Abstract
BackgroundApproximately 826,000 children, mostly young infants, die annually from invasive pneumococcal disease. A 6-10-14-week schedule of pneumococcal conjugate vaccine (PCV) is efficacious but neonatal PCV may provide earlier protection and better coverage. We conducted an open randomized controlled trial in Papua New Guinea to compare safety, immunogenicity and priming for memory of 7-valent PCV (PCV7) given in a 0-1-2-month (neonatal) schedule with that of the routine 1-2-3-month (infant) schedule.MethodsWe randomized 318 infants at birth to receive PCV7 in the neonatal or infant schedule or no PCV7. All infants received 23-valent pneumococcal polysaccharide vaccine (PPV) at age 9 months. Serotype-specific serum IgG for PCV7 (VT) serotypes and non-VT serotypes 2, 5 and 7F were measured at birth and 2, 3, 4, 9, 10 and 18 months of age. Primary outcomes were geometric mean concentrations (GMCs) and proportions with concentration ≥0.35 µg/ml of VT serotype-specific pneumococcal IgG at age 2 months and one month post-PPV.ResultsWe enrolled 101, 105 and 106 infants, respectively, into neonatal, infant and control groups. Despite high background levels of maternally derived antibody, both PCV7 groups had higher GMCs than controls at age 2 months for serotypes 4 (p<0.001) and 9V (p<0.05) and at age 3 months for all VTs except 6B. GMCs for serotypes 4, 9V, 18C and 19F were significantly higher (p<0.001) at age 2 months in the neonatal (one month post-dose2 PCV7) than in the infant group (one month post-dose1 PCV7). PPV induced significantly higher VT antibody responses in PCV7-primed than unprimed infants, with neonatal and infant groups equivalent. High VT and non-VT antibody concentrations generally persisted to age 18 months.ConclusionsPCV7 is well-tolerated and immunogenic in PNG neonates and young infants and induces immunologic memory to PPV booster at age 9 months with antibody levels maintained to age 18 months.Trial RegistrationClinicalTrials.gov NCT00219401NCT00219401
Highlights
Every year an estimated 826,000 children under 5 years of age die of invasive pneumococcal disease (IPD, predominantly pneumonia, meningitis or sepsis), the majority in 3rd world countries [1]
In Papua New Guinea (PNG), where the present study was conducted, 26% and 63% of pneumococcal pneumonia in children occurs before ages 2 and 6 months, respectively, and approximately one-third of pneumococcal meningitis occurs before the age of 3 months [14]
In PNG we previously demonstrated efficacy of 23-valent pneumococcal polysaccharide vaccine (PPV) in preventing death and moderate-severe pneumonia when given at 6 months to 5 years of age; serotype-dependent maturation of antibody responses supported efficacy data [23,24,25]
Summary
Every year an estimated 826,000 children under 5 years of age die of invasive pneumococcal disease (IPD, predominantly pneumonia, meningitis or sepsis), the majority in 3rd world countries [1]. A multicentre study conducted in children aged ,3 months living in 3rd world countries, including Papua New Guinea (PNG), found that the pneumococcus was the most important cause of serious infections in the second and third month of life [13]. A 610-14-week schedule of pneumococcal conjugate vaccine (PCV) is efficacious but neonatal PCV may provide earlier protection and better coverage. We conducted an open randomized controlled trial in Papua New Guinea to compare safety, immunogenicity and priming for memory of 7-valent PCV (PCV7) given in a 0-1-2-month (neonatal) schedule with that of the routine 1-2-3-month (infant) schedule
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