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The acellular pertussis (ADTP) vaccine booster may be more effective in young children who have previously been vaccinated with the ADTP vaccine than in those vaccinated with the whole-cell pertussis (WDTP) vaccine. Pertussis is a highly contagious infection of the upper respiratory tract that is also known as whooping cough. Among 139 children between 15 and 20 months old who received an ADTP booster, 109 had been vaccinated with the ADTP vaccine and 30 had been vaccinated with the WDTP vaccine as infants. Children in the ADTP group had higher levels of immunoglobulin G antibody after receiving the ADTP booster than those in the WDTP group. No significant difference in the incidence of adverse reactions was seen between the children who received the ADTP vaccine and those who received the WDTP vaccine during the first 14 days following treatment. None of the children developed a systemic reaction., The objective of this study was to evaluate reactogenicity and immunogenicity of the recently US-licensed Connaught/BIKEN (C/B) acellular DTP (ADTP) vaccine as a booster for children aged 15 to 20 months after they had received either the C/B ADTP or the US-licensed Connaught whole-cell DTP (WDTP) vaccine as infants. After infants had received either three doses of C/B ADTP (n = 109) or three doses of WDTP vaccine (n = 30) at 2, 4, and 6 months of age according to a 3:1, randomized, prospective design, they all received booster doses at 15 to 20 months of age with C/B ADTP. Fever >101 [degrees] F (38.3 [degrees] C), irritability, injection site redness [is greater than or equal to] 1 inch, injection site swelling, and injection site pain, among other reactions, were monitored for 14 days after vaccination. IgG antibody to pertussis toxin (PT) and filamentous hemagglutinin were analyzed by enzyme-linked immunosorbent assay and neutralizing antibody to PT was measured by Chinese hamster ovary (CHO) cell assay. No significant differences were observed between the WDTP- and ADTP-primed infants following their ADTP booster for any of the monitored reactions within 72 hours of vaccine administration or in the 4 to 14 days after vaccination. Prior to the ADTP booster, antibody levels were higher in children who had received ADTP compared with those who had received WDTP vaccine as infants for PT antibody as measured by enzyme-linked immunosorbent assay and CHO cell assay. Higher levels of IgG antibody following the ADTP booster were observed to filamentous hemagglutinin and to PT in ADTP-primed compared with WDTP-primed children. It is concluded that C/B ADTP boosters in 15- to 20-month-old children produced reactions that were not significantly different whether infants had been primed with WDTP or C/B ADTP. Antibody responses were enhanced after a C/B ADTP booster in C/B ADTP-primed compared with WDTP-primed infants. Pediatrics 1993; 91:756-760; acellular pertussis vaccine, whole-cell pertussis vaccine, diphtheria-tetanus toxoid-pertussis vaccine, immunogenicity, reactogenicity, pertussis toxin, filamentous hemagglutinin, immunization.

* 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, The two-component acellular pertussis (ADTP) vaccine may be more effective and safer than the US-licensed whole-cell diphtheria and tetanus toxoids and pertussis (WDTP) vaccine. These vaccines are given to infants to protect against diphtheria, tetanus and pertussis, or whooping cough. Eighty-eight (80%) of 110 infants were vaccinated with ADTP and 22 (20%) were vaccinated with WDTP at ages two, four and six months. Infants vaccinated with ADTP were less likely to develop a raised temperature or to experience moderate or severe pain at the site of the injection than were those vaccinated with WDTP. Blood levels of antibodies against whooping cough were higher after the third treatment in infants vaccinated with ADTP than in those vaccinated with WDTP. No difference in the blood levels of antibodies against diphtheria or tetanus was seen between the two groups of infants.

This is the first study in children from the United States that evaluates the immunogenicity of and adverse reactions to the Connaught/Biken two-component acellular pertussis vaccine compared with whole-cell pertussis vaccine when given as a primary immunization series at 2, 4, and 6 months of age. Three hundred eighty infants were studied; 285 received acellular diphtheria-tetanus toxoids-pertussis (DTP (ADTP) and 95 received whole-cell DTP (WDTP). Following the third dose, ADTP vaccination produced higher antibody responses than WDTP to lymphocytosis-promoting factor (enzyme-linked immunosorbent assay IgG geometric mean titer (GMT) = 131 vs 9 and Chinese hamster ovary cell assay GMT = 273 vs 16) and to filamentous hemagglutinin (IgG GMT = 73 vs 10) (all P < .0001). Agglutinin responses were higher in WDTP compared with ADTP recipients (GMT =50 vs 37; P = .02). Local reactions were fewer for all three doses following ADTP vaccination. Fever, irritability, drowsiness, anorexia, vomiting, and unusual crying all occurred less frequently in ADTP compared with WDTP recipients for one or more of the three doses. We conclude that his two-component ADTP vaccine when given as a primary series produces greater immunogenicity and fewer adverse effect than the currently licensed WDTP vaccine. Pediatrics 1992;89:882-887