title: Schedules for Pneumococcal Vaccination of Preterm Infants: An RCT.
abstract: Premature infants have a higher risk of invasive pneumococcal disease and are more likely to have lower vaccine responses compared with term infants. Increasingly, immunization schedules are including a reduced, 2-dose, pneumococcal conjugate vaccine priming schedule. Our goal was to assess the immunogenicity of 3 commonly used 13-valent pneumococcal conjugate vaccine (PCV13) priming schedules in premature infants and their response to a 12-month booster dose.
  
  
  
  Premature infants (<35 weeks' gestation) were randomized to receive PCV13 at 2 and 4 months (reduced schedule); 2, 3, and 4 months (accelerated schedule); or 2, 4, and 6 months (extended schedule). All infants received a 12-month PCV13 booster. Serotype-specific pneumococcal immunoglobulin G (IgG) for PCV13 serotypes was measured by using enzyme-linked immunosorbent assay 1 month after the primary and booster vaccinations.
  
  
  
  A total of 210 infants (median birth gestation, 29(+6) weeks; range, 23(+2)-34(+6) weeks) were included. After the primary vaccination, 75% (95% confidence interval [CI], 62-85), 88% (95% CI, 76-95), and 97% (95% CI, 87-99) of participants had protective antibody concentrations for at least one-half the PCV13 serotypes for the reduced, accelerated, and extended schedules, respectively. After the booster vaccination, participants receiving the extended schedule had significantly lower (P < .05) geometric mean concentrations compared with reduced (for 9 of 13 serotypes) and accelerated (for 4 of 13 serotypes) schedules, but nearly all participations, regardless of schedule or serotype, had seroprotective IgG concentrations.
  
  
  
  A reduced priming schedule of PCV13 resulted in higher post-booster IgG concentrations but lower post-primary concentrations. The optimum vaccine schedule for preterm infants will therefore depend on when they are most at risk for invasive pneumococcal disease.
authors: Paediatric Infectious Diseases Research Group and Vaccine Institute, St George's, University of London, London, United Kingdom; alisonkent@doctors.org.uk.
authors: Alison
authors: A
authors: Kent
authors: Immunization, Hepatitis and Blood Safety Department and.
authors: Shamez N
authors: SN
authors: Ladhani
authors: Statistics, Modelling and Economics Department, Public Health England, Colindale, London, United Kingdom;
authors: Nick J
authors: NJ
authors: Andrews
authors: Neonatal Unit, Queen Alexandra Hospital, Portsmouth, United Kingdom;
authors: Tim
authors: T
authors: Scorrer
authors: Oxford Vaccine Group, University of Oxford, and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom;
authors: Andrew J
authors: AJ
authors: Pollard
authors: Neonatal Unit, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, United Kingdom;
authors: Paul
authors: P
authors: Clarke
authors: Department of Immunology, Royal Manchester Children's Hospital, Manchester, United Kingdom;
authors: Stephen M
authors: SM
authors: Hughes
authors: Neonatal Unit, Stepping Hill Hospital, Stockport, United Kingdom;
authors: Carrie
authors: C
authors: Heal
authors: Department of Paediatric Infectious Diseases, Evelina London Children's Hospital, London, United Kingdom;
authors: Esse
authors: E
authors: Menson
authors: Neonatal Unit, Croydon University Hospital, London, United Kingdom;
authors: John
authors: J
authors: Chang
authors: Neonatal Unit, University Hospital Coventry and Warwickshire NHS Trust, Coventry, United Kingdom;
authors: Prakash
authors: P
authors: Satodia
authors: Neonatal Unit, Royal Cornwall Hospital, Truro, United Kingdom;
authors: Andrew C
authors: AC
authors: Collinson
authors: NIHR Welcome Trust Clinical Research Facility, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; and.
authors: Saul N
authors: SN
authors: Faust
authors: Institute of Child Health, UCL, London, England.
authors: David
authors: D
authors: Goldblatt
authors: Immunization, Hepatitis and Blood Safety Department and.
authors: Elizabeth
authors: E
authors: Miller
authors: Paediatric Infectious Diseases Research Group and Vaccine Institute, St George's, University of London, London, United Kingdom;
authors: Paul T
authors: PT
authors: Heath
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D015415:Biomarkers / Q000097:blood; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007074:Immunoglobulin G / Q000097:blood*; D007223:Infant; D007231:Infant, Newborn; D007234:Infant, Premature / Q000276:immunology*; D008297:Male; D017063:Outcome Assessment, Health Care; D022242:Pneumococcal Vaccines / Q000276:immunology*; D013296:Streptococcus pneumoniae / Q000276:immunology*; D014611:Vaccination / Q000379:methods*; D018074:Vaccines, Conjugate / Q000276:immunology
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; D015415:Biomarkers; D007074:Immunoglobulin G; D022242:Pneumococcal Vaccines; D018074:Vaccines, Conjugate