Guidance

Surveillance of targeted 4CMenB vaccination to protect individuals at higher risk of gonorrhoea

Published 13 November 2025

Applies to England

Summary of revisions

Version number	Change details	Date
1.0	First published	November 2025

1. Background

This surveillance plan sets out the national monitoring and analysis intended to support the targeted 4CMenB vaccination to protect individuals at higher risk of gonorrhoea infection in England. This is for transparency and the information may be of interest to clinical staff and others delivering the programme, laboratory staff, UK Health Security Agency (UKHSA) Health Protection Teams and countries considering a similar targeted vaccination programme.

The UKHSA Immunisation and vaccine preventable disease and Blood Safety, Hepatitis, STI and HIV Divisions and Meningococcal Reference Unit have compiled the plan with contributions from; Shazaad Ahmad, Nick Andrews, Ray Borrow, Helen Campbell, Marta Checchi, Stephen Clark, Helen Fifer, Emma Heymer, Shamez Ladhani, Jay Lucidarme, Hamish Mohammed, Sonia Ribeiro, John Saunders, Katy Sinka, Kate Soldan, Laura Viviani.

2. Surveillance objectives

This national surveillance plan describes the monitoring and associated epidemiological analyses to inform and evaluate the targeted programme using 4CMenB vaccination for the prevention of gonorrhoea in those at greatest risk of infection, as advised by the Joint Committee on Vaccination and Immunisation (JCVI) (JCVI advice on the use of meningococcal B vaccination for the prevention of gonorrhoea).

The 4CMenB gonococcal vaccination programme primarily targets gay, bisexual and other men who have sex with men (GBMSM) who are at increased risk of gonorrhoea. Thus, this surveillance plan focuses on gonorrhoea in GBMSM at higher risk of infection. Whilst no other group has a gonorrhoea incidence approaching that of the eligible GBMSM cohort, clinicians have some discretion to offer 4CMenB to individuals with a gonorrhoea incidence similar to eligible GBMSM, such as a sex workers practicing condomless sex. Those vaccinated amongst these groups are likely to be small in number and, therefore, monitored separately outside this surveillance plan.

The surveillance objectives for the targeted GBMSM population programme are:

• to monitor the uptake of the 4CMenB vaccine and estimate vaccine coverage
• to evaluate the impact of the 4CMenB vaccination programme on gonorrhoea incidence
• to estimate the effectiveness of the 4CMenB vaccination programme against gonorrhoea infection using different methodological approaches
• to monitor any change in the characteristics of Neisseria gonorrhoeae strains

The Medicines and Healthcare Regulatory Agency (MHRA) safeguards medical products quality and efficacy in the United Kingdom including routine monitoring of vaccine safety. The Yellow Card scheme is run by the MHRA. Anyone, whether member of the public or health professional, can report an issue with a medicine, vaccine, medical device, blood product or e-cigarette to the Yellow Card scheme (1). The 4CMenB vaccine has been safely used in the infant vaccination programme in England since 2015 and in many other European countries. In the USA teenagers may get a MenB vaccine (2), including 4CMenB, whilst in Australia infants and children aged under 2 years, alongside adolescents, are recommended to complete 4CMenB vaccination (3).

The primary purpose of the 4CMenB vaccination programme targeting gonorrhoea in groups at high risk is to reduce gonorrhoea infections but the vaccine will also offer protection against invasive meningococcal disease (IMD) which, although serious, is rare in the UK. National surveillance is already in place for IMD cases and vaccine programmes targeting IMD. These will continue to monitor all cases of IMD including those in GBMSM eligible for 4CMenB (see Appendix).

3. The targeted 4CMenB programme vaccinating against gonorrhoea

Gonorrhoea is a bacterial sexually transmitted infection (STI). It is the second most diagnosed STI in England, and is transmitted through condomless vaginal, oral or anal sex. Gonorrhoea infection can cause pelvic inflammatory disease which can lead to infertility, and it can cause pain in the testicles and prostate (see Gonorrhoea - NHS). Antimicrobial resistance to all antibiotic classes used to treat gonorrhoea has been reported globally.

The government accepted the JCVI’s advice that the NHS should implement a routine opportunistic gonorrhoea vaccination programme (4) using the 4CMenB vaccine. Eligible people will be identified through sexual health services (SHS), based on markers of high risk of infection, including a recent history of multiple sexual partners or recent bacterial STI. This announcement followed a record high of 85,000 gonorrhoea diagnoses in England in 2023, which was 3 times higher than in 2012. There were 71,802 diagnoses in 2024, including approximately 39,000 in GBMSM (5). SHS started to offer the vaccine from 1 August 2025.

