Program Schedule

1083
Comparative Evaluation of Two Different Investigational Meningococcal ABCWY Vaccine Formulations in Adolescents and Young Adults

Session: Poster Abstract Session: Vaccines: Meningococcal
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • 1083_IDPOSTER_SBLOCK.pdf (788.9 kB)
  • Background:

    Novartis has licensed meningococcal vaccines against serogroups A, C, W and Y (MenACWY-CRM) and serogroup B (4CMenB). We evaluated 2 investigational formulations of MenABCWY vaccines, with primary objectives to assess their noninferiority compared with the licensed vaccine for ACWY serogroups and formulation selection based on a desirability index (DI) (Clinicaltrials.gov NCT01272180).

    Methods: 480 healthy subjects, aged 10–25 years, were randomized to four groups and received either: one of two MenABCWY formulations with full or quarter doses of outer membrane vesicles (OMV), 4CMenB, or Placebo/MenACWY-CRM. Each was given as a 2-dose series at 0 and 2 months. A serum bactericidal assay with human complement (hSBA) was used to measure antibodies against serogroups A, C, W, Y and serogroup B test strains at baseline and 30 days after dose 2; seroresponses and hSBA GMTs were assessed. For MenABCWY vaccines we also compared a DI based on immunogenicity (post-vaccine hSBA GMT ratios) and reactogenicity parameters (percentages of doses associated with severe local and severe systemic reactions).

    Results: Percentages of subjects with seroresponses to A, C, W and Y were significantly higher after 2 doses of either MenABCWY formulation (with full and quarter OMV) than after a single dose of MenACWY; respectively 90/92% vs 73% for A; 95/93% vs 63% for C; 80/84% vs 65% for W; and 92/90% vs 75% for Y. Prespecified noninferiority criteria were met. Both MenABCWY vaccines induced robust immune responses against serogroup B test strains, comparable with 4CMenB. Among the three serogroup B-containing formulations, DI analyses were comparable, although the full dose OMV vaccine induced higher GMTs than the quarter dose vaccine against most of the serogroup B test strains. Reactogenicity profiles of the MenABCWY vaccines were similar to each other and to that of 4CMenB. No vaccine-related serious adverse events were reported.

    Conclusion: The MenABCWY vaccines had comparable immunogenicity for serogroups ACWY and for serogroup B, although GMT responses against B test strains appeared to be higher for the full OMV formulation. Reactogenicity was comparable between the investigational and the 4CMenB vaccine.

    Stan L. Block, MD1, Leszek Szenborn, MD2, Wendy Daly, MD3, Teresa Jackowska, MD4, Vas Narasimhan, MD5, Diego D'Agostino, M.Sc5, Linda Han, MD5, Peter M Dull, MD6 and Igor Smolenov, MD5, (1)Kentucky Pediatric and Adult Research Center, Bardstown, KY, (2)Clinic of Pediatrics and Infectious Diseases, Wroclaw, Poland, (3)Bluegrass Clinical Research Inc, Louisville, KY, (4)Department of Pediatrics, Medical Center of Postgraduate Education, Warsaw, Poland, (5)Novartis Vaccines and Diagnostics Inc., Cambridge, MA, (6)Novartis Vaccines and Diagnostics,Inc., Cambridge, MA

    Disclosures:

    S. L. Block, Novartis Vaccines: Investigator, Consulting fee

    L. Szenborn, Novartis Vaccines: Investigator, Consulting fee

    W. Daly, Novartis Vaccines: Investigator, Consulting fee

    T. Jackowska, Novartis Vaccines: Investigator, Consulting fee

    V. Narasimhan, Novartis Vaccines: Employee, Salary

    D. D'Agostino, Novartis Vaccines: Employee, Salary

    L. Han, Novartis Vaccines: Employee, Salary

    P. M Dull, Novartis Vaccines : Employee, Salary

    I. Smolenov, 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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