13-valent pneumococcal conjugate vaccine (PCV13) is immunogenic and safe in children 6-17 years of age with sickle cell disease previously vaccinated with 23-valent pneumococcal polysaccharide vaccine (PPSV23): Results of a phase 3 study
Loading...
Date
Journal Title
Journal ISSN
Volume Title
Publisher
John Wiley and Sons Inc.
Abstract
Background: A large population of older children with sickle cell disease (SCD) is currently vaccinated with only 23-valent pneumococcal polysaccharide vaccine (PPSV23). In immunocompetent adults, PPSV23 vaccination reduces immune responses to subsequent vaccination with a pneumococcal vaccine. The 13-valent pneumococcal conjugate vaccine (PCV13), which addresses this limitation, may offer an advantage to this population at high risk of pneumococcal disease. Procedure: Children with SCD 6-17 years of age previously vaccinated with PPSV23 at least 6 months before study enrollment received two doses of PCV13 6 months apart. Anti-pneumococcal polysaccharide immunoglobulin G (IgG) geometric mean concentrations (GMCs) and opsonophagocytic activity (OPA) geometric mean titers (GMTs) were measured before, 1 month after each administration, and 1 year after the second administration. Results: Following each PCV13 administration, IgG GMCs and OPA GMTs significantly increased, and antibody levels after doses 1 and 2 were generally comparable. Antibody levels declined over the year following dose 2. At 1 year after the second administration, OPA GMTs for all and IgG GMCs for most serotypes remained above pre-vaccination levels. Most adverse events were due to vaso-occlusive crises, a characteristic of the underlying condition of SCD. Conclusions: Children with SCD who were previously vaccinated with PPSV23 responded well to 1 PCV13 dose, and a second dose did not increase antibody response. PCV13 antibodies persisted above pre-vaccination levels for all serotypes 1 year after dose 2. Children with SCD may benefit from at least one dose of PCV13. © 2015 Wiley Periodicals, Inc.
Description
Keywords
13-valent pneumococcal conjugate vaccine, 23-valent pneumococcal polysaccharide vaccine, Hydroxycarbamide, Immunogenicity, Safety, Sickle cell disease, Adolescent, Anemia, sickle cell, Antibodies, bacterial, Child, Female, Humans, Immunization, secondary, Immunoglobulin g, Male, Phagocytosis, Pneumococcal infections, Pneumococcal vaccines, Streptococcus pneumoniae, Vaccines, conjugate, Hydroxyurea, Pneumococcus vaccine, 23-valent pneumococcal capsular polysaccharide vaccine, Bacterium antibody, Prevenar13, Vaccine, Abdominal pain, Abscess, Acute chest syndrome, Acute cholecystitis, Antibody blood level, Antibody response, Antibody titer, Arthralgia, Article, Asthma, Backache, Bacteremia, Bone abscess, Bone disease, Brain infarction, Bronchitis, Cerebrovascular accident, Childhood disease, Chronic kidney failure, Constipation, Device infection, Drug dose regimen, Drug fever, Drug induced headache, Drug intoxication, Drug safety, Drug tolerability, Dysuria, Esophagitis, Fatigue, Flank pain, Follow up, Gastritis, Gastroenteritis, Geometric mean concentration, Geometric mean titer, Gingivitis, Groin abscess, Hematuria, Hemolytic anemia, Hepatitis a, Hiatus hernia, Human, Hyperbilirubinemia, Hypersplenism, Hypesthesia, Hypocalcemia, Immune response, Injection site pain, Injection site swelling, Jaw pain, Lethargy, Limb pain, Long term care, Lung infiltrate, Lymphadenopathy, Major clinical study, Migraine, Multicenter study, Muscle weakness, Musculoskeletal chest pain, Myalgia, Nausea, Open study, Opsonophagocytic activity, Osteomyelitis, Peripheral edema, Pharyngitis, Pharyngotonsillitis, Phase 3 clinical trial, Pneumococcal infection, Pneumonia, Priapism, Priority journal, Pyelonephritis, Respiratory failure, Rib fracture, Serotype, Sickle cell anemia, Single drug dose, Sinusitis, Skin redness, Staphylococcal bacteremia, Thorax pain, Tonsillitis, Upper respiratory tract infection, Urinary tract infection, Vaccination, Visual impairment, Blood, Clinical trial, Immunization, Immunology