4CMenB is an existing vaccine licensed to protect against invasive meningococcal group B disease. People with invasive meningococcal disease (IMD) usually present with meningitis (inflammation of the membrane that surrounds the brain and spinal cord) and/or septicaemia (blood poisoning), both of which are serious life-threatening conditions. Although the diseases are very different, the bacteria that cause IMD (Neisseria meningitidis) and gonorrhoea (Neisseria gonorrhoeae) are closely related, sharing about 80 to 90% of their genes and with some common proteins on their surface.

There are currently no licensed vaccines against gonorrhoea but, as the meningococcal and gonococcal bacteria are so similar, the 4CMenB vaccine can offer some protection against both infections. From different studies around the world, including South Australia where the 4CMenB vaccine is routinely offered to teenagers, it is estimated that 2 doses of 4CMenB vaccine could provide up to 20 to 40% protection against gonorrhoea for up to 4 years after vaccination (6). Preventing gonorrhoea infections has the added benefit of reducing healthcare utilisation, STI investigations and antibiotic treatments, which could help tackle the increasing global burden of antibiotic use and antimicrobial resistance (7).

4. Gonorrhoea surveillance in England

Testing and diagnosis of gonorrhoea in England are monitored using the GUMCAD STI Surveillance System (8), (9). GUMCAD is a mandatory reporting system that collects records of each consultation, test and diagnosis at all local authority-commissioned SHS in England. These data have been submitted to GUMCAD on a quarterly basis since 2008 by over 200 sexual health services (10). Data on gonorrhoea diagnoses in England are published as quarterly provisional data, and annually in the UKHSA’s STI Official Statistics Sexually transmitted infections (STIs): annual data. GUMCAD is a pseudonymised patient-level database that does not collect direct identifiers such as name or date of birth; patient identification codes used by the clinic can, therefore, be used to link attendances and codes for testing and diagnoses for the same service user within a clinic but cannot be used to link this information across clinics or other health care services.

Clinicians do a risk assessment at most, if not all, SHS visits. A history of a bacterial STI in the previous 12 months is used as a proxy measure of being at high risk of gonorrhoea using GUMCAD data, and the reported number of partners in the last 3 months (where this is reported) can also be used as a marker of being at higher risk, these records can therefore help identify those eligible for 4CMenB vaccination for the prevention of gonorrhoea. In some cases, factors informing clinical decisions on eligibility may not be recorded in GUMCAD.

5. Monitoring of antimicrobial resistance (AMR) in gonorrhoea

The Gonococcal Resistance to Antimicrobials Surveillance Programme (GRASP) is a national sentinel surveillance system established in 2000, that collects approximately 1,500 N. gonorrhoeae isolates from individuals attending a network of 27 SHS across England and Wales (between August and September, inclusive, annually). GRASP objectives include characterising annual antimicrobial susceptibility patterns in N. gonorrhoeae, monitoring trends over time, identifying associations between antimicrobial resistant gonococci and patient demographics, clinical and behavioural data, and applying molecular typing and characterisation to further investigate any emerging resistance trends. GRASP surveillance informs the development of national gonorrhoea treatment guidelines. The data are published annually in the Gonococcal resistance to antimicrobials surveillance programme report.

Additionally, all primary microbiology laboratories in England are requested to refer any N. gonorrhoeae isolates with ceftriaxone resistance to the national Sexually Transmitted Infections Reference Laboratory (STIRL), for confirmation and follow up. SHS report any ceftriaxone treatment failures to UKHSA through the HIV STI Data exchange (accessible to registered users).

6. Patient information

The UKHSA performs surveillance of sexually transmitted infections (STIs) such as gonorrhoea for health protection purposes under permissions granted to UKHSA to collect and process pseudonymised GUMCAD patient data under Regulation 3 of The Health Service (Control of Patient Information) Regulations 2020 and Section 251 of the National Health Service Act 2006.

7. Monitoring the 4CMenB programme targeting gonorrhoea

7.1. Measurement of vaccine uptake and estimates of vaccine coverage

Recorded 4CMenB vaccine doses administered to eligible SHS attenders will be reported using the GUMCAD STI Surveillance System, and coverage estimated. 4CMenB vaccination uptake is recorded using Sexual Health and HIV Activity Property Type (SHHAPT) codes MBVD1 and MBVD2, for first and second doses, respectively. Additionally, MBVD0 also documents if vaccination was offered and declined and MBVDX records if the vaccination course has already been completed at another SHS. Vaccination uptake of one and 2 doses will be estimated in specialist SHS among attendees eligible for the 4CMenB vaccine.

