Program Schedule

1082
Safety, Tolerability, and Immunogenicity of an Investigational Meningococcal Serogroup B Bivalent rLP2086 Vaccine in Healthy Adolescents Aged 11 to 18 Years in Three Phase 2, Randomized, Controlled Studies

Session: Poster Abstract Session: Vaccines: Meningococcal
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • MNB14185.3009.pdf (1.4 MB)
  • Background: Neisseria meningitidis serogroup B (MnB) is a major cause of invasive meningococcal disease in adolescents. A conserved, surface-exposed lipoprotein, LP2086 (factor H binding protein [fHBP]), is a promising vaccine target to protect against invasive disease caused by MnB. Safety, tolerability, and immunogenicity of an investigational bivalent, recombinant MnB vaccine (bivalent rLP2086) were examined in three phase 2, randomized, controlled studies in healthy adolescents 1118 years of age. Methods: Study 1012 examined 5 vaccine regimens of bivalent rLP2086, whereas studies 1010 and 1011 evaluated a 3-dose schedule of bivalent rLP2086 vaccine given concomitantly with the TdaP-IPV and HPV-vaccines, respectively. Each dose of bivalent rLP2086 contained 60 µg of the rLP2086 subfamily A variant A05 and 60 µg of the rLP2086 subfamily B variant B01. To assess immunogenicity, serum bactericidal assays using human complement (hSBA) were performed with 4 MnB test strains expressing the heterologous fHBP variants A22, A56, B24 and B44, which were selected to represent relevant diversity of fHBP, as well as to provide a perspective on the breadth of the vaccine-elicited immune response against strain expressing epidemiologically prevalent fHBP variants.  Adverse events (AEs) and solicited local and systemic reactions were assessed. Results: A large number of subjects in all 3 studies achieved hSBA titers above the lower limit of quantification (LLOQ) for each of the 4 MnB test strains 1 month after dose 3 (Table). Most systemic events and local reactions were mild to moderate in severity; AEs were generally not serious or vaccine-related. Co-administration of rLP2086 with TdaP-IPV or HPV-vaccines did not interfere with immune responses elicited by rLP2086. Conclusion: Serum bactericidal antibody titers above 1:4 protect against invasive meningococcal disease. The demonstration of hSBA titers ≥LLOQ to 4 MnB test strains, each heterologous to vaccine antigen, in each of these adolescent  phase 2 studies,  suggest that 3 doses of the bivalent rLP2086 vaccine provided a functional antibody response that may be broadly active against diverse MnB disease-associated strains. Vaccinations with the bivalent rLP2086 were generally well tolerated.   Picture1.png
    Timo Vesikari, MD, PhD1, Johannes Beeslaar, MD2, Joseph Eiden, MD, PhD3, Qin Jiang, PhD2, Shannon Harris, PhD2, Laura J. York, PhD2, Diana Morgenstern, MD2, Prakash Bhuyan, MD, PhD2 and John L. Perez, MD2, (1)University of Tampere Medical School, Tampere, Finland, (2)Pfizer Vaccine Research, Collegeville, PA, (3)Pfizer Vaccine Research, Pearl River, NY

    Disclosures:

    T. Vesikari, None

    J. Beeslaar, Pfizer: Employee, Salary

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

    Q. Jiang, Pfizer: Employee, Salary and Stock option

    S. Harris, Pfizer: Employee, Salary

    L. J. York, Pfizer: Employee and Shareholder, Salary

    D. Morgenstern, Pfizer, Inc.: Employee and Shareholder, Salary and stock

    P. Bhuyan, Pfizer: Employee, Salary

    J. L. Perez, Pfizer: 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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