Four-year antibody persistence and response to a booster dose of a pentavalent MenABCWY vaccine administered to healthy adolescents and young adults

Abstract

This open-label, multicenter extension study (NCT02451514) assessed persistence of Neisseria meningitidis serogroups ABCWY antibodies 4 years after primary vaccination. Adolescents and young adults who previously received 2 doses of MenABCWY+OMV (Group III), 1 dose of MenACWY-CRM (Group VI), or newly-recruited vaccine-naïve participants (Group VII) were administered 1 (Group III) or 2 doses (Groups VI and VII) of MenABCWY+OMV, 1 month apart. Immunogenicity was assessed by human serum bactericidal assay (hSBA). Safety and reactogenicity were also evaluated. Percentages of participants with hSBA titers ≥8 (serogroups ACWY), ≥5 (serogroup B) and hSBA geometric mean titers (GMTs) were evaluated in all 129 enrolled participants (Group III: 33; Group VI: 46; Group VII: 50). Anti-ACWY antibody concentrations waned over 4 years post-vaccination, but remained above pre-vaccination concentrations. Similarly, levels of antibodies against serogroup B test strains also waned over 4 years post-vaccination, but remained above pre-vaccination concentrations for some strains. MenABCWY+OMV booster induced a robust anamnestic anti-ACWY response in Group III and VI and a good response against serogroup B test strains (≥82%) in Group III. In serogroup B-naïve participants (Groups VI and VII), anti-B responses to 2 doses of MenABCWY+OMV were less homogenous and lower than in Group III. MenABCWY+OMV was reactogenic, but well-tolerated. No safety concerns were identified. These findings indicate that although antibodies against N. meningitidis serogroups ABCWY waned over 4 years post-vaccination, exposure to a MenABCWY+OMV booster dose elicits an anamnestic response in adolescents previously exposed to the same or another multivalent meningococcal vaccine.

Vaccines against Meningococcal Diseases

“…Investigation of a next-generation, pentavalent combination MenABCWY-CRM-conjugated vaccine has been started in adolescents and adults [ 105 , 106 , 107 , 108 , 109 , 110 ]. This vaccine combines MenACWY-CRM and the 4CMenB vaccine and has been developed to provide broader protection against the five most epidemiologically relevant serogroups.…”

Translating meningococcal serogroup B vaccines for healthcare professionals

“…As MenB and MenACWY vaccines cover most disease-causing serogroups [5], guidelines that include concomitant administration of these two vaccines can help protect against the majority of meningococcal disease worldwide and would likely improve compliance by requiring fewer medical visits [172][173][174]. Alternatively, a single pentavalent MenABCWY vaccine, currently in development [175,176], could potentially simplify existing meningococcal vaccine recommendations and increase the convenience of vaccination to optimize the protection of those at risk [32,177].…”

“…A retrospective study from New Zealand examined whether MenB vaccination could be protective against diseases caused by other Neisseria species and found that individuals immunized with an OMV MenB vaccine were significantly less likely to be hospitalized due to N gonorrhoeae infection [107]. In addition, as noted above, pentavalent MenABCWY vaccines are currently in development, which should simultaneously protect individuals against the five common disease-causing serogroups [175,176]. Both MenB-4C and MenB-FHbp contain FHbp, which is found in most IMD strains across serogroups [15,16,91].…”

Antibody persistence following meningococcal ACWY conjugate vaccine licensed in the European Union by age group and vaccine

“…MenA, W, and Y hSBA titers ≥4 were ≥41% (95% [CI]: [34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49] and ≥37% (95% CI 24-51) in the MenACWY-TT and MenC-CRM 197 groups, respectively. One-month post-booster with the ACWY-TT vaccine, rSBA GMT against the four serogroups increased ≥42-fold.…”

“…Antibody persistence has been demonstrated following the currently licensed meningococcal ACWY conjugate vaccines though new quadrivalent vaccines that are undergoing development will be licensed in the future [48]. A further development is likely to see new meningococcal vaccines where the serogroup B protein-based vaccines are incorporated into the quadrivalent ACWY conjugates yielding pentavalent ABCWY vaccines [49].…”