1348. Immunogenicity and safety of investigational vaccine formulations against meningococcal serogroups A, B, C, W, and Y in adolescents
Session: Poster Abstract Session: Clinical Trials
Saturday, October 5, 2013
Room: The Moscone Center: Poster Hall C
Posters
  • 1348_IDW Poster.pdf (657.1 kB)
  • Background:  We investigated novel formulations of meningococcal ABCWY vaccines in adolescents, using recombinant proteins (rMenB) and outer membrane vesicles (OMV) components of a European-approved serogroup B vaccine, with a licensed quadrivalent polysaccharide-protein conjugate ACWY vaccine (clinicaltrials.gov NCT01210885).

    Methods:  In this phase 2, multicenter, observer-blind, controlled study 495 (494 vaccinated) healthy 11-18 year-old adolescents were randomized to six study groups for two injections, two months apart, of the indicated vaccine formulations. Serum bactericidal activities with human complement (hSBA) were measured before and 1 month after each vaccination; adverse events were assessed throughout the study.                                                                                         

    Group

    N

    Vaccine components

    Schedule

    I

    81

    MenACWY + rMenB (1x)

    2 doses at 0 & 2 months

    II

    81

    MenACWY + rMenB (2x)

    2 doses at 0 & 2 months

    III

    83

    MenACWY + rMenB (1x) + OMV (1x)

    2 doses at 0 & 2 months

    IV

    82

    MenACWY + rMenB (1x) + OMV (1/4 x)

    2 doses at 0 & 2 months

    V

    85

    rMenB (1x)

    2 doses at 0 & 2 months

    VI

    82

    MenACWY

    MenACWY at 0, placebo at 2 months

     Results:

    Immunogenicity: After two vaccinations ACWY Groups I−IV seroresponse rates were: A (97−98%), C (95−97%), W (74−86%) and Y (92−96%), higher than in Group VI after one MenACWY vaccination, A (86%), C (68%), W (60%) and Y (78%). In Groups I−V, 94-100% elicited hSBA titers ≥ 5 to rMenB antigens after two doses, with only Groups III and IV having titers ≥ 5 to OMV (78% and 71%, respectively).

    Safety: Solicited local reaction rates were higher in Groups I−IV (84−90%) than Groups V (80%) or VI (60%) after one dose, but similar across groups after the second dose (65−84%), consisting mainly of transient injection site pain. Solicited systemic reactions, mainly myalgia and headache, were reported by 62−76% and 46−59% after doses 1 and 2, respectively in Groups I−V, and 55% and 56% in Group VI. Fever (≥ 38.0°C) was rare ranging from 2-6% across groups. There was no vaccine-related SAE.

    Conclusion:  Various investigational ABCWY formulations elicited responses similar to those anticipated from the constituent ACWY and B vaccines, with generally acceptable tolerability.

    Xavier Saez-Llorens, MD1, Maria-Gabriela Grana, MD2, Esther Heijinen, MD3, Igor Smolenov, MD3 and Peter Dull, MD4, (1)Infectious Diseases, Hosp. Del Ninos, Panama City, Panama, (2)Novartis Vaccines & Diagnostics, Buenos Aires, Argentina, (3)Novartis Vaccines and Diagnostics, Amsterdam, Netherlands, (4)Clinical Development, Novartis Vaccines and Diagnostics, Cambridge, MA

    Disclosures:

    X. Saez-Llorens, None

    M. G. Grana, Novartis Vaccines and Diagnostics: Employee, Salary and Stock Options

    E. Heijinen, Novartis Vaccines and Diagnostics: Employee, Salary and Stock Options

    I. Smolenov, Novartis Vaccines and Diagnostics: Employee, Salary and Stock Options

    P. Dull, Novartis Vaccines and Diagnostics: Employee, Salary and Stock Options

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