Randomised trials of meningococcal B (4CMenB) vaccination for the prevention of gonorrhoea

Objectives Neisseria gonorrhoeae is one of the most commonly reported sexually transmitted infections globally. Observational studies have suggested that vaccination with the four-component meningococcal serogroup B vaccine (4CMenB) is associated with a reduced risk of gonorrhoea, and several randomised controlled trials (RCTs) have subsequently been conducted. We performed a meta-analysis of trials to evaluate the efficacy of 4CMenB against gonorrhoea acquisition in men who have sex with men (MSM). Methods Four published RCTs of 4CMenB for prevention of gonorrhoea in MSM (ANRS 174 DOXYVAC, MenGo, GoGoVax and a trial from Hong Kong) were included. Numbers of first-episode gonorrhoea events and person-years of follow-up were extracted by study arms and analysed using a random-effects meta-analysis. Meta-incidence rate ratios (IRRs) and measures of heterogeneity were calculated. Results Four RCTs involving 1397 MSM reported 285 gonorrhoea episodes over 631.5 person-years in vaccinated participants and 306 episodes over 609.2 person-years in controls. None of the trials demonstrated a significant reduction in gonorrhoea incidence with vaccination. The meta-estimate showed no significant protective effect of 4CMenB against gonorrhoea acquisition (Meta-IRR 0.88, 95% CI 0.74 to 1.05), with low between-study heterogeneity (I2=6.8%). Conclusions Current evidence from RCTs does not support a significant effect of 4CMenB vaccination in preventing gonorrhoea among high-risk MSM.