Program Schedule

1102
Immunogenicity and Safety of a Second Administration of 13-Valent Pneumococcal Conjugate Vaccine Five Years after Initial Vaccination in Adults 50 Years and Older

Session: Poster Abstract Session: Vaccines: Pneumococcal
Friday, October 10, 2014
Room: The Pennsylvania Convention Center: IDExpo Hall BC
Posters
  • PAP14187.3028.pdf (1.1 MB)
  • Immunogenicity and Safety of a Second Administration of 13-Valent Pneumococcal Conjugate Vaccine Five Years after Initial Vaccination in Adults 50 Years and Older

    Background: Adults ≥50 years are at increased risk for invasive disease and pneumonia caused by S pneumoniae. Previously, we reported a study assessing simultaneous administration of 13-valent pneumococcal conjugate vaccine (PCV13) and trivalent inactivated influenza vaccine (TIV). We now present data on revaccination with PCV13 five years after initial vaccination.

    Methods: This was a phase 3, randomized trial. Pneumococcal vaccine-naive subjects, 50–59 years old, were vaccinated with PCV13 and TIV, given concomitantly or 1 month apart. All were revaccinated with PCV13 five years after initial vaccination. Blood samples were obtained before and approximately 1 month after each vaccination. Anti-pneumococcal polysaccharide immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) titers (GMTs) were determined. Local reactions and systemic events were collected for 14 days after revaccination, and adverse events (AEs) for 6 months. Deaths were recorded throughout the study.

    Results: 727 of the 1116 randomized subjects were revaccinated at year 5; 712 completed the 6-month follow-up. Mean age at revaccination was 59.8 ±2.8 years. For all serotypes, IgG GMCs (except serotype 3) and OPA GMTs before revaccination with PCV13 had declined in the 5 years since initial vaccination, but remained significantly higher than levels before initial vaccination. OPA GMTs and IgG GMCs significantly increased from before to 1 month after revaccination with PCV13. OPA GMTs (Table 1) and IgG GMCs (Table 2) were generally comparable or higher 1 month after revaccination compared to levels 1 month after initial PCV13 vaccination. Local reactions were mostly mild. Fever was reported by <4% of subjects; all <39.0°C. AEs were reported by <5% of subjects in the month after revaccination and <1% up to 6 months after revaccination. No serious AEs were vaccine-related. Seven deaths occurred in years 1–5, all before revaccination, none were vaccine-related.

    Conclusion: PCV13 revaccination 5 years after initial PCV13 vaccination in pneumococcal-naive 50–59 year-olds elicited generally comparable or higher antibody responses for all serotypes compared to initial PCV13 vaccination, and demonstrated an acceptable safety profile

    Robert W. Frenck Jr., MD1, Anne Fiquet, MD2, Alejandra Gurtman, MD3, Martin Van Cleeff, MD4, Matthew Davis, MD5, John Rubino, MD6, William Smith, MD7, Vani Sundaraiyer, PhD8, Mohinder Sidhu, PhD3, Emilio A. Emini, PhD3, William C. Gruber, MD3, Daniel A. Scott, MD3 and Beate Schmoele-Thoma, MD9, (1)Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, (2)Vaccines Clinical Research Pfizer Limited, Berkshire, United Kingdom, (3)Pfizer Inc, Pearl River, NY, (4)Cary Medical Research, Cary, NC, (5)Rochester Clinical Research, Rochester, NY, (6)Raleigh Medical Group/PMG Research, Raleigh, NC, (7)Volunteer Research Group at The University of Tennessee Medical Center, Knoxville, TN, (8)InVentiv Health Clinical, LLC, Princeton, NJ, (9)Pfizer Gmbh, Berlin, Germany

    Disclosures:

    R. W. Frenck Jr., Pfizer: Investigator, Funds for clinical trials
    GSK: Chairing a DSMB for upcoming trial and Investigator, Received funds for clinical trials
    Ligocyte (now Takeda): Investigator, Received funds for clinical trials

    A. Fiquet, Pfizer: Employee, Salary and stock options

    A. Gurtman, Pfizer: Employee, Salary

    M. Van Cleeff, None

    M. Davis, None

    J. Rubino, Pfizer: Investigator and Shareholder, Research grant

    W. Smith, Volunteer Research Group: Investigator, payment to conduct Clinical Research Trials

    V. Sundaraiyer, Pfizer: Employee of a CRO contracted to work on Pfizer projects, Service fee

    M. Sidhu, Pfizer Inc.: Employee, Salary

    E. A. Emini, Pfizer Inc.: Employee and Shareholder, Salary

    W. C. Gruber, Pfizer: Employee and Shareholder, Salary

    D. A. Scott, Pfizer: Employee and Shareholder, Salary

    B. Schmoele-Thoma, Pfizer Vaccines Clinical Research: Employee and Shareholder, 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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