720. Immunogenicity of MenB-FHbp (Bivalent rLP2086), a Meningococcal Serogroup B Vaccine, in US Adolescents: Results From a Phase 3 Trial
Session: Poster Abstract Session: Vaccines: Adolescent HPV and Meningococcal
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • 720.Vesikari.pdf (1.0 MB)
  • Background:  MenB-FHbp (bivalent rLP2086), which targets meningococcal serogroup B (MnB) factor H binding proteins (fHBP), was the first vaccine approved in the US to prevent MnB disease in persons aged 10–25 years. US-specific data in adolescents are particularly relevant because of MnB outbreaks on US college campuses. FDA approved the vaccine through an accelerated process using a serologic surrogate for efficacy that demonstrated vaccine induction of bactericidal antibodies against MnB strains expressing diverse fHBPs. Immunogenicity data are presented from a confirmatory pivotal phase 3 trial of MenB-FHbp, in which half of subjects were enrolled in the US, to extend phase 2 data, the basis for accelerated approval in the US.

    Methods:  Healthy subjects aged 10–<19 years were randomized to receive 1 of 3 lots of (MenB-FHbp) at 0, 2, and 6 months, or hepatitis A virus vaccine at 0 and 6 months and saline at 2 months. Immune responses were assessed by serum bactericidal assays using human complement (hSBAs) with 4 primary MnB test strains expressing vaccine-heterologous fHBP variants. Coprimary immunogenicity endpoints were proportion of subjects with a ≥4-fold increase in hSBA titers from baseline for each test strain and proportion achieving hSBA titers ≥ lower limit of quantification for all 4 test strains combined (composite response) after dose 3. Lot consistency was assessed with hSBA geometric mean titers (GMTs) for 2 primary MnB test strains after dose 3 (2-fold margin for equivalence). The study was powered to assess immunogenicity in US and total populations.

    Results:  50.2% of subjects were enrolled in the US. 1359 US subjects received MenB-FHbp. 81.9%–92.0% of subjects had ≥4-fold rise in hSBA titers from baseline to 1 month after dose 3 against each primary strain (Figure); 85.7% achieved a composite response after dose 3. Corresponding results after dose 2 were 55.5%–87.3% and 50.5%, respectively. hSBA GMTs were similar for all 3 vaccine lots (GMT ratio range: 0.87–1.04). Lower confidence interval threshold criteria were achieved for US subjects; thus coprimary endpoints were met.

    Conclusion:  As in the global study, MenB-FHbp elicited robust and broad immune responses in US adolescents after 3 doses. Vaccine lots were similar.

     

     

    Timo Vesikari, MD, PhD1, Shelly Senders, MD2, Judith Absalon, MD, MPH3, Joseph J. Eiden, MD, PhD3, Kathrin U. Jansen, PhD3, Johannes F. Beeslaar, MD4, Laura J. York, PhD5, Thomas R. Jones, PhD3, Roger Maansson, MS6, Shannon L. Harris, PhD3, Robert E. O'neill, PhD3, John Ginis, BS6, Annaliesa S. Anderson, PhD3 and John L. Perez, MD, MA6, (1)Vaccine Research Center, University of Tampere, Tampere, Finland, (2)Senders Pediatrics, South Euclid, OH, (3)Pfizer Vaccine Research, Pearl River, NY, (4)Pfizer Ltd, Walton Oaks, United Kingdom, (5)Pfizer Medical Development and Scientific Affairs, Collegeville, PA, (6)Pfizer Vaccine Research, Collegeville, PA

    Disclosures:

    T. Vesikari, None

    S. Senders, None

    J. Absalon, Pfizer, Inc: Employee , Salary

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

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

    J. F. Beeslaar, Pfizer Ltd: Employee and Shareholder , Salary and Stock, Stock options, and long term projections

    L. J. York, Pfizer, Inc: Employee , Salary

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

    R. Maansson, Pfizer, Inc: Employee and Shareholder , Salary and Stock Options

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

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

    J. Ginis, Pfizer, Inc: Employee , Salary

    A. S. Anderson, Pfizer, Inc: Employee , Salary

    J. L. Perez, Pfizer, Inc: Employee , Salary

    Findings in the abstracts are embargoed until 12:01 a.m. CDT, Wednesday Oct. 26th with the exception of research findings presented at the IDWeek press conferences.