Background
Meningococcal disease and gonorrhoea are caused by closely related bacteria (Neisseria meningitidis and Neisseria gonorrhoeae) sharing 80–90% genetic homology. The 4CMenB vaccine (Bexsero®), containing outer membrane vesicles and recombinant antigens (NHBA/NadA/fHBP), was developed to prevent meningococcal B (MenB) disease. Publicly funded 4CMenB programs have been implemented in South Australia since 2018. We evaluated vaccine effectiveness (VE) against MenB disease and gonococcal infection six to seven years post-implementation, using case-control and cohort study designs.
Methods
Gonococcal notifications (cases) and chlamydia notifications (controls) were linked to the Australian Immunisation Register. A time-to-infection analysis among gonococcal cases used multivariable Cox proportional hazards models. For MenB disease, 20 AIR controls were randomly selected to estimate VE. VE was calculated as (1 − odds ratio) ×100%.
Results
Seven years after program introduction, VE against MenB disease was 57.2% (95%CI: −39.9% to 86.9%; p=0.160) for three doses in children and 85.3% (95%CI: 48.0% to 95.9%; p=0.003) for two doses in adolescents. Among MenB cases in children eligible for MenB vaccination, 8 out of 23 cases (35%) occurred in Aboriginal children.
At six years, VE of the two-dose schedule against gonococcal infection in adolescents born between February 1999-January 2010 was 40.2% (95%CI: 33.7% to 46.1%; p<0.001). Evidence of waning was observed at five years post-vaccination (4.1%; 95% CI: −17.8% to 21.9%; p=0.690) compared with within five years (44.4%; 95%CI: 37.7% to 50.4%; p<0.001). VE against subsequent gonococcal infection was 32.9% (adjusted hazard ratio [aHR] 0.671; 95%CI: 0.513-0.878; p=0.004). Chlamydia co-infection was associated with increased risk of subsequent gonococcal infection (aHR 1.881; 95%CI: 1.445-2.449; p<0.001). There was no reduction in risk of a third episode observed (aHR 0.701; 95%CI: 0.442-1.110; p=0.130).
Conclusions
The 4CMenB program demonstrates sustained protection against MenB disease in adolescents at seven years post-implementation, although effectiveness in children against all IMD was not statistically significant. Aboriginal children were disproportionately affected. Genomic studies will assess strain–vaccine match, and ongoing evaluation is warranted to determine whether booster strategies are required in high-risk groups. Moderate protection against gonococcal infection was observed in the adolescent/young adult population, with evidence of waning five years post-vaccination.