Gonococcal immunoassays and standards stakeholder consultation workshop

Summary 

Gonorrhoea is a sexually transmitted disease that disproportionately affects women in low- and middle-income countries and threatens to become resistant to all available antibiotics. Globally, there are over 82 million episodes of gonorrhoea a year and the UK has recently recorded its highest level ever of confirmed gonorrhoea cases. An effective vaccine would be of enormous global public health benefit and have a major impact on the silent pandemic of antimicrobial resistance. Although no vaccine against gonorrhoea is currently available, several promising candidate vaccines are in development and about to enter clinical trials. Alongside vaccine development, it is essential to have robust assays that can accurately and effectively measure the immune response induced in humans by these vaccines. Such assays will ultimately be necessary for the licensing of gonococcal vaccines, but it takes many years to develop an internationally accepted assay, and this often involves the creation of a standard serum which can be used to ensure results are comparable between different laboratories.

This project will prepare and convene a workshop which brings together key stakeholders from high-, middle- and low-income countries in the field of gonococcal vaccine and assay development, along with regulators, policymakers, and funders. The meeting will set a pathway forward for the development of such an assay and the preparation of an international standard serum which will be suitable for acceptance and endorsement by the World Health Organisation. Findings and recommendations will be compiled in a report for publication and public dissemination.