Program Schedule

1084
Persistence of Meningococcal Antibodies and Response to a Booster Dose after a Two-dose Vaccination Series with Investigational MenABCWY Vaccine Formulations in Adolescents

Session: Poster Abstract Session: Vaccines: Meningococcal
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • 1084_IDPOSTER_XLlorenz.pdf (962.2 kB)
  • Background: Novartis has developed a glycoconjugate vaccine against Neisseria meningitidis serogroups A, C, W and Y (MenACWY-CRM), and a recombinant protein vaccine against serogroup B, and is now evaluating different formulations of a MenABCWY vaccine combining antigens against all 5 serogroups (clinicaltrials.gov NCT01367158).

    Methods: Among adolescents aged 11–18 years who had previously received 2 doses (0 and 2 months) of four different MenABCWY vaccines (with varying B components) or control vaccines, 440 subjects were enrolled to examine immune response to a third dose (4 months after dose 2), and antibody persistence 10 months after a 2-dose series. Antibodies against A, C, W, Y and B antigens were measured by serum bactericidal assay with human complement (hSBA). Frequencies of local and systemic reactions and other adverse events were assessed.

    Results: Prior to dose 3, 92–100% of subjects in all MenABCWY groups had hSBA titers ≥ 8 against serogroups C, W and Y, and 52–79% against A. One month after dose 3, 96–100% of subjects in all MenABCWY groups had hSBA titers ≥ 8 against A, C, W, and Y. After dose 3, percentages of subjects with hSBA titers ≥ 5 against serogroup B test strains increased  across MenABCWY groups, with highest percentages (87%–100%) being in subjects who received a MenABCWY vaccine containing outer membrane vesicles (OMV).

    Persistence of antibodies against A, C, W and Y, 10 months after dose 2 of MenABCWY was similar for all groups, and was at least equal to that after one dose of MenACWY-CRM. For all MenABCWY groups, antibody titers against B test strains declined most rapidly within 4 months after dose 2, and then declined gradually over the subsequent 6 months. Overall, the OMV-containing MenABCWY vaccines had the highest GMTs over time against most B test strains.

    Most frequent solicited reactions were injection site pain (71%), myalgia (42%), and headache (33%). OMV-containing MenABCWY groups had higher frequencies of local reactions, myalgia, and arthralgia.

    Conclusion: All MenABCWY vaccine formulations elicited robust immune responses to A, C, W, Y, and B after a third dose. Subjects given OMV-containing MenABCWY vaccines had the highest antibody titers against serogroup B test strains 10 months after dose 2.

    Xavier Saez-Llorens, MD1, Diana Catalina Aguilera Vaca, MD2, Katia Abarca, MD3, Emmanuelle Maho, M.Sc4, Linda Han, MD4, Igor Smolenov, MD5 and Peter Dull, MD4, (1)Hospital del Niņo, Panama City, Panama, (2)Centro de Investigacion,, Colombia, Colombia, (3)Pontificia Universidad Catolica de Chile, Santiago, Chile, (4)Novartis Vaccines and Diagnostics Inc., Cambridge, MA, (5)Novartis Vaccines and Diagnostics Inc., Cambridge, MA

    Disclosures:

    X. Saez-Llorens, Novartis Vaccines: Investigator, Consulting fee

    D. C. Aguilera Vaca, Novartis : Investigator, Consulting fee

    K. Abarca, Novartis Vaccines: Investigator, Consulting fee

    E. Maho, Novartis Vaccines: Employee, Salary

    L. Han, Novartis Vaccines: Employee, Salary

    I. Smolenov, Novartis Vaccines: Employee, Salary

    P. Dull, Novartis Vaccines: Employee, Salary

    Findings in the abstracts are embargoed until 12:01 a.m. EDT, Oct. 8th with the exception of research findings presented at the IDWeek press conferences.

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