Published online April 3, 2006
PEDIATRICS Vol. 117 No. 4 April 2006, pp. 1084-1093 (doi:10.1542/peds.2005-1759)
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Pertussis (Whooping Cough)
Diphtheria
Tetanus (Lockjaw)

Acellular Pertussis Vaccine Booster Combined With Diphtheria and Tetanus Toxoids for Adolescents

Michael E. Pichichero, MDa, Mark M. Blatter, MDb, William A. Kennedy, MDc, James Hedrick, MDd, Dominique Descamps, MDe and Leonard R. Friedland, MDf

a University of Rochester Medical Center, Rochester, New York
b Primary Physicians Research, Pittsburgh, Pennsylvania
c University of California Los Angeles Center for Vaccine Research, Los Angeles Biomedical Research Institute at Harbor-University of California Los Angeles Medical Center, Torrance, California
d Kentucky Pediatric Research, Inc, Bardstown, Kentucky
e GlaxoSmithKline, Rixensart, Belgium
f GlaxoSmithKline, King of Prussia, Pennsylvania

BACKGROUND. The incidence of pertussis is increasing, especially in adolescents, attributed in part to waning of immunity after childhood immunization. Recently licensed in the United States for use in adolescents, acellular pertussis vaccines will provide an immunogenic and safe option for booster immunization against pertussis.

METHODS. This prospective, randomized, observer-blinded, multicenter, comparative study evaluated the safety and immunogenicity of a vaccine formulated with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis antigens (Tdap) compared with tetanus and diphtheria toxoids vaccine (Td) for booster immunization in adolescents. There were 4114 healthy adolescents aged 10 to 18 years who completed childhood vaccination against diphtheria, tetanus, and pertussis who were enrolled, randomized, and received study vaccine.

RESULTS. Local and general symptoms were comparable between the Tdap and Td groups. The immune response of Tdap was comparable with Td vaccine for tetanus and diphtheria seroprotection and booster responses. In addition, geometric mean concentrations of antibody to pertussis antigens, pertussis toxoid, filamentous hemagglutinin, and pertactin exceeded the antibody response elicited after infant immunization with diphtheria and tetanus toxoids and acellular pertussis antigens (DTaP) that had proven efficacy against pertussis.

CONCLUSIONS. In adolescents, the studied Tdap was safe and immunogenic and induced pertussis antibodies that were higher than those associated with efficacy in infants.

Key Words: pertussis • diphtheria • tetanus • vaccine • adolescents

Abbreviations: Tdap—tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine • DTaP—diphtheria and tetanus toxoids and acellular pertussis vaccine • DTP—diphtheria and tetanus toxoid and pertussis vaccine • Td—tetanus and diphtheria toxoids vaccine • Lf—limit of flocculation • PT—pertussis toxoid • FHA—filamentous hemagglutinin • PRN—pertactin • ELISA—enzyme-linked immunosorbent assay • EL.U.—enzyme-linked immunosorbent assay units • CI—confidence interval • ATP—according to protocol • GMC—geometric mean concentration • DTwP—diphtheria and tetanus toxoids and whole-cell pertussis vaccine

Accepted Sep 14, 2005.




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