Program Schedule

1085
Persistence of Meningococcal Bactericidal Antibodies and Booster Response at 60-Months of Age in Children Who Received Infant Or Toddler Doses of MenACWY-CRM Conjugate Vaccine

Session: Poster Abstract Session: Vaccines: Meningococcal
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • Klein_et_al_IDWPoster.pdf (201.8 kB)
  • Background: A quadrivalent meningococcal glycoconjugate vaccine (MenACWY-CRM) is immunogenic in 4-dose infant or 2-dose toddler schedules. We report on persistence of bactericidal antibodies in each group at 60 months of age, and responses 1 month after a booster.

    Methods: In this phase IIIb, multi-center, open-label, controlled study (clinicaltrials.gov NCT01148017), subjects vaccinated as infants or toddlers were re-evaluated at 60 months of age, with age-matched vaccine-naïve controls. Bactericidal antibodies with human complement (hSBA) measured before and 1 month after booster are expressed as geometric mean titers (GMT) and proportions with seroprotective titers (≥ 8).

    Results: We enrolled 131 infant- and 54 toddler-vaccinated subjects, and 50 controls. At 60 months titers had waned, but GMTs were higher in toddler-vaccinated than in infant-vaccinated, and both were higher than controls. Immune responses to another dose of MenACWY-CRM were higher in both prevaccinated groups, who displayed anamnestic responses. GMTs for serogroups A, C, W, and Y were 177, 206, 1706 and 1135 in infant-vaccinated, 356, 723, 1960 and 1187 in toddler-vaccinated, and 47, 44, 37 and 18 in controls, respectively; 96–100% developed titers ≥ 8 compared with 73–89% of controls (Table).

     

    Percentages with hSBA ≥ 8 [95%CI]

    Group

    Infant

    (4 doses)

    Toddler

    (2 doses)

    Controls

    Timing

    Preboost

    Postboost

    Preboost

    Postboost

    Preboost

    Postboost

    n/N

    7/122

    111/115

    12/48

    45/45

    1/45

    39/45

    Serogroup A

    6

    [2, 11]

    97

    [91, 99]

    25

    [14, 40]

    100

    [92, 100]

    2

    [0.1, 12]

    87

    [73, 95]

    n/N

    32/122

    109/114

    26/48

    44/44

    10/45

    38/45

    Serogroup C

    26

    [19, 35]

    96

    [90, 99]

    54

    [39, 69]

    100

    [92, 100]

    22

    [11, 37]

    84

    [71, 94]

    n/N

    82/120

    103/103

    38/47

    42/42

    18/45

    39/44

    Serogroup W

    68

    [59, 77]

    100

    [96, 100]

    81

    [67, 91]

    100

    [92, 100]

    40

    [26, 56]

    89

    [75, 96]

    n/N

    68/121

    110/110

    35/48

    44/44

    11/44

    32/44

    Serogroup Y

    56

    [47, 65]

    100

    [97, 100]

    73

    [58, 85]

    100

    [92, 100]

    25

    [13, 40]

    73

    [57, 85]

     

    MenACWY-CRM vaccination at 60 months caused mainly mild or moderate solicited reactions in 62% of infant, 64% of toddler and 76% of control groups. No SAEs were reported.

    Conclusion: Modest antibody persistence after infant or toddler vaccination with MenACWY-CRM was observed at 60 months of age with a robust booster effect and high seroprotection rates postvaccination.

    Nicola P. Klein, MD, PhD, Kaiser Permanente Vaccine Study Center, Oakland, CA, Stan L. Block, MD, Kentucky Pediatric Research Center, Bardstown, KY, William Johnston, MD, Alabama Clinical Therapeutics, Birmingham, AL, Sandra Percell, PhD, Novartis Vaccines and Diagnostics, Inc., Cambridge, MA, Linda Han, MD, Novartis Vaccines and Diagnostics Inc., Cambridge, MA, Peter M Dull, MD, Novartis Vaccines and Diagnostics,Inc., Cambridge, MA and Igor Smolenov, MD, Novartis Vaccines and Diagnostics Inc., Cambridge, MA

    Disclosures:

    N. P. Klein, GSK: Investigator and Research Contractor, Research grant
    Merck: Investigator and Research Contractor, Research grant
    Pfizer: Investigator and Research Contractor, Research grant
    Novatis: Investigator and Research Contractor, Research grant
    MedImmune: Investigator and Research Contractor, Research grant
    Sanofi Pasteur: Investigator and Research Contractor, Research grant
    Nuron Biotech: Investigator and Research Contractor, Research grant

    S. L. Block, Novartis: Research Contractor, Research grant

    W. Johnston, Novartis: Research Contractor, Research grant

    S. Percell, Novartis Vaccines: Employee, Salary

    L. Han, Novartis Vaccines: Employee, Salary

    P. M Dull, Novartis Vaccines : Employee, Salary

    I. Smolenov, Novartis Vaccines: Employee, Salary

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