Background

MenB-FHbp vaccine (Trumenba^®; bivalent rLP2086; Pfizer Inc, Philadelphia, PA) is licensed to prevent meningococcal serogroup B disease in Europe (≥10 years) and the United States (10-25 years). A MenABCWY vaccine containing MenB-FHbp is being developed.

Aims

Assess immunogenicity against serogroup B and safety of MenB-FHbp (2-dose schedule) and MenABCWY.

Methods

Participants (10-25 years) received MenB-FHbp (months 0,6) and MenACWY-CRM (month 0) or MenABCWY (months 0,6). Endpoints included percentages of participants achieving ≥4-fold increase from baseline in serum bactericidal assay using human complement (hSBA) titers for 4 primary serogroup B test strains and titers ≥lower limit of quantitation (LLOQ; 1:8 or 1:16) for primary strains combined (composite response) after dose 2 of MenB-FHbp or MenABCWY; a titer ≥1:4 is the accepted correlate of protection. Safety was assessed.

Results

Percentage of participants (n=814-850) achieving ≥4-fold increases in hSBA titers against primary strains after MenB-FHbp dose 2 ranged from 67.4%-95.0%; composite response was 74.3% (Figure 1). After MenABCWY dose 2, percentage of participants (n=418-432) achieving ≥4-fold increases in hSBA titers ranged from 75.8%-94.7%; composite response was 79.9% (Figure 2). For MenB-FHbp, most reactogenicity events were mild-to-moderate in severity. Adverse events (AEs), serious AEs, medically attended AEs, and newly diagnosed chronic medical conditions were reported by 40.7%, 0.8%, 26.7%, and 0.8% of participants, respectively. Safety and tolerability of MenABCWY was similar to MenB-FHbp.

Conclusions

MenB-FHbp at 0,6 months was well-tolerated and induced protective bactericidal antibody responses, supporting the 2-dose MenB-FHbp schedule. Results also support continued evaluation of MenABCWY .

Trial Registration: ClinicalTrials.gov: NCT03135834.