Published online December 4, 2006
PEDIATRICS Vol. 119 No. 1 January 2007, pp. e179-e185 (doi:10.1542/peds.2005-2907)
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ARTICLE

Antipolyribosyl Ribitol Phosphate Response of Premature Infants to Primary and Booster Vaccination With a Combined Diphtheria-Tetanus-Acellular Pertussis-Hepatitis B-Inactivated Polio Virus/Haemophilus influenzae Type b Vaccine

Felix Omeñaca, MD, PhDa, José Garcia-Sicilia, MD, PhDb, Pilar García-Corbeira, MDc, Reyes Boceta, BPhc and Victorio Torres, MDb

a Departments of Neonatology
b Paediatrics, La Paz Hospital, Madrid, Spain
c Medical Department, GlaxoSmithKline, Tres Cantos, Madrid, Spain

BACKGROUND. Prematurity may be a risk factor for Haemophilus influenzae type b vaccine failure. This article evaluates the Haemophilus influenzae type b immunogenicity of a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus/Haemophilus influenzae type b vaccine in preterm infants (<37 weeks' gestation).

METHODS. This was an open-label, parallel group study. Preterm (N = 94) and term infants (N = 92) received 3 doses of a diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus/Haemophilus influenzae type b vaccine at 2, 4, and 6 months with a booster dose at 18 to 20 months. Antipolyribosyl ribitol phosphate antibody concentrations were determined in serum samples taken before and 1 month after primary and booster vaccination.

RESULTS. Postprimary seroprotection rates (antipolyribosyl ribitol phosphate ≥0.15 µg/mL) were lower in preterm than in term infants (92.5% vs 97.8%), with antipolyribosyl ribitol phosphate geometric mean concentrations of 2.241 vs 4.247 µg/mL. A progressive reduction in immune response to the Haemophilus influenzae type b antigen was observed with decreasing length of gestation and decreasing birth weight when cutoff ≥1 µg/mL was considered. Prebooster seroprotection rates and antipolyribosyl ribitol phosphate geometric mean concentrations were low in both groups (antipolyribosyl ribitol phosphate ≥1.0 µg/mL in 10.7% of preterm and 28.4% of term infants). A vigorous response to booster vaccination was seen in both groups, with no differences in postbooster seroprotection rates or antipolyribosyl ribitol phosphate geometric mean concentrations between the 2 groups (antipolyribosyl ribitol phosphate ≥1.0 µg/mL in 100% of preterm and 98.5% of term infants).

CONCLUSIONS. Primary vaccination with a hexavalent diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus/Haemophilus influenzae type b vaccine at 2, 4, and 6 months with a booster dose at 18 to 20 months elicits a satisfactory antipolyribosyl ribitol phosphate response in preterm infants compared with term controls. Immunologic response decreased with decreased gestational age and birth weight.

Key Words: Hib vaccines • PRP response • preterm infants • immunization • combined vaccines • DTaP-HBV-IPV/Hib vaccine

Abbreviations: Hib—Haemophilus influenzae type b • DTaP—diphtheria-tetanus-acellular pertussis • HBV—hepatitis B virus • IPV—inactivated poliovirus • PRP—polyribosyl ribitol phosphate • ATP—according-to-protocol • GMC—geometric mean concentration • CI—confidence interval

Accepted Jul 19, 2006.