745. Immunogenicity and Safety of Bivalent rLP2086, a Meningococcal Serogroup B Vaccine, Coadministered with Tdap and MCV4 in US Adolescents
Session: Oral Abstract Session: Vaccines: New and Established
Friday, October 9, 2015: 10:45 AM
Room: 5--AB
Background: Bivalent rLP2086 offers the potential to extend prevention of meningococcal disease beyond that provided by quadrivalent ACWY vaccines, to include serogroup B disease. Concurrent administration of bivalent rLP2086 with vaccines recommended in the US for adolescents and young adults may improve adherence to vaccine schedules. The objective of this study was to determine if immune responses induced by coadministration of Menactra [meningococcal A, C, Y and W-135 polysaccharide conjugate vaccine (MCV4)] and Adacel [tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine (Tdap)] with Trumenba [meningococcal B (MnB) vaccine, approved in the United States (bivalent rLP2086)] were noninferior to MCV4+Tdap or bivalent rLP2086 alone.   Methods: Healthy adolescents aged ≥10 to <13 years received MCV4+Tdap+bivalent rLP2086, MCV4+Tdap, or bivalent rLP2086. Bivalent rLP2086 immunogenicity was assessed by serum bactericidal assay using human complement (hSBA) with 2 MnB test strains expressing vaccine-heterologous fHBP variants; multiplexed Luminex assays and/or rabbit SBAs assessed immunogenicity of MCV4/Tdap antigens. Safety was assessed.

 

Results: 2648 subjects received MCV4+Tdap+bivalent rLP2086, MCV4+Tdap, or bivalent rLP2086. Immune responses to MCV4, Tdap, and bivalent rLP2086 given concomitantly were noninferior to immune responses to MCV4+Tdap or bivalent rLP2086 alone. 62.368.0% and 87.590% of MCV4+Tdap+bivalent rLP2086 recipients after dose 2 or dose 3, respectively, had seroprotective hSBA titers to 2 MnB test strains; bivalent rLP2086 alone induced similar responses (Table). Concomitant administration did not significantly increase local reactions or systemic events compared to bivalent rLP2086 alone.

  Conclusion: Bivalent rLP2086 given concomitantly with MCV4+Tdap met all noninferiority immunogenicity criteria without a clinically significant increase in reactogenicity. The ability to administer MCV4 and MnB vaccines would provide coverage against the 5 serogroups causing the majority of meningococcal disease. Convenience associated with concomitant administration of vaccines recommended for use in adolescents and young adults may improve adherence to recommended schedules.

Derek Muse, MD1, Shane Christensen, MD2, Prakash Bhuyan, MD, PhD3, Judith Absalon, MD, MPH4, Joseph Eiden, MD, PhD5, Thomas R. Jones, PhD6, Laura J. York, PhD7, Kathrin U. Jansen, PhD4, Robert E. O'neill, PhD6, Shannon L. Harris, PhD4 and John L. Perez, MD, MA5, (1)Jean Brown Research, Salt Lake City, UT, (2)Foothill Family Clinic, Salt Lake City, UT, (3)Pfizer Vaccine Clinical Research, Collegeville, PA, (4)Pfizer Vaccine Research, Pearl River, NY, (5)Pfizer Vaccine Research, Collegeville, PA, (6)Pfizer Vaccine Research Operations and Strategy, Pearl River, NY, (7)Pfizer Medical and Scientific Affairs, Collegeville, PA

Disclosures:

D. Muse, None

S. Christensen, J Lewis Research: Investigator , Research support

P. Bhuyan, Pfizer: Employee , Salary

J. Absalon, Pfizer Inc: Employee , Salary

J. Eiden, Pfizer, Inc.: Employee and Shareholder , Salary

T. R. Jones, Pfizer: Employee and Shareholder , Salary

L. J. York, Pfizer: Employee , Salary

K. U. Jansen, Pfizer Inc: Employee and Shareholder , Salary

R. E. O'neill, Pfizer: Employee , Salary

S. L. Harris, Pfizer: Employee and Shareholder , Salary

J. L. Perez, Pfizer: Employee , Salary

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