Gonococcal Vaccine Preferred Product Characteristics and Public Health Value Proposition: Initial Global Stakeholder Consultation

Summary

Gonorrhoea, a sexually transmitted infection (STI) caused by the bacterium Neisseria gonorrhoeae, is a major public health concern, with adverse consequences including pelvic inflammatory disease, infertility, and adverse pregnancy outcomes. Development of a vaccine for gonorrhoea has become a global public health priority, because the organism has developed resistance to currently available antibiotics. Recent scientific developments suggest a vaccine is biologically feasible, which has reinvigorated the field. However, several barriers remain. For example, there is a lack of consensus on the best approach to develop the vaccine (how it should work), the most effective use case (who should be immunized), what the vaccine should achieve (safety and efficacy requirements), and how it should be implemented within current immunization programmes, to have the greatest public health benefit. It will be especially important to understand these factors from the perspectives of low- and middle-income countries (LMICs), where the need for the vaccine may be greatest. We propose a global stakeholder consultation meeting to bring together experts in gonorrhoea basic science, epidemiology, public health control programs, and policy, particularly from LMICs, along with experts in vaccine development and industry partners.

The objectives of the meeting are to define where and for whom gonorrhoea vaccines are needed, discuss the characteristics a gonorrhoea vaccine should have to address the public health need, especially for LMICs, assess the status of current gonorrhoea vaccine development approaches, and determine how the vaccine would be delivered if available. Crucially, the meeting will identify critical research and data needs to advance gonorrhoea vaccine development. The consultation will result in one or more published scientific articles summarizing discussions from the meeting that provide guiding principles and preferences for gonorrhoea vaccines to meet priority public health needs, as well as gaps that need to be addressed to advance these vaccines.

Project outcomes

Interest in developing vaccines against Neisseria gonorrhoeae has grown dramatically in recent years, because of the rising threat of gonococcal anti-microbial resistance (AMR) and renewed optimism that vaccines for gonorrhoea are biologically feasible, given evidence for possible cross-protection against gonorrhoea by group B Neisseria meningitidis vaccines. Vaccine candidates using several approaches are currently in preclinical development. To stimulate investment and accelerate development of gonococcal vaccines, several questions need to be answered, including how future gonorrhoea vaccines would be received and used, and what their overall value would be in addressing public health goals in both low- and middle-income and high-income contexts. 

In January 2019, WHO convened a multidisciplinary international group of experts to lay the groundwork for understanding the potential public health value of gonorrhoea vaccines and for developing gonococcal vaccine preferred product characteristics (PPCs). WHO PPCs describe preferences for vaccine attributes that would be most relevant to the global unmet public health need. Meeting participants emphasized the need for vaccines to control gonorrhoea with the overarching public health goals of preventing adverse sexual and reproductive health outcomes such as infertility and reducing the impact of gonococcal AMR, which could dramatically worsen these outcomes. Meeting discussions centred around important PPC considerations like vaccine indications, target populations, and potential immunization strategies, and highlighted critical research and data needs to inform the public health value assessment and advance gonococcal vaccine development. 

Discussions from the BactiVac-supported WHO meeting are  reported in two manuscripts, which also include a summary of current gonococcal vaccine research and development efforts and a table of research and data needs that are essential for answering key questions about the use and value of gonorrhoea vaccines. The meeting discussions are the starting point for a planned collaborative, consultative process, led by WHO, to develop formal PPC documents and undertake activities to inform the public health value of gonococcal vaccines.