of meningococcal reference materials designed for:

  • evaluating post-vaccination sera
  • typing of meningococcal isolates by epidemiology laboratories
  • quantitative standards for vaccine manufacturers and National Control Laboratories to determine polysaccharide content of vaccines

We evaluate reference material both in-house and through collaborative studies. NIBSC is keen to expand collaborations and develop new standards for the meningococcal community. Novel projects in consideration include nucleic acid typing standards for molecular typing laboratories, and reagents to support the implementation of Bexsero for both evaluation of vaccine serum and for quality control purposes.

Meningococcal vaccines

Neisseria meningitidis is a major cause of meningitis and septicaemia, especially in infants and young adults. Six serogroups (A, B, C, W, Y and X) account for most of the disease, and capsular polysaccharide vaccines offer protection against serogroups A, C, W and Y. A similar vaccine for group X is under development.

Serogroup B disease is the major cause of meningococcal disease in developed countries, however the serogroup B polysaccharide is poorly immunogenic, preventing a similar vaccine being developed for this group.  In 2012 a novel vaccine, Bexsero (see below), was licensed for the prevention of group B disease and will soon be used in immunisation programmes. 

Conjugate vaccines

Polysaccharide conjugate vaccines have superior immunogenicity to the plain polysaccharide vaccines and have an established safety and efficacy record, enabling physicochemical tests to be used to measure consistency and potency.

Tests carried out at NIBSC ensure:

  • potency, determined by total and unconjugated saccharide content
  • safety, determined by endotoxin content 
  • identity, determined by nuclear magnetic resonance (NMR) 
  • consistency, determined by high-performance liquid chromatography (HPLC) to measure the molecular size of the conjugate and assessment of vaccine appearance

Bexsero

Bexsero is a novel vaccine, licensed in 2012 for the prevention of group B disease and will soon be used in immunisation programmes. 

Bexsero is made up of three recombinant proteins expressed in E.coli and an outer membrane vesicle (OMV) derived from a meningococcal strain. OMVs naturally bleb from the surface of the meningococcus and contain phospholipids, outer membrane proteins and lipopoligosaccharide (endotoxin). The tests carried out at NIBSC ensure:

  • safety, confirmed using the monocyte activation test
  • potency,using an in vivo assay to demonstrate a batch is non-inferior to a defined reference batch
  • consistency, through measurement of LPS content, quantification of key OMV antigens and purity of recombinant antigens

Proteomics

The group has been involved in a number of proteomic projects involving the elucidation of the protein content of OMVs, analysis of the immune murine and human response to OMVs and identification of novel potential vaccine candidates.

We have used various techniques – including one- and two-dimensional SDS-PAGE, MALDI-TOF and tandem mass spectrometry and immunoblotting – alongside the NIBSC proteomics group and external collaborators from the Norwegian Institute of Public Health (NIPH), Professor Christoph Tang  and Dr Andrew Gorringe.

Overview of comparative meningococcal proteomics project using gel based Decyder™ technology

Overview of comparative meningococcal proteomics project using gel based Decyder™ technology

Manipulation of OMV formation for vaccine production

Understanding the biology of vesicle formation in the meningococcus is important in optimising the production and safety of OMV vaccines. The group has studied the mechanisms involved in vesicle formulation, in particular the function of reduction modifiable protein (RmpM), mutation of which leads to a blebbing phenotype.

Electron micrograph of native OMVs produced at NIBSC

Collaborators on these projects are Dr Sandra Sanchez and Dr Jeremy Derrick.

Novel vaccine candidates

The group has been involved in a number of collaborations investigating various approaches.

MenPF: an OMV vaccine based on PorA and FetA that has been used in a Phase I clinical trial.

This work was funded by a Strategic Translation Award 082102/Z/07/A by the Wellcome Trust to Prof Andrew Pollard, Prof Martin Maiden, Prof Jeremy Derrick and Prof Ian Feavers.

Viral vectors: Early studies of pre-clinical immunogenicity with PorA, FetA and fHbp in virus-like particles and an adenovirus vector.

Electron micrograph of VLPs courtesy J Derrick 

Iron uptake proteins:This project investigated different prerequisites that are key to supporting the case for haemoglobin receptors as potential vaccine candidates.

This work was funded by the Meningitis Research Foundation to Dr Chris Bayliss.

Key staff

Caroline Vipond
Dr Hannah Chan
Dr Rory Care

Available standards
ELISA reagents

98/722: Meningococcal group A polysaccharide
07/318: Meningococcal Group C Polysaccharide
01/426: Meningococcal group Y polysaccharide
01/428: Meningococcal group W135 polysaccharide
99/706: Anti-Meningococcal human reference serum CDC1992
12/176: Methylated Human Serum Albumin (mHSA)

Polysaccharides for quantitative assays

08/214: Neisseria meningitidis serogroup C polysaccharide (1st International Standard)
13/246: Neisseria meningitidis serogroup A polysaccharide (1st International Standard)
14/156: Neisseria meningitidis serogroup X polysaccharide (1st International Standard)

Serogrouping reagents

95/674: Anti-Meningococcal Serogroup A mAb
13/108: Anti-Meningococcal serogroup B monoclonal antibody
95/678: Anti-Meningococcal Serogroup C mAb
04/246: Anti-Meningococcal Serogroup W-135 mAb
12/284: Anti-meningococcal serogroup Y monoclonal antibody

Serosubtyping reagents

03/114: Anti-Meningococcal Serosubtype P1.1 mAb
02/178: Anti-Meningococcal Serosubtype P1.2 mAb
02/320: Anti-Meningococcal Serosubtype P1.3 mAb
02/148: Anti-Meningococcal Serosubtype P1.4 mAb
03/226: Anti-Meningococcal Serosubtype P1.5 mAb
03/210: Anti-Meningiococcal Serosubtype P1.6 mAb
01/514: Anti-Meningococcal Serosubtype P1.7 mAb
05/190: Anti Meningococcal Serosubtype P1.9 Monoclonal Antibody
03/224: Anti-Meningococcal Serosubtype P1.10 mAb
04/122: Anti-Meningococcal Serosubtype P1.12 mAb
03/236: Anti-Meningococcal Serosubtype P1.13 mAb
03/142: Anti-Meningococcal Serosubtype P1.14 mAb
02/144: Anti-Meningococcal Serosubtype P1.15 mAb
01/538: Anti-Meningococcal Serosubtype P1.16 mAb
04/248: Anti-Meningococcal Serosubtype P1.19 mAb

Serotyping reagents

02/180: Anti-Meningococcal Serotype P2.2a mAb
05/192: Anti Meningococcal Serotype P2.2b Monoclonal Antibody
04/198: Anti-Meningococcal Serotype P3.1 mAb
02/310: Anti-Meningococcal Serotype P3.15 mAb
03/182: Anti-Meningococcal Serotype P3.21 mAb

Other typing reagents

01/412: Anti-Meningococcal immunotype L3,7,9 mAb
09/170: Anti-Meningococcal factor H binding protein variant 1 (JAR4) monoclonal antibody
13/216: Anti-Meningococcal factor H binding protein variant 1 (JAR5) monoclonal antibody

14/156: Neisseria meningitidis serogroup X polysaccharide (1st International Standard)

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