Alison Kent1, Shamez N Ladhani2, Nick J Andrews3, Tim Scorrer4, Andrew J Pollard5, Paul Clarke6, Stephen M Hughes7, Carrie Heal8, Esse Menson9, John Chang10, Prakash Satodia11, Andrew C Collinson12, Saul N Faust13, David Goldblatt14, Elizabeth Miller2, Paul T Heath15. 1. Paediatric Infectious Diseases Research Group and Vaccine Institute, St George's, University of London, London, United Kingdom; alisonkent@doctors.org.uk. 2. Immunization, Hepatitis and Blood Safety Department and. 3. Statistics, Modelling and Economics Department, Public Health England, Colindale, London, United Kingdom; 4. Neonatal Unit, Queen Alexandra Hospital, Portsmouth, United Kingdom; 5. Oxford Vaccine Group, University of Oxford, and the NIHR Oxford Biomedical Research Centre, Oxford, United Kingdom; 6. Neonatal Unit, Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, United Kingdom; 7. Department of Immunology, Royal Manchester Children's Hospital, Manchester, United Kingdom; 8. Neonatal Unit, Stepping Hill Hospital, Stockport, United Kingdom; 9. Department of Paediatric Infectious Diseases, Evelina London Children's Hospital, London, United Kingdom; 10. Neonatal Unit, Croydon University Hospital, London, United Kingdom; 11. Neonatal Unit, University Hospital Coventry and Warwickshire NHS Trust, Coventry, United Kingdom; 12. Neonatal Unit, Royal Cornwall Hospital, Truro, United Kingdom; 13. NIHR Welcome Trust Clinical Research Facility, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom; and. 14. Institute of Child Health, UCL, London, England. 15. Paediatric Infectious Diseases Research Group and Vaccine Institute, St George's, University of London, London, United Kingdom;
Abstract
BACKGROUND AND OBJECTIVE: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. METHODS: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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
BACKGROUND AND OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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: Elsbeth D M Rouers; Patricia C J Bruijning-Verhagen; Pieter G M van Gageldonk; Josephine A P van Dongen; Elisabeth A M Sanders; Guy A M Berbers Journal: JAMA Date: 2020-09-15 Impact factor: 56.272
Authors: Scott M Baliban; Brittany Curtis; Deanna Toema; Sharon M Tennant; Myron M Levine; Marcela F Pasetti; Raphael Simon Journal: PLoS Negl Trop Dis Date: 2018-05-23