Comparison of a diphtheria and tetanus toxoids and bicomponent acellular pertussis vaccine with diphtheria and tetanus toxoids and whole-cell pertussis vaccine in infants

M. E. Pichichero, A. B. Francis, S. M. Marsocci, J. L. Green and F. A. Disney
Department of Pediatrics, University of Rochester Medical Center, NY 14642.

OBJECTIVE--To compare the reactogenicity and immunogenicity of a diphtheria and tetanus toxoids and two-component acellular pertussis (ADTP) vaccine with a US-licensed whole-cell (WDTP) vaccine. SETTING--General pediatric practice in suburban Rochester, NY. DESIGN--Prospective, double-blind, randomized study. PARTICIPANTS--One hundred ten infants were studied; 88 (80%) received ADTP and 22 (20%) received WDTP at ages 2, 4, and 6 months. INTERVENTION--Vaccination. MEASUREMENTS/MAIN RESULTS--Temperature of 38.3 degrees C or higher (P = .03) and moderate or severe injection-site pain (P = .02) occurred less frequently in infants receiving ADTP than those receiving WDTP for the combined three doses. Following the third dose, ADTP vaccination produced higher antibody responses than WDTP to pertussis toxin (geometric mean enzyme-linked immunosorbent assay IgG was 52.2 vs 12.5; P < .001) and to filamentous hemagglutinin (geometric mean IgG was 182.8 vs 3.5; P < .001). No interference in the diphtheria or tetanus antibody responses was observed in recipients of the ADTP vaccine. CONCLUSIONS--This two-component ADTP vaccine, when given as a primary infant series, produces fewer adverse effects and greater immunogenicity to the two pertussis components that it contains than US-licensed WDTP vaccine.