Τίτλος:
Immunization of preterm infants with 10-valent pneumococcal conjugate vaccine
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
OBJECTIVE: The safety and immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in preterm infants were assessed in this study. METHODS: Three parallel groups of infants received 3-dose primary immunization with PHiD-CV at 2, 4, and 6 months of age and a booster dose at 16 to 18 months: preterm I (gestation period ≥ 27 and <31 weeks, N = 50); preterm II (≥31 and <37 weeks, N = 87); and term (≥37 weeks, N = 149). Solicited symptoms and adverse events were recorded. Immune responses to PHiD-CV and coadministered vaccine antigens were measured. RESULTS: The incidence of solicited general symptoms was similar across groups, and the frequency of grade 3 general symptoms was low. Incidences of redness and swelling were generally lower in preterm infants. PHiD-CV was immunogenic for each of the 10 vaccine pneumococcal serotypes (postprimary, ≥92.7% of infants reached enzyme-linked immunosorbent assay antibody concentrations ≥ 0.2 μg/mL and postbooster, ≥97.6%) and for protein D, with a trend for lower postprimary geometric mean antibody concentrations and opsonophagocytic activity (OPA) titers in preterm infants for some pneumococcal serotypes. Postbooster, ≥91.9% of subjects in each group had an OPA titer ≥ 8 for each of the vaccine serotypes. Pneumococcal antibody concentrations and OPA titers after priming and booster vaccination were comparable between the 2 preterm groups. CONCLUSIONS: PHiD-CV was well tolerated and immunogenic in preterm infants when given as a 3-dose primary vaccination, with robust enzyme-linked immunosorbent assay antibody and OPA booster responses in the second year of life. Copyright © 2011 by the American Academy of Pediatrics.
Συγγραφείς:
Omeñaca, F.
Merino, J.M.
Tejedor, J.-C.
Constantopoulos, A.
Papaevangelou, V.
Kafetzis, D.
Tsirka, A.
Athanassiadou, F.
Anagnostakou, M.
François, N.
Borys, D.
Schuerman, L.
Περιοδικό:
PEDIATRIC INVESTIGATION
Λέξεις-κλειδιά:
bacterium antibody; diphtheria pertussis tetanus vaccine; Pneumococcus vaccine, anorexia; antibody blood level; antibody titer; application site erythema; application site pain; application site swelling; article; child; combination chemotherapy; controlled study; dose response; drowsiness; drug dose comparison; drug efficacy; drug fever; drug safety; drug tolerability; female; gestation period; human; immunization; immunogenicity; infant; irritability; major clinical study; male; outcome assessment; pneumococcal infection; prematurity; preschool child; priority journal; serotype; side effect, Female; Humans; Immunization, Secondary; Infant; Infant, Newborn; Infant, Premature; Male; Pneumococcal Infections; Pneumococcal Vaccines; Vaccination; Vaccines, Conjugate
DOI:
10.1542/peds.2010-1184
