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May 1992

Clinical Reactions and Immunogenicity of the BIKEN Acellular Diphtheria and Tetanus Toxoids and Pertussis Vaccine in 4- Through 6-Year-Old US Children

Author Affiliations

From Pennridge Pediatrics (Sellersville), Temple University School of Medicine (Philadelphia), and St Christopher's Hospital for Children, Philadelphia, Pa (Drs Bernstein, Rothstein, Schiller, Girone, Hipp, Souder, and Kennedy), Elmwood Pediatrics (Rochester) and the University of Rochester (NY) School of Medicine (Drs Pichichero, Francis, Disney, Green, Marsocci, Lynd, and Wood), the Medical College of Pennsylvania and Allegheny General Hospital, Pittsburgh (Dr Kovel), and Connaught Laboratories, Swiftwater, Pa (Dr Meschievitz).

Am J Dis Child. 1992;146(5):556-559. doi:10.1001/archpedi.1992.02160170036012

• Objective.  —To compare the immunogenicity and reactogenicity of a two-component acellular pertussis vaccine with a whole-cell diphtheria and tetanus toxoids and pertussis vaccine (W-DTP) when administered as a booster to children 4 through 6 years of age.

Design.  —This was a randomized, double-blind study.

Setting.  —Children in this study were from three general pediatric practices (two were private, one was university-affiliated).

Participants.  —Three hundred and sixteen 4- through 6-year-old children who had received four previous W-DTP immunizations at the recommended times were studied.

Selection Procedures and Interventions.  —Children were randomly assigned in a 1:3 ratio to receive either W-DTP or one of three lots of acellular diphtheria and tetanus toxoids and pertussis vaccine (A-DTP). The A-DTPs contained 3.75 μg each of lymphocytosis promoting factor and filamentous hemagglutinin protein nitrogen per 0.5 mL and the same concentrations of diphtheria and tetanus toxoids as W-DTP. Serum samples were obtained on the day of immunization and 4 to 6 weeks later. Adverse reactions were recorded by parents at 6, 24, 48, and 72 hours.

Measurements and Results.  —An indirect enzyme-linked immunosorbent assay (ELISA) method determined IgG antibody response to lymphocytosis promoting factor, filamentous hemagglutinin, and tetanus toxoid; a CHO cell assay measured neutralizing antibodies to pertussis toxin; and serum neutralization on VERO cells assayed diphtheria antitoxin. One month after booster doses were administered, the geometric mean antibody levels for A-DTP vs W-DTP were IgG filamentous hemagglutinin, 408 vs 81 ELISA U/mL; IgG lymphocytosis promoting factor, 362 vs 104 ELISA U/mL; CHO cell, 210 vs 107; diphtheria, 21.7 vs 12.1 U/mL;, and tetanus, 2.86 vs 2.04 Eq/mL. Following immunization with A-DTP, local and systemic adverse experiences were 30% to 50% and 20% to 30% fewer, respectively, as compared with W-DTP.

Conclusions.  —The BIKEN A-DTP vaccine used in this study demonstrates enhanced immunogenicity to lymphocytosis promoting factor, filamentous hemagglutinin, and other measured antigens and less reactogenicity compared with licensed W-DTP.(AJDC. 1992;146:556-559)