Clinical Scorecard: Reassessing the Role of Meningococcal B Vaccination in Preventing Gonorrhoea Among Men Who Have Sex with Men

At a Glance

Key highlights

• WHO estimated that 82.4 million new gonorrhea cases occurred worldwide in 2020.

• Retrospective population-based studies reported approximately 30% protection from meningococcal B vaccination against gonorrhea.

• Four randomized clinical trials involving MSM did not demonstrate statistically significant protection from 4CMenB against gonorrhea.

• The relatively small clinical trials may have lacked sufficient power to determine vaccine efficacy.

• Vaccinated MSM might mistakenly believe they are protected against gonorrhea and reduce other precautions.

Authors’ recommendations

Diagnosis

• The editorial provides no specific diagnostic recommendations.

Management

• The authors argue that national and international scientific organizations should revisit the strategy and consider no longer recommending meningococcal B vaccination to protect MSM against gonorrhea.

Monitoring and follow-up

• The editorial provides no specific monitoring or follow-up recommendations.

Risks

• Vaccination may create a false sense of security if MSM mistakenly assume they are protected against gonorrhea.

• The authors suggest that 4CMenB may have little effect on preventing transmission while potentially attenuating symptoms, bacterial burden, or other clinical manifestations.

Population and vaccination data

The randomized trials enrolled MSM with known infection risks. In contrast, retrospective observational studies included adolescents and young adults from the general population with absent or unknown sexually transmitted infection risks.

The authors suggest that 4CMenB may have little effect on preventing gonorrhea transmission but could potentially reduce symptoms, bacterial burden, or other clinical manifestations.

Clinical considerations

• Routine clinical and surveillance data used in retrospective studies may have missed asymptomatic infections, particularly at extragenital sites.

• Asymptomatic breakthrough rectal gonorrhea has been reported after 4CMenB vaccination.

• Previous gonococcal infection among some trial participants might have produced immune responses that interfered with vaccine response.

• Other randomized trials involving women and populations at lower risk of gonorrhea were ongoing, with results expected within a year of the editorial’s publication.

Related resources and content

• WHO global STI estimates: Global and regional estimates of gonorrhea incidence.

• WHO Bacterial Priority Pathogens List 2024: Prioritization of Neisseria gonorrhoeae to guide antimicrobial resistance research, development, and public health strategies.

• Retrospective evidence: Population-based studies from the US, New Zealand, and Australia evaluating meningococcal B vaccination and protection against gonorrhea.

• Systematic review and meta-analysis: Evaluation of potential cross-protection from meningococcal vaccines against gonorrhea.

• DOXYVAC trial: French randomized trial evaluating 4CMenB among MSM at increased risk of infection.

• MenGO trial: Australian randomized trial evaluating 4CMenB among gay and bisexual men.

• GoGoVax trial: Australian placebo-controlled trial involving MSM receiving HIV preexposure prophylaxis or living with HIV.

• Hong Kong randomized trial: Placebo-controlled evaluation of 4CMenB among MSM at increased risk of gonorrhea.

• Vaccination programs: Published discussions of meningococcal B vaccination programs for gonorrhea prevention in England and Galicia, Spain.

• Breakthrough infection report: Microbiologic and clinical findings from breakthrough rectal gonorrhea infections after meningococcal B vaccination.