Accurate recording of 4CMenB vaccine offer and decline, first and second dose administered are key to reliable monitoring of doses administered, and for estimating vaccine coverage and vaccine effectiveness (VE), especially given the modest protection expected. Service evaluation of the recording of vaccine offer and status of individuals eligible for 4CMenB on GUMCAD may be undertaken to better inform understanding of any data limitations.

7.2. Impact of 4CMenB vaccine on gonorrhoea diagnoses

The analysis will focus on direct effects of the 4CMenB vaccine programme on the numbers and/ or rates of gonorrhoea diagnoses in GBMSM starting from quarter 4 (October to December) 2025, with a comparator period from Q1 2022 to Q2 2025 and a transition period of Q3 2025 when the vaccine programme will first start to be rolled out. Depending on review of existing surveillance data, denominators may be considered relatively stable over this period (and, therefore, comparison could be based on number of diagnoses) or rates may be estimated using denominators for each ‘eligibility category’ group as numbers of high risk GBMSM (eligible, defined using GUMCAD records as set out in Section 3 Gonorrhoea surveillance in England, non-high risk GBMSM (not eligible), non-GBMSM males (not eligible) or females (not eligible) accessing sexual health services, derived from GUMCAD records in a period prior to a particular date (for example, start of each quarter or start of July each year). If necessary, the analysis can adjust for changes in denominator each year. Confirmed cases of gonorrhoea and chlamydia identified in GUMCAD by quarter will be reviewed to determine their ‘eligibility category’ as: eligible GBMSM, non-eligible GBMSM, non-GBMSM males or females.

Trends in gonorrhoea diagnoses observed in GBMSM at high risk of infection pre-vaccine rollout (Q1 2022 to Q2 2025) could then be extrapolated to a post vaccine period to generate expected numbers in the absence of vaccination. This can be compared to observed cases of gonorrhoea starting from Q3 2025. Chlamydia rates in the 4CMenB vaccine eligible group could also be compared over the same period as this is the second most commonly diagnosed STI in GBMSM and disease trends through time tend to be similar. These trends will be assessed overall and within age groups. The recent publication of the 2025 UK guideline for the use of doxycycline post-exposure prophylaxis (doxyPEP) for the prevention of syphilis (11) alongside the documented effectiveness of doxyPEP against chlamydia infection will need to be considered in the analysis. Rates of other STIs will also be considered as potential comparator groups.

An alternative to trend extrapolation is to compare rate changes pre-post vaccine roll out in the eligible group with non-eligible groups (women, non-eligible GBMSM and non-GBMSM). This does rely on the assumption trends would otherwise be similar in these groups, so assessment of the pre-vaccine period will be used to check this, including by age (for example, a big fall in gonorrhoea cases has been observed in the 15 to 24 year age group in 2024). If trends pre-vaccine introduction by quarter are not similar enough the method will not be used.

Analysis will be done by negative binomial regression with factors for time, vaccine eligibility and where applicable an offset for population. Impact will be measured as one minus incidence rate ratio. Impact will be interpreted alongside estimates of vaccine uptake.

7.3. Effectiveness of 4CMenB vaccine against gonorrhoea

Different methods for estimating vaccine effectiveness will be used, as each may have limitations due to likely data incompleteness leading to measurement errors in vaccination status alongside possible biases in who amongst the eligible group receives this vaccine. Vaccine effectiveness may, therefore, be estimated using a cohort or nested case-control design. For a cohort analysis individuals would become part of the cohort when they first visit SHSs from 1 July 2025 and are identified at that time as GBMSM at high risk of infection. Each individual in this vaccine eligible (with eligibility defined using GUMCAD records as set out in Section 3 Gonorrhoea surveillance in England) cohort is followed up from their first SHS visit on or after 1 July 2025 for receipt of 4CMenB dose 1 and 4CMenB dose 2, or refusal, until the individual is diagnosed with gonorrhoea or the date of the last visit prior to within the analysis period. Additional analyses will also include repeat episodes if separated by at least 42 days (the standard interval used in GUMCAD to identify separate episodes of gonorrhoea), in this case person time will not end when a diagnosis occurs.

