UK vaccine body recommends meningitis B vaccine for gonorrhoea prevention

The UK’s Joint Committee for Vaccination and Immunisation (JCVI) has recommended that people in the United Kingdom at increased risk of contracting gonorrhoea should be offered the 4CMenB vaccine (Bexsero) to reduce their risk.

The JCVI recommendation must be reviewed by the Department of Health and Social Care before the vaccine can be offered through sexual health clinics. Devolved health departments in Scotland and Northern Ireland usually follow JCVI recommendations.

The JCVI says that although gay and bisexual men should be the primary targets for a vaccine offer, others judged at increased risk of contracting gonorrhoea should also be eligible for the vaccine.

For everyone, ‘increased risk’ is defined as a recent history of gonorrhoea or another bacterial sexually transmitted infection, a new gonorrhoea diagnosis or reporting high-risk sexual behaviours with multiple partners.

The JCVI’s decision is based on findings from observational studies in adolescents and young adults in New Zealand, Australia and the United States who received the 4CMenB vaccine to protect against meningitis B. The bacteria that cause meningitis B and gonorrhoea (Neisseria meningitidis and Neisseria gonorrhoeae) are closely related.

While acknowledging that results of randomised studies of 4CMenB for gonorrhoea prevention are awaited, the JCVI say the existing study data, together with a cost-effectiveness analysis carried out by the UK Health Security Agency and Imperial College London, provide sufficient evidence to go ahead with a vaccination scheme in the UK.

“Introducing a vaccination programme to prevent gonorrhoea in England would be a world first and should significantly help to reduce levels of gonorrhoea, which are currently at a record high,” said Professor Andrew Pollard, chair of the JCVI.

In 2022, 82,592 cases of gonorrhoea were diagnosed in England, the highest number of diagnoses since records began in 1918. New diagnoses increased by 50% in 2022 compared to 2021. Almost half of all gonorrhoea cases were diagnosed in gay and bisexual men in 2022.

What’s the evidence for using the 4CMenB vaccine to prevent gonorrhoea?

The first evidence that vaccination against meningitis B might protect against gonorrhoea came from New Zealand, where a national vaccination campaign in 2004 used a vaccine tailored to the strain of meningitis B causing an outbreak among young people. Gonorrhoea rates fell in those who received the vaccine and a case-control study showed that in the decade following the vaccination campaign, people who received the vaccine were 31% less likely to be diagnosed with gonorrhoea.

South Australia reported that its 4CMenB vaccination programme for meningitis B reduced the risk of gonorrhoea by 34% up to three years after vaccination but protection declined beyond this point. A study of young people in New York City and Philadelphia found that the meningitis B vaccine was 40% effective in preventing gonorrhoea while a case control study of gay and bisexual men with HIV in Italy showed a vaccine effectiveness of 42%. A matched cohort study of young people in southern California showed 46% vaccine effectiveness.

The accumulating evidence from observational studies led French researchers to design a randomised study to test whether the 4CMenB reduced the incidence of gonorrhoea in gay and bisexual men on PrEP and at high risk of bacterial STIs. Preliminary results from the study suggested that the vaccine halved the rate of gonorrhoea. The DOXYVAC study was stopped in September 2022 and participants were asked to come back to the clinic for a final check-up.

However, after looking at the results of the final check-ups, the French researchers could no longer be certain that their result was statistically significant and decided to reanalyse the study data. Final results from DOXYVAC are expected in 2024.

In Australia, the GoGoVAX study is testing 4CMenB for gonorrhoea prevention in gay and bisexual men and transgender people and will report results in 2025. Another randomised study of 4CMenB for gonorrhoea prevention is underway in the United States, Thailand and Africa. It is likely to report results in 2026.

The JCVI’s decision was influenced by a cost-effectiveness analysis which showed that even at the level of vaccine effectiveness observed in New Zealand (31%), providing the 4CMenB vaccine in sexual health clinics after a diagnosis of gonorrhoea would be cost-effective. It would avert up to 110,000 cases of gonorrhoea and save £7.9 million over 10 years, the study found.

The study also found that vaccinating those at risk, rather than just those diagnosed, would be the most cost-effective strategy.

The JCVI advice emphasises that the individual reduction in risk may be modest, and that the duration of protection provided by 4CMenB is uncertain.

“Vaccinated individuals could expect to have some reduction in their own risk of contracting gonorrhoea, however the main benefit of a vaccination programme is expected to be at a community level with a significant reduction in the number of cases overall,” it says.

Also, the advice only applies to the vaccine already approved in the UK for meningitis B prevention in adolescents and young people, 4CMenB (Bexsero). It does not apply to the MenB-FHbp (Trumenba) vaccine licensed as an additional option in the United States and European Union. Trumenba contains different proteins and its effectiveness against gonorrhoea infection is still being studied.

Routine vaccination for mpox recommended

The JCVI has also recommended that those at highest risk of mpox should be offered the MVA-BN vaccine to protect against mpox. A targeted offer of vaccination against mpox began in June 2022 after an outbreak in the UK was detected. Vaccination ended in the summer of 2023.

Modelling by the Health Security Agency and the University of Bristol concluded that any vaccination strategy would reduce outbreak size and duration and be cost saving. On the basis of the modelling, the JCVI has decided that a pre-emptive programme – vaccinating as many people at high risk as possible before another outbreak – is preferable.

The JCVI recommends that mpox vaccination should be offered through sexual health clinics to gay and bisexual men and transgender people at highest risk of exposure to mpox, including:

• a recent history of multiple partners
• participating in group sex
• attending sex-on-premises venues
• a proxy marker such as a bacterial STI within the last year.