540 - A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children with Sickle Cell Disease (PNEU–SICKLE)

Poster Number: 540
Publication Number: 540.328

Luwy K. Musey, Merck & Co., Inc., North Wales, PA, United States; Charles T. Quinn, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States; Richard T. Wiedmann, Merck & Co., Inc., North Wales, PA, United States; Melanie Papa, N/A, Upper Gwynedd, PA, United States; Qiong Shou, MSD R&D (China) Co., Ltd, Beijing, Beijing, China (People's Republic); Ron Dagan, Ben Gurion University - Israel, Beer Sheva, HaDarom, Israel; Kristen A. Feemster, Merck & Co., Inc, North Wales, PA, United States; Richard D. McFetridge, Merck & Inc., Kenilworth, NJ, United States; Gretchen Tamms, MSD, North Wales, PA, United States; Robert Lupinacci, Merck and Co., Inc., North Wales, PA, United States; Kara L. Bickham, Merck, Princeton, NJ, United States

Background: Disease caused by Streptococcus pneumoniae is a source of morbidity and mortality in children and adults globally.  Immunocompromised children, such as those with sickle cell disease (SCD), are even more susceptible.  Pneumococcal vaccines have demonstrated effectiveness in individuals with SCD, but development of higher valency pneumococcal vaccines is needed for broader protection against disease caused by serotypes not included in currently licensed pneumococcal vaccines. 

Objective: V114 is a 15-valent pneumococcal conjugate vaccine (PCV) currently approved for use in adults, that contains all 13 serotypes in Prevnar 13™ (PCV13) as well as epidemiologically important serotypes 22F and 33F.

Design/Methods: This Phase 3 study enrolled 5- to 17-year-old children with SCD who were randomized 2:1 to receive a single dose of V114 or PCV13, respectively.  Safety was evaluated following vaccination as the proportion of participants with adverse events (AEs).  Serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured immediately prior to and 30 days after vaccination using validated clinical assays.

Results: Reported injection-site, systemic, and serious AEs after vaccination were generally comparable between the 2 groups.  None of the reported serious AEs were determined to be related to the study vaccines.  Following vaccination, IgG GMCs and OPA GMTs in recipients of V114 were generally comparable to PCV13 for the 13 shared serotypes.  Additionally, a single dose of V114 induced immune responses to serotypes 22F and 33F.Conclusion(s): V114 was well tolerated in children with SCD with a generally comparable safety profile to that of PCV13.  Following a single vaccination, serotype-specific IgG GMCs and OPA GMTs were generally comparable between recipients of V114 and PCV13 for the 13 shared serotypes, and higher among recipients of V114 for serotypes 22F and 33F.  Study results support the use of V114 in children with SCD.