To be included, an individual would need to be classified as a regular attender at a specific clinic in a period prior to vaccine rollout to ensure continuity of recording and capture of vaccine status. This is to minimise the likelihood of including GBMSM who may be vaccinated at one SHS but diagnosed in another SHS, as these records can’t be linked so this could lead to underestimation of incidence. If an eligible individual is positive for gonorrhoea at their first visit, then this episode will not be included in the VE analysis as follow-up time will start 2 weeks after the first visit. Cohort analysis would be undertaken using Poisson regression or survival analysis, with vaccination as a time varying covariant (none to one to 2 doses assuming immunity is acquired from day 14 after vaccination). Covariates would be as ascertained at first visit or for the whole cohort at 1 July and may include, for example, total STIs in previous year, number of partners (this is reported by most, though not all, high throughput GBMSM SHS), doxyPEP use, HIV/PrEP status, region of residence, age, ethnicity, residential area-level index of multiple deprivation, country/ region of birth alongside adjustment for past STI testing frequency. It is recognised that there may be delays in vaccine coding being adopted and recorded by clinics which may be an issue if more vaccine is administered early in the programme rollout. Updating status on covariates at annual intervals, for example, may be appropriate if the surveillance continues over several years.

A nested case-control study of GBMSM at high risk may also be done within the above cohort to allow closer matching and to ensure similar testing of the comparator group. Each case is matched to one or more controls on having had a routine STI test that is not gonorrhoea positive within a defined period (for example, 2 weeks) and matching on potential key confounders and adjusting for others. The 4CMenB vaccination status in the cases are then compared to those in the controls to generate an estimate of vaccine effectiveness. This analysis, as well as the cohort analysis, may be stratified by prior gonorrhoea diagnosis within a defined period (possibly a year) or if infected with gonorrhoea at the time of either vaccination. Analysis is by conditional logistic regression.

There are caveats for the above VE assessment measures because they are reliant/ affected by how well vaccine status is recorded in GUMCAD and also likely affected by movement of individuals between different SHSs. It is also difficult to control for those at higher risk being more likely accepting the vaccine than those at lower risk (leading to under estimation of VE) and self-selection or healthy vaccine effects (people who take up the offer of vaccination being potentially more likely also to adopt other preventive or healthy behaviours and be in better overall health than unvaccinated people, leading to an overestimation of VE). Assessment of a control condition such as using chlamydia as the outcome or as a control in the case-control study may help assessing these biases, although the potential impact of doxyPEP on both chlamydia and marginally on gonorrhoea, has already been noted and would need to be accounted for.

The extent of data incompleteness (measurement error) for vaccination status will be explored, if possible. Or it may be possible to undertake a service evaluation to look at the completeness of vaccination history recorded on GUMCAD with those in clinic records.

A final method to estimate VE would be to use population level data on impact and coverage to back-calculate the effectiveness consistent with these measures.

 8. Service Evaluation in participating clinics

We will conduct a rapid prospective observational evaluation of the programme by recruiting GBMSM eligible for vaccination who agree to get vaccinated and eligible GBMSM who decide not to have the vaccine in a small number of SHSs across England. We will evaluate the vaccine attitudes (perceived benefits and risks) and factors associated with vaccine uptake and declines using a short online questionnaire. We will also evaluate behavioural changes after vaccination, vaccine effectiveness, impact and duration of protection.

9. 4CMenB vaccination impact on the characteristics of gonococcal isolates

Since 2020, gonococcal isolates collected as part of GRASP (approximately 1,500 isolates per year) routinely undergo whole-genome sequencing. Comparison will be performed of the strain types of GRASP isolates from vaccinated and unvaccinated eligible and non-eligible individuals, and from before and after the 4CMenB gonorrhoea programme was started, to investigate changes in the gonococcal population.

10. Dissemination of information and outputs

Successful implementation of the national surveillance programme will continue to depend on collaboration of SHS and clinicians looking after patients with STIs to maintain high quality records and offer the vaccine to those eligible.

Reports to the Joint Committee on Vaccination and Immunisation (JCVI) will include disease incidence and vaccination coverage, vaccine effectiveness and programme impact when this becomes available. Data on impact and effectiveness will also be published in peer reviewed publications.

