A Phase 2, Randomized, Active-controlled, Observer-blinded Study to Assess the Immunogenicity, Tolerability, and Safety of Bivalent rLP2086, a Meningococcal Serogroup B Vaccine, Coadministered With Tetanus, Diphtheria and Acellular Pertussis Vaccine and Serogroup A, C, Y and W-135 Meningococcal Conjugate Vaccine in Healthy US Adolescents.

Bivalent rLP2086, targeting meningococcal serogroup B (MnB), will extend prevention of meningococcal disease beyond that provided by quadrivalent serogroup ACWY-vaccines; coadministration with recommended vaccines may improve adherence to vaccine schedules. This phase 2, randomized, active-controlled, observer-blinded study assessed whether immune responses induced by coadministration of Menactra (meningococcal A, C, Y, and W-135 polysaccharide conjugate vaccine [MCV4]) and Adacel (tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine [Tdap]) with bivalent rLP2086 (Trumenba [MnB vaccine], approved in the United States) were noninferior to MCV4+Tdap or bivalent rLP2086 alone.
Healthy adolescents aged 10-<13 years received MCV4+Tdap+bivalent rLP2086, MCV4+Tdap, or bivalent rLP2086. Bivalent rLP2086 response was assessed with serum bactericidal assays using human complement (hSBAs) with 2 MnB test strains expressing vaccine-heterologous factor H binding protein variants; MCV4 with SBAs using rabbit complement; and Tdap with multiplexed Luminex assays. Safety was evaluated.
2648 subjects were randomized. Immune responses to MCV4+Tdap+bivalent rLP2086 were noninferior to MCV4+Tdap or bivalent rLP2086 alone. Seroprotective hSBA titers were documented for 62.3%-68.0% and 87.5%-90% of MCV4+Tdap+bivalent rLP2086 recipients after doses 2 and 3, respectively. A ≥4-fold rise in hSBA titers from baseline was achieved by 56.3%-64.3% and 84.0%-85.7% of subjects after doses 2 and 3, respectively. Bivalent rLP2086 alone induced similar responses. Concomitant administration did not substantially increase reactogenicity compared with bivalent rLP2086 alone.
Bivalent rLP2086 given concomitantly with MCV4+Tdap met all noninferiority immunogenicity criteria without a clinically meaningful increase in reactogenicity. MCV4 and bivalent rLP2086 coadministration would provide coverage against the 5 major disease-causing serogroups.

Authors:Muse D1, Christensen S, Bhuyan P, Absalon J, Eiden JJ, Jones TR, York LJ, Jansen KU, O'Neill RE, Harris SL, Perez JL.
Journal:Pediatr Infect Dis J. 2016