Safety and Immunogenicity of V114, a 15-valent Pneumococcal Conjugate Vaccine, in Children with Sickle Cell Disease (PNEU-SICKLE).

Sickle cell disease (SCD) is an inherited red blood cell disease that results in a multitude of medical complications, including increased risk of invasive disease caused by encapsulated bacteria such as Streptococcus pneumoniae. Pneumococcal vaccines have contributed to significant reduction in pneumococcal disease (PD) in children and adults, including those with SCD. This phase 3 study evaluated the safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine (PCV), in children with SCD. A total of 103 children 5 to 17 years of age with SCD were randomized and received a single dose of V114 or Prevnar 13™ (PCV13). Safety was evaluated as the proportion of participants with adverse events (AEs). Serotype-specific immunoglobulin G (IgG) and opsonophagocytic activity (OPA) were measured immediately prior to and 30 days after vaccination. Overall, rates of injection-site and systemic AEs reported postvaccination were similar between vaccination groups. Up to 6 months postvaccination, serious AEs were those expected in SCD patients, and none was assessed to be vaccine related. IgG geometric mean concentrations (GMCs) and OPA geometric mean titers (GMTs) for 13 shared serotypes were generally comparable between recipients of V114 and PCV13. Additionally, V114 induced immune responses to serotypes 22F and 33F, not included in PCV13. Safety and tolerability profiles of V114 were consistent to those reported with PCV13. Immune responses following vaccination with V114 were generally comparable to PCV13 for the shared serotypes and higher for unique serotypes 22F and 33F. These results support the use of V114 in children with SCD. Trial Registration: ClinicalTrials.gov: NCT03731182; EudraCT: 2018-001152-35.