Appendix

1. Surveillance of invasive meningococcal disease (IMD)

Enhanced surveillance of IMD has been in place since the first meningococcal vaccine programme targeting group C (MenC) IMD was introduced from September 1999, following the increase of a hyperinvasive MenC strain that emerged and increased in the UK from the mid-1990s. The meningococcal enhanced surveillance plan was revised in August 2015 with the introduction of infant 4CMenB and teenage MenACWY vaccine programmes targeting meningococcal group B (MenB) and an emergent hyperinvasive strain of meningococcal group W (MenW) disease, respectively (12).

Guidance for public health management of IMD (13) highlights that all invasive meningococcal isolates should be referred to the national Meningococcal Reference Unit (MRU) for confirmation and characterisation, including serogrouping and antibiotic susceptibility testing. The MRU also offers a free service for meningococcal PCR on clinical samples from suspected IMD cases. If IMD is confirmed by a local diagnostic laboratory (including private laboratories), then the original sample, including extracts from PCRs, should be referred to the National Reference Laboratory to allow the capsular group to be confirmed or identified and for additional characterisation.

2. Surveillance of meningococci from urogenital or anorectal sites

Sporadic cases of meningococcal urogenital and anorectal infections have infrequently been reported, typically following orogenital contact with an oropharyngeal meningococcal carrier, and are clinically indistinguishable from gonorrhoea (14). However, in 2023 to 2024, sexual health clinicians in England reported an increase in meningococcal urogenital infections. This coincided with increases in MenY urogenital and anorectal infections reported in Australia due to the MenY ST-1466 strain. A large proportion of the Australian cases arose in GBMSM, female sex workers and their clients; although nearly half the cases were reported amongst men who have sex with women only (15). Cases of IMD belonging to the MenY ST-1466 strain have also increased recently in the USA (16). Similar outbreaks due to an unrelated non-groupable strain have also been reported in the USA.

Furthermore, for over a decade, a putatively sexually transmitted MenC strain has caused multiple outbreaks of IMD among MSM in Europe and the USA.

Following these recent concerns relating to meningococcal infection of the anorectal and urogenital tracts, laboratories were requested to refer all meningococcal isolates from anorectal and urogenital sites from SHSs to the UKHSA Meningococcal Reference Unit (MRU) in Manchester, England, for confirmation and further characterisation (see Meningococcal disease: guidance on public health management). Where meningococci are isolated from a symptomatic urogenital or anorectal infection, standard treatment for gonorrhoea or non-specific urethritis is expected to clear the meningococci. In asymptomatic individuals, treatment is not recommended because asymptomatic carriage is common. Additionally, there is no further public health management of contacts of individuals with symptomatic or asymptomatic urogenital or anorectal meningococcal infection.

3. National meningococcal surveillance data

Public health action following reports of suspected or confirmed cases of IMD to UKHSA Health Protection Teams continues according to national guidance (13) as does surveillance based on national data on laboratory-confirmed IMD cases. A reconciled database holding demographic, clinical, immunological and vaccine information, as appropriate, from the follow up of all cases confirmed by the UKHSA Meningococcal Reference Unit (MRU) in England will be maintained and is used to monitor any outbreaks that arise in individuals with sociodemographic links, including GBMSM.

References

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2. Meningococcal Vaccination, meningococcal. Centers for Disease Control and Prevention (CDC).

3. Meningococcal disease, the Australian Immunisation Handbook.

4. NHS England, Action needed for delivery of routine mpox and gonorrhoea vaccination programmes 2025.

5. Sexually transmitted infections (STIs): annual data. UK Health Security Agency.

6. Wang B, and others. 4CMenB Vaccine Effectiveness Against Gonococcal Infection at Four Years Post-Program Implementation: Observational Case-Control Study. Open Forum Infectious Diseases. 2024.

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9. H Mohammed, and others. Enhancing surveillance of sexually transmitted infections in England with gender identity and behavioural data: the GUMCAD STI Surveillance System, medRxiv.

10. GUMCAD STI Surveillance System guidance on the collection and reporting of data for. UK Health Security Agency.

11. Doxycycline post-exposure prophylaxis 2025 guidelines. British Association for Sexual Health and HIV.

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13. Meningococcal disease: guidance on public health management. UK Health Security Agency.

14. Ladhani SN, and others. Meningococcal disease and sexual transmission: urogenital and anorectal infections and invasive disease due to Neisseria meningitidis. Lancet. 2020.

15. Lahra MM and others. Investigation and response to an outbreak of Neisseria meningitidis serogroup Y ST-1466 urogenital infections, Australia. Communicable Diseases Intelligence. 2024.

16. CDC Health Alert Network. Increase in invasive serogroup Y meningococcal disease in the United States. 28 March 2024.