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The National Institute for Biological Standards and Control

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  • Bacteriology

Bacteriology

Conjugate Vaccines

The Conjugate Vaccines group has a broad focus on conjugate, protein and mRNA vaccines against bacterial pathogens. Research includes novel conjugation technologies such as bioconjugation and Multiple Antigen Presenting Systems (MAPS), improving mucosal immunity through delivery mechanisms, adjuvants and formulations, as well as investigating combination protein/conjugate vaccines and mRNA-based vaccines.

Our research underpins the development of reference materials, analysis of human sera for International Standard pipelines, development of assays to understand correlates of protection, and establishing methodologies for analysing conjugate and mRNA vaccines. We focus on Haemophilus influenzae type B (Hib), as well as high priority pathogens Group A Streptococcus (Strep A, GAS), Group B Streptococcus (GBS), Salmonella enterica typhimurium and Klebsiella pneumoniae.

We are also involved in international consortia and collaborations to support vaccine development pipelines.

Recent publications

Recombinant production platform for Group A Streptococcus glycoconjugate vaccines

Sublingual immunisation with GBS serotype III capsular polysaccharide-tetanus toxoid conjugate vaccine induces systemic and mucosal antibody responses which are opsonophagocytic and inhibit GBS colonisation of vaginal epithelial cells

For more information contact:
fatme.mawas@mhra.gov.uk
arif.felak@mhra.gov.uk
alexandra.shaw@mhra.gov.uk

Vesicular Vaccines

The Vesicular Vaccines group focuses on major Gram-negative bacteria including Neisseria meningitidis, Neisseria gonorrhoeae, invasive non-typhoidal Salmonella, and Shigella, alongside targeted research projects on Streptococcus pneumoniae. These organisms cause substantial global disease and are primarily WHO priority pathogens with rising levels of antimicrobial resistance.

We develop reference materials for outer membrane vesicles (OMV)-based vaccines and emerging next-generation platforms such as Generalised Modules for Membrane Antigens (GMMA). We also develop analytical methods to characterise antigen content, structural integrity, and safety, such as the Monocyte Activation Test for pyrogenicity, and develop immunoassays that measure functional immune responses and contribute to defining correlates of protection.

By supporting vaccine developers and global health partners with reliable reference materials and methods for consistency, safety, and quality, we strengthen regulatory science for enteric, respiratory, and sexually transmitted pathogens and help accelerate the development of innovative vesicular vaccines

Recent Publications

Development of a Monocyte Activation Test as an alternative to the Rabbit Pyrogen Test for mono- and multi-component Shigella GMMA-based vaccines

Multi-laboratory study to evaluate the performance of a harmonised ELISA protocol to detect serum IGG specific for Shigella flexneri 2a LPS

For more information contact:
caroline.vipond@mhra.gov.uk

Respiratory Bacteria and Microbial Toxins

The Respiratory Bacteria and Microbial Toxins Group focus on bacterial diseases of the respiratory tract and those which cause illness through the production of toxins. These includes diphtheria, tetanus, pertussis, C. difficile, botulinum and tuberculosis (TB).

Our research involves developing new assays to ensure vaccine safety and efficacy by replacing outdated animal assays with more discriminative in vitro tests. We also focus on the development of novel vaccines such as nanoparticle-based vaccines for C. difficile and adenovirus vaccines for pertussis. We also work to support global health through testing for the WHO pre-qualification vaccine programme and botulinum toxin counterfeit testing for the MHRA enforcement team. On top of this, we also assist with the development of standards associated with these diseases. 

TB research links host–pathogen immunology with well-standardised preclinical testing to inform vaccine design and selection. Work spans host–Mycobacterium tuberculosis interactions across diverse strains, immunogenicity testing via different routes of immunisation, and in vivo efficacy assessment in established TB animal models. Capabilities include flow cytometry/FACS, multiplex cytokine platforms, and whole-genome/next-generation sequencing to characterise strains and support global head-to-head vaccine comparisons. In parallel, mechanisms of TB dissemination from the lung to the brain and central nervous system involvement are investigated.

Recent publications

Adenoviral-vectored vaccine against Bordetella pertussis fimbrial antigen induces partial protection in a mouse model

Efficacy and immunogenicity of different BCG doses in BALB/c and CB6F1 mice when challenged with H37Rv or Beijing HN878

For more information contact:
kevin.markey@mhra.gov.uk

 
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