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Published online March 20, 2006
PEDIATRICS Vol. 117 No. 4 April 2006, pp. e717-e724 (doi:10.1542/peds.2005-0348)
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Haemophilus influenzae Type b Immunization in Infants in the United Kingdom: Effects of Diphtheria/Tetanus/Acellular Pertussis/Hib Combination Vaccine, Significant Prematurity, and a Fourth Dose

Janet E. Berrington, MDa, Andrew J. Cant, MDb, John N.S. Matthews, PhDc, Marilyn O'Keeffe, PhDc, Gavin P. Spickett, DPhil, FRCPd, Alan C. Fenton, MDa

a Department of Neonatology, Royal Victoria Infirmary, Newcastle Upon Tyne, England
b Department of Paediatric Immunology and Infectious Diseases, Newcastle General Hospital, Newcastle Upon Tyne, England
c School of Mathematics and Statistics, University of Newcastle Upon Tyne, Newcastle Upon Tyne, England
d Department of Immunology, Royal Victoria Infirmary, Newcastle upon Tyne, England

OBJECTIVE. To measure anti-polyribosylribitolphosphate (PRP) antibody and anti–tetanus toxoid (TT) antibody responses in UK infants to explore the effects of (1) immunization with an acellular diphtheria/tetanus/pertussis/Haemophilus influenzae type b (DTPHib) combination vaccine, (2) significant preterm delivery, and (3) a fourth dose of conjugated Hib vaccine (PRP-T) in those with a low anti-PRP antibody (<1.0 µg/mL) after primary immunization.

METHODS. A prospective study was conducted in 4 tertiary neonatal units at a time when 2 types of DTPHib vaccines were used interchangeably in the United Kingdom for primary immunization: acellular (DTPaHib) and whole cell. Timing and type of all vaccine doses were as per standard UK practice. Blood was taken before and after immunization. A total of 166 preterm and 45 term infants completed the study; 97 (15 term) infants who had anti-PRP antibody <1.0 µg/mL were offered a fourth dose of PRP-T; 61 (55 preterm) then had repeat antibody measurements. Anti-PRP and anti-TT antibody after primary immunization relative to gestation and number of whole cell vaccine doses received was measured, as well as anti-PRP antibody after a fourth dose of PRP-T.

RESULTS. A total of 49% of preterm and 33% of term infants had anti-PRP antibody <1.0 µg/mL after full primary immunization. Receipt of 1 or more acellular vaccine doses was associated with lower anti-PRP antibody, a dose response effect being observed. Preterm infants were less likely to have anti-PRP antibody >1.0 µg/mL compared with term infants. A total of 93% of infants who were given a fourth dose had anti-PRP antibody >1.0 µg/mL. Anti-TT antibody responses were satisfactory for all infants but also reduced by each DTPaHib dose received.

CONCLUSION. Infants who receive DTPaHib, are significantly preterm, or who do not receive a fourth dose of conjugated Hib vaccine may be at increased risk for Hib disease.

Key Words: Haemophilus influenzae type b • immunization • preterm • acellular • booster

Abbreviations: Hib—Haemophilus influenzae type b • PRP-T—polyribosylribitolphosphate-tetanus conjugate • DTPw—diphtheria/tetanus/whole-cell pertussis • DTPwHib—diphtheria/tetanus/whole-cell pertussis/Haemophilus influenzae type b • Men C—Neisseria meningitidis serotype C • DTPaHib—diphtheria/tetanus/acellular pertussis/Haemophilus influenzae type b • GMT—geometric mean titer • EIA—enzyme immunoassay • TT—tetanus toxoid • DTPHib—diphtheria/tetanus/pertussis/Haemophilus influenzae type b • GSK—GlaxoSmithKline • CI—confidence interval • RIA—radioimmunoassay

Accepted Sep 13, 2005.


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