1972. Safety and Immunogenicity of 15-Valent Pneumococcal Conjugate Vaccine (PCV-15) Compared to PCV-13 in Healthy Older Adults Previously Vaccinated with 23-Valent Pneumococcal Polysaccharide Vaccine (PPV23)
Session: Poster Abstract Session: Clinical Trials
Saturday, October 6, 2018
Room: S Poster Hall
Posters
  • V114-007_IDWeek_Poster_final.pdf (783.7 kB)
  • Background:

    Safety and immunogenicity of a new formulation of PCV-15 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F, 19A, 22F*, 23F, 33F*) was evaluated in adults ≥65 years of age previously vaccinated with PPV23.

    Methods:

    Study subjects who received PPV23 at least 1 year prior to study entry received a single dose of either PCV-15 or PCV-13 (125/arm) and were followed for safety for 14 days postvaccination. Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior and 30 days postvaccination. NCT02573081

    Results:

    Safety profiles were comparable between PCV-15 and PCV-13 recipients. Following vaccination, serotype- specific antibody responses for the 13 shared serotypes were generally comparable between recipients of PCV- 15 and PCV-13 for IgG GMCs and geometric mean fold rises (GMFRs), OPA GMTs and GMFRs, and percentages of subjects with ≥4-fold-rise from baseline. Recipients of PCV-15 had numerically higher IgG GMCs and OPA GMTs than PCV-13 recipients for two serotypes unique to PCV-15 (22F, 33F).

    Conclusion:

    PCV-15 was generally well tolerated when given as a single dose to adults ≥65 years of age previously vaccinated with PPV23. Following vaccination, serotype-specific IgG GMCs and OPA GMTs were comparable between recipients of PCV-15 and PCV-13 for 13 shared serotypes.

    *Not shared serotypes with PCV-13

    Ulrike Buchwald, MD1, James Peterson, MD2, Helen Stacey, MD3, Katie Julien, MD4, Tina Sterling, BSN1, Melanie Bruch, MD1, Gretchen Tamms, BS1, Jianing Li, PhD1, Alison Pedley, PhD1, Katrina Nolan, MD1, Patrice Benner, MD1, Chitrananda Abeygunawardana, MD1, Michael Winters, PhD5, Michael Kosinski, PhD1, Jon Stek, BS1 and Luwy Musey, MD1, (1)Merck & Co., Inc., Kenilworth, NJ, (2)J Lewis Research, Salt Lake City, UT, (3)Diablo Clinic, Walnut Creek, CA, (4)Jordan River Family Medicine, South Jordan, UT, (5)Merck & Co. Inc., Kenilworth, NJ

    Disclosures:

    U. Buchwald, Merck: Employee and Shareholder , Salary and stock options .

    J. Peterson, Merck: Investigator , Research grant .

    H. Stacey, Merckl: Investigator , Research grant .

    K. Julien, Merck: Investigator , Research grant .

    T. Sterling, Merck: Employee and Shareholder , Salary and stock options .

    M. Bruch, Merck: Employee and Shareholder , Salary and stock options .

    G. Tamms, Merck: Employee and Shareholder , Salary and stock options .

    J. Li, Merck: Employee and Shareholder , Salary and stock options .

    A. Pedley, Merck: Employee and Shareholder , Salary and stock options .

    K. Nolan, Merck: Employee and Shareholder , Salary and stock options .

    P. Benner, Merck: Employee and Shareholder , Salary and stock options .

    C. Abeygunawardana, Merck: Employee and Shareholder , Salary and stock options .

    M. Winters, Merck: Employee and Shareholder , Salary and stock options .

    M. Kosinski, Merck: Employee and Shareholder , Salary and stock options .

    J. Stek, Merck: Employee and Shareholder , Salary and stock options .

    L. Musey, Merck: Employee and Shareholder , Salary and stock options .

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