SUMMARY Neisseria gonorrhoeae infection is an important public health issue, with an annual global incidence of 87 million. N. gonorrhoeae infection causes significant morbidity and can have serious long-term impacts on reproductive and neonatal health and may rarely cause life-threatening disease. Global rates of N. gonorrhoeae infection have increased over the past 20 years. Importantly, rates of antimicrobial resistance to key antimicrobials also continue to increase, with the United States Centers for Disease Control and Prevention identifying drug-resistant N. gonorrhoeae as an urgent threat to public health. This review summarizes the current evidence for N. gonorrhoeae vaccines, including historical clinical trials, key N. gonorrhoeae vaccine preclinical studies, and studies of the impact of Neisseria meningitidis vaccines on N. gonorrhoeae infection. A comprehensive survey of potential vaccine antigens, including those identified through traditional vaccine immunogenicity approaches, as well as those identified using more contemporary reverse vaccinology approaches, are also described. Finally, the potential epidemiological impacts of a N. gonorrhoeae vaccine and research priorities for further vaccine development are described.

Neisseria gonorrhoeae vaccines: a contemporary overview

The meningococcal group B vaccine, 4CMenB, is a broad-spectrum, recombinant protein vaccine that is licensed for protection against meningococcal group B disease in children and adults. Over the past decade, several observational studies supported by laboratory studies have reported protection by 4CMenB against gonorrhoea, a sexually transmitted infection caused by Neisseria gonorrhoeae. Gonorrhoea is a major global public health problem, with rising numbers of diagnoses and increasing resistance to multiple antibiotics. In England, more than 82 000 cases of gonorrhoea were diagnosed in 2022, with nearly half of the cases diagnosed among gay, bisexual, and other men who have sex with men. There are currently no licensed vaccines against gonorrhoea but 4CMenB is estimated to provide 33-47% protection against gonorrhoea. On Nov 10, 2023, the UK Joint Scientific Committee on Vaccination and Immunisation agreed that a targeted programme should be initiated using 4CMenB to prevent gonorrhoea among individuals at higher risk of infection attending sexual health services in the UK. This decision was made after reviewing evidence from retrospective and prospective observational studies, laboratory and clinical data, national surveillance reports, and health economic analyses. In this Review, we summarise the epidemiology of invasive meningococcal disease and gonorrhoea in England, the evidence supporting the use of 4CMenB for protection against gonorrhoea, and the data needed to inform long-term programme planning and extension to the wider population. 

Use of a meningococcal group B vaccine (4CMenB) in populations at high risk of gonorrhoea in the UK.

To systematically review and synthesis the evidence of vaccine effectiveness (VE) and impact (VI) of meningococcal vaccines in preventing gonorrhoea. 

Vaccine effectiveness and impact of meningococcal vaccines against gonococcal infections: A systematic review and meta-analysis

This review outlines recent trends on invasive meningococcal disease (IMD) discussed at the latest meeting of the Global Meningococcal Initiative (GMI). There has been a re-emergence of the Hajj strain sublineage (serogroup W; ST-11 clonal complex), with travel to the Kingdom of Saudi Arabia being a critical factor in transmission. The epidemiology of IMD has also changed following the COVID-19 pandemic, with annual IMD cases increasing in many countries. For example, the highest number of IMD cases since 2014 was reported in the USA in 2023-2024. Atypical presentations of IMD have been prominent irrespective of the pandemic. For instance, an increase in cases of meningococcal epiglottitis has been reported in France in 2022-2023 (serogroups W and Y). When considering vaccination, the GMI has identified a need for broader meningococcal serogroup B (MenB) immunisation owing to the potential impact of the vaccines on reducing IMD incidence caused by other serogroups than MenB. There is also a case for using MenB vaccination to protect against Neisseria gonorrhoeae infection based on initial evidence, albeit further studies will need to be conducted. 

Current global trends in meningococcal disease control, risk groups and vaccination: Consensus of the Global Meningococcal Initiative

Abstract Background 4CMenB appears to be effective in reducing Neisseria gonorrhoeae (Ng) infections. Aims are to assess factors associated with breakthrough rectal Ng after 4CMenB and evaluate clinical and microbiological characteristics of breakthrough infections compared with before vaccination. Methods This was a retrospective study of gay, bisexual, and other men who have sex with men (GBMSM) vaccinated with 4CMenB (2 doses) between 2017 and 2023 at the San Raffaele Scientific Institute for Research, Hospitalization and Healthcare (IRCCS San Raffaele Scientific Institute), Milan, Italy, and tested for rectal Ng. Rectal Ng infection is considered breakthrough if it occurs &amp;gt;1 month after the second 4CMenB dose and with positive nucleic acid amplification test (NAAT) result. Follow-up was from July 2017 (first 4CMenB vaccination) to November 2023 (data freeze). Rectal Ng was screened with both NAAT and gonococcal-specific cultures. Characteristics of individuals with or without breakthrough Ng and of Ng infections before or after 4CMenB were compared using Mann-Whitney and χ2/Fisher tests. Results Overall, 473 GBMSM vaccinated with 4CMenB were included, with a median age (interquartile range) of 43 (37–51) years; 451 of 473 were living with human immunodeficiency virus. The percentage of NAAT-positive rectal Ng swab samples was 76 of 957 (7.7%) after 4CMenB and 51 of 456 (11.1%) before. Breakthrough rectal Ng after baseline were 76 in 57 of 473 people. People with rectal Ng after 4CMenB were younger, more likely to have a previous sexually transmitted infection, and had more sexual partners than those without (all P &amp;lt; .001). Breakthrough rectal Ng infections were less frequently symptomatic (34.2% vs 66.7%; P = .001) and more likely with negative gonococcal-specific culture (55.3% vs 19.6%; P &amp;lt; .001) compared with before vaccination. Conclusions Breakthrough rectal Ng infections after 4CMenB were 76 in 57/473 people, preferentially identified in GBMSM with higher-risk sexual behaviors, were less often symptomatic, and more often with negative gonococcal-specific cultures, suggesting lower infection virulence. 

Breakthrough Rectal Neisseria gonorrhoeae Infections After Meningococcal B Vaccination: Microbiological and Clinical Features

Healthy vaccinee bias likely did not confound earlier studies demonstrating the protective effect of outer-membrane vesicle serogroup B meningococcal vaccines against gonorrhea. Abstract Observational studies demonstrated 30% to 40% effectiveness of outer-membrane vesicle (OMV) meningococcal serogroup B vaccines against gonorrhea. To explore whether healthy vaccinee bias influenced such findings, we examined the effectiveness of MenB-FHbp, a non-OMV vaccine that is not protective against gonorrhea. MenB-FHbp was ineffective against gonorrhea. Healthy vaccinee bias likely did not confound earlier studies of OMV vaccines.

Healthy Vaccinee Bias and MenB-FHbp Vaccine Effectiveness Against Gonorrhea

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Healthy Vaccinee Bias and MenB-FHbp Vaccine Effectiveness Against Gonorrhea