Program Schedule

1081
Immunogenicity of Human Papilloma Vaccine Coadministered with an Investigational Bivalent rLP2086 Vaccine Against Meningococcal Serogroup B in Healthy Adolescents

Session: Poster Abstract Session: Vaccines: Meningococcal
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • MNB14185.3008.pdf (1.1 MB)
  • Background: This Phase 2, randomized study evaluated coadministration of a licensed quadrivalent vaccine against human papillomavirus (HPV4) with bivalent rLP2086, an investigational vaccine against invasive disease caused by Neisseria meningitidis serogroup B (MnB), in healthy adolescents ≥11 to <18 years of age. Methods: Subjects received HPV4 + bivalent rLP2086 (Group 1), bivalent rLP2086 + saline (Group 2), or saline + HPV4 (Group 3) at months 0, 2, and 6. Sera were collected at baseline and after doses 2 and 3. Immune responses to HPV4 antigens (HPV-6, 11, 16, and 18) were determined by competitive Luminex immunoassays. Bivalent rLP2086 immunogenicity was measured by serum bactericidal assay using human complement (hSBA) to 4 MnB test strains expressing vaccine-heterologous fHBP variants (A22, A56, B24, B44). Primary immunogenicity endpoints, all after dose 3, included geometric mean titers (GMTs) against HPV antigens in Groups 1 and 3 and hSBA GMTs for strains expressing variants A22 and B24 in Groups 1 and 2. Secondary endpoints included seroconversion rates for HPV antigens in baseline seronegative subjects in Groups 1 and 3. Safety of bivalent rLP2086 was assessed after concomitant administration with HPV4 or saline. Results: The prespecified noninferiority criteria set at 1.5-fold (0.67 lower limit of 95% CI for GMRs) were met for 3 of 4 HPV antigens (not HPV-18) and both MnB test strains (Table 1). Seroconversion rates in Groups 1 and 3 were ≥99% for all HPV antigens (Table 2). Greater local reactogenicity occurred after rLP2086 compared with saline but did not increase with later doses; injection site pain was the most common local reaction. Systemic events in all 3 groups were generally mild and moderate in severity. Table1.gif Table2.gif Conclusion: Robust immune responses to both vaccines were generated after concomitant administration of rLP2086 + HPV4. Prespecified noninferiority criteria were met for 5 of 6 antigens. Although GMRs to HPV-18 narrowly missed noninferiority criteria, the high proportion of responders (≥99%) indicates clinical effectiveness is expected to be maintained after concomitant administration. Bivalent rLP2086 was well tolerated and elicited a robust immune response to test strains expressing fHPBs heterologous to those in the vaccine.
    Prakash Bhuyan, MD, PhD1, Joseph Eiden, MD, PhD2, Thomas R. Jones, PhD2, Laura J. York, PhD1, John Ginis1, Kathrin U. Jansen, PhD2, John L. Perez, MD1 and on behalf of the rLP2086 B1971011 study team , (1)Pfizer Vaccine Research, Collegeville, PA, (2)Pfizer Vaccine Research, Pearl River, NY

    Disclosures:

    P. Bhuyan, Pfizer: Employee, Salary

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

    T. R. Jones, Pfizer: Employee, Salary

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

    J. Ginis, Pfizer: Employee, Salary

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

    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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