Completed Infection & Immunity Pregnancy, Children & Inherited Conditions

A novel vaccine for broad protection against meningococcal disease: progression to phase I clinical trial

In plain English

AI plain-English summary

A single dose of a new meningitis vaccine has already produced strong antibody responses in animal tests, and the researchers now plan to test it in humans. This matters because the current leading cause of infectious death in UK children—serogroup B meningococcal disease—has no fully satisfactory vaccine. The recently licensed version requires up to four injections and was judged not cost-effective for infant immunisation. Another candidate targets only adolescents. Infants under one year old, who face the highest risk, remain inadequately protected. The new vaccine uses a delivery platform never before applied to bacterial outer membrane proteins. In pre-clinical models, it triggered both innate and adaptive immune responses, including the type of antibody that kills meningococcal bacteria directly. If the phase I trial succeeds, the vaccine could eventually offer broader, cheaper, and simpler protection for the most vulnerable age group, potentially reducing the number of injections needed and lowering production costs.

View original technical description
The aim of this project is to progress a novel vaccine against serogroup B meningococcal disease (MenB) to phase I clinical trial. MenB disease is the leading infectious cause of death in children in the UK. Two vaccine candidates are under development or recently licensed, based on recombinant proteins and outer membrane vesicles. The recently licensed vaccine was not considered to be cost-effective for infant immunisation in one recent analysis, as it requires up to 4 injections, and the other one is being developed for use in adolescents only. Therefore both have serious limitations if protection is to be provided for the population at most risk: infants under one year of age. Ongoing development of alternative or improved vaccine candidates is therefore required to reduce the cost of vaccine production and delivery. Our proposed solution is to use a novel vaccine platform to deliver a major meningococcal antigen-target to the immune system. This approach is new as the delivery platform has never been used before for inducing antibody responses against bacterial outer membrane proteins. The rational is that the novel vaccine delivery system induces both innate and adaptive immune responses in mammalian hosts, including robust IFN-gamma responses, thought to provide the ideal conditions for switching B cells to produce complement-fixing bactericidal antibody, unlike conventional unadjuvanted or aluminium-based adjuvanted vaccines. We have already demonstrated in pre-clinical models that a single dose of this vaccine candidate induces strong and rapid functional antibody responses including high serum bactericidal antibody titres. The next step of the development plan is thus to progress this promising vaccine candidate into a phase I clinical trial.

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Researchers

Adrian Hill (Co-Investigator)Andrew Pollard (Principal Investigator)Christine Rollier (Co-Investigator)David Wyllie (Co-Investigator)Martin Maiden (Co-Investigator)

Related Research

Grants with similar aims, by meaning.

Development of a PorA/FetA meningococcal vaccine for broad protection against meningococcal disease: progression from pre-clinical studies to Phase I clinical trials in humans.
Development of a Universal Meningococcal Vaccine
Development of a cost-effective protein-based combined glycoconjugate meningococcal-pneumococcal vaccine
Characterisation of meningococcal carriage isolates from UK MenCar4 study
MenSynVac Study

Original classification

Research Grant

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