Meningococcal surrogates of protection?serum bactericidal antibody activity

Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo®) or Menactra® among healthy adolescents

“…Assays using rabbit complement (rSBA) are also used and have been the basis for licensure of several meningococcal vaccines. 9 A blinded analysis by hSBA was performed by Novartis Vaccines serology laboratory in Marburg, Germany, using methods as previously described. 6 Sera from 100 participants included in the per-protocol analysis from each of the active groups and 50 from the control group were randomly selected to undergo further testing with rSBA, which was performed by the Vaccine Evaluation Unit of the Health Protection Agency, Manchester Royal Infirmary, UK (Dr. Ray Borrow), as previously described.…”

Persistence of the immune response after MenACWY-CRM vaccination and response to a booster dose, in adolescents, children and infants

“…Several types of serological assays have historically been used for assessment of meningococcal antigen-specific immunity, including assays that measure complement-mediated bacterial killing using endogenous and exogenous complement (rabbit or human), anti-capsular antibody levels, or opsonophagocytosis, 35 and assays using different animal protection models. [36][37][38] Although the hSBA assay is the most commonly used serologic marker of protection, this assay is difficult to standardize due to the nature of the reagents used. [39][40][41] The bactericidal assay using complement derived from baby rabbit serum (rSBA) is a widely accepted alternative to the hSBA.…”

Oral administration of recombinantNeisseria meningitidisPorA genetically fused toH. pyloriHpaA antigen increases antibody levels in mouse serum, suggesting that PorA behaves as a putative adjuvant

“…Furthermore, the predominance of IgG 1 indicates that a cellular response induced by PorA stimulates an isotype switch to IgG 1 production, a common bactericidal isotype. 65 This finding is compelling because rPorA is capable of inducing a systemic Th2 response following oral immunization.…”