Program Schedule

1104
13-Valent Pneumococcal Conjugate Vaccine (PCV13) Immunogenicity in the Community Acquired  Pneumonia Immunization Trial In Adults (CAPiTA)

Session: Poster Abstract Session: Vaccines: Pneumococcal
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • PAP14187.3029_Final.pdf (1.5 MB)
  • Background: The CAPiTA study, which was a randomized, double-blind clinical trial in 84,496 participants 65 years of age and older in the Netherlands demonstrated efficacy against first episodes of vaccine type (VT) community acquired pneumonia and first episodes of VT-IPD. Results of the primary and secondary endpoints have been previously reported.

    Methods: A subset of the subjects (2,011) was enrolled utilizing home based visits in a single region in the Netherlands. Blood samples for immunogenicity analysis were taken at baseline before vaccination, one month, 12 months and 24 months after vaccination. Serotype specific opsonophagocytic activity (OPA) titers and anticapsular polysaccharide  immunoglobulin G (IgG) concentrations  (µg/mL) were measured at each of these time points for all PCV13 serotypes and compared to placebo.

    Results: For both OPA and IgG, there were significant increases in antibody levels for all serotypes one month after vaccination compared to before vaccination with PCV13. One month after vaccination the ratios for OPA geometric mean titers (GMTs) of PCV13 to placebo ranged from 4.4  (serotype 9V) to 62.6 (serotype 4); after 12 months the ratios ranged from 2.2 (serotype 9V) to 13.9 (serotype 4) and after 24 months  from 1.6 (serotype 9V) to 8.0 (serotype 4). 

    One month after vaccination the ratios for IgG geometric mean concentrations (GMCs) of PCV13 to placebo ranged from  2.97 (serotype 3) to 12.12 (serotype 18C); after 12 months the ratios ranged from 1.66 (serotype 3) to 5.72 (serotype 18C) and after 24 months  from 1.56 (serotype 3) to 4.76 (serotype 18C).

    The ratios for both OPA GMTs and IgG GMCs in the age subgroups ≥65 to <70 years; ≥70 to <80 years and ≥80 years followed a similar pattern indicating that measurable antibody responses extended out at least two years after vaccination for all age groups.

    Conclusion: The observed immune response data support the demonstrated efficacy of PCV13 against VT-CAP and VT-IPD in adults 65 years and older. Both binding IgG antibodies and functional OPA antibodies persisted at least two years after vaccination at levels above baseline. (Funded by Pfizer, Inc.; ClinicalTrials.govnumber NCT00744263.)

    Anna M.M. Van Deursen, MD1, Elisabeth a.M. Sanders, MD, PhD1, Chris Webber, MD, PhD2, Michael Patton2, Daniel a. Scott, MD3, Mohinder Sidhu4, Wayne Drews5 and Marc Bonten, MD PhD6,7, (1)Department of Immunology, Wilhelmina Children’s Hospital, UMC Utrecht, Utrecht, Netherlands, (2)Pfizer Vaccine Clinical Research, Maidenhead, United Kingdom, (3)Pfizer Vaccine Clinical Research, Pearl River, NY, (4)High Throughput Clinical Testing, Pfizer Vaccine R&D, Pearl River, NY, (5)inVentiv Health Clinical, LLC, Austin, TX, (6)Department of Medical Microbiology, University Medical Center Utrecht, Utrecht, Netherlands, (7)Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, Netherlands

    Disclosures:

    A. M. M. Van Deursen, None

    E. A. M. Sanders, Pfizer: Grant Investigator and Scientific Advisor, Consulting fee, Educational grant, Research grant and Research support
    GSK: Grant Investigator and Scientific Advisor, Consulting fee, Research grant and Research support

    C. Webber, Pfizer Vaccines Clinical Research: Employee and Shareholder, Salary

    M. Patton, Pfizer Vaccines Clinical Research: Employee and Shareholder, Salary

    D. A. Scott, Pfizer Vaccines Clinical Research: Employee and Shareholder, Salary

    M. Sidhu, Pfizer: Employee and Shareholder, Salary

    W. Drews, Pfizer: Independent Contractor, Consulting fee

    M. Bonten, Pfizer Vaccines Clinical Research: Investigator, Research grant

    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.

    Sponsoring Societies:

    © 2014, idweek.org. All Rights Reserved.

    Follow IDWeek