723a. A Booster Response to an Investigational Meningococcal MenABCWY Vaccine in Adolescents Previously Vaccinated with MenACWY, 4CMenB or MenABCWY: a Phase 2, Observer-Blind, Placebo-Controlled, Randomized Study
Session: Poster Abstract Session: Vaccines: Adolescent HPV and Meningococcal
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • GSK-IDWEEK 2016-V102_03 v3 (1024).pdf (453.9 kB)
  • Background: The MenABCWY vaccine combines antigens against the 5 serogroups of N. meningitidis responsible for most cases of meningococcal disease globally. Previously we studied the immunogenicity of 2 doses (0,2 months schedule) of MenABCWY in adolescents compared to 4CMenB and Placebo/MenACWY (NCT01272180). This study evaluated antibody persistence 2 years after primary vaccination, and response to a MenABCWY booster dose (NCT01992536).

    Methods: 194 adolescents who had participated in the primary study were enrolled and vaccinated. Antibodies against serogroups A, B, C, W and Y were measured by serum bactericidal assay with human complement (hSBA). Safety was assessed by frequencies of solicited and unsolicited adverse events (AEs).

    Results: At 2 years after the primary vaccination series, 27%, 29% and 31% of MenABCWY, 4CMenB and Placebo/MenACWY vaccinees, respectively, had hSBA titers ≥8 against serogroup A; 67%, 45% and 57% against serogroup C; 92%, 76% and 68% against serogroup W and 65%, 16% and 46% against serogroup Y. One month after the MenABCWY booster dose, 96% of MenABCWY, 100% of 4CMenB and 84% of Placebo/MenACWY vaccinees demonstrated seroresponses against serogroup A, 85%, 100% and 95% against serogroup C, 85%, 82% and 83% against serogroup W and 96%, 73% and 95% against serogroup Y. At 2 years post-vaccination, percentages of subjects with hSBA titers ≥5 against the 4 serogroup B test strains were 24%–35% for NadA in the MenABCWY and 4CMenB groups vs 7% in the Placebo/MenACWY group, 37%–50% vs 22% for NHBA, 26%–29% vs 14% for fHbp and 16%–24% vs 3% for PorA, respectively. One month after the MenABCWY booster dose, percentages of subjects with hSBA titers ≥5 across strains increased to 82%–100% in the MenABCWY and 4CMenB groups, and to 19%–35% in the Placebo/MenACWY group. The most frequent solicited AEs were injection site pain (77%–100% across groups), fatigue (35%–52%), and headache (27%–57%).

    Conclusion: Antibody persistence was substantial for most vaccine antigens 2 years after primary vaccination. A MenABCWY booster dose elicited robust immune responses to serogroups ACWY in adolescents previously vaccinated with MenABCWY, 4CMenB and Placebo/MenACWY, and to serogroup B strains in subjects who previously received MenABCWY or 4CMenB.

    Funding: GlaxoSmithKline Biologicals SA

    Leszek Szenborn, MD1, Stan L. Block, MD2, Teresa Jackowska, MD3, Wendy Daly, MD4,5, Jo Anne Welsch, PhD6, Diego D'agostino, MSc6, Linda Han, MD7 and Igor Smolenov, MD8, (1)Department of Pediatric Infectious Diseases, Wroclaw Medical University, Wroclaw, Poland, (2)Kentucky Pediatric and Adult Research Inc, Bardstown, KY, (3)Department of Pediatrics, The Centre of Postgraduate Medical Education, Warsaw, Poland, (4)Bluegrass Clinical Research Inc, Louisville, KY, (5)Brownsboro Park Pediatrics, Louisville, KY, (6)GlaxoSmithKline BV, Amsterdam, Netherlands, (7)Novartis Vaccines and Diagnostics Inc, Cambridge, MA, (8)Novartis Vaccines, Amsterdam, Netherlands

    Disclosures:

    L. Szenborn, None

    S. L. Block, Novartis Vaccines (now a GSK company): Grant Investigator , Research grant

    T. Jackowska, None

    W. Daly, None

    J. A. Welsch, GSK group of companies: Employee , Salary
    Novartis Vaccines (now a GSK company): former employee , Salary

    D. D'agostino, GSK group of companies: Employee , Salary
    Novartis Vaccines (now a GSK company): former employee , Salary

    L. Han, Novartis Vaccines (now a GSK company): former employee and Shareholder , Salary and stocks

    I. Smolenov, Novartis Vaccines (now a GSK company): former employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.