ABSTRACT
An acellular pertussis vaccine (DTaP) containing pertussis toxoid, filamentous hemagglutinin and the 69-kDa outer membrane protein (pertactin) was compared with United States-licensed whole cell pertussis vaccine (DTwP) as a three dose sequence at 2, 4 and 6 months of age. Eighty infants were enrolled; 62 received DTaP and 18 received DTwP. Sixty-two infants had preimmunization and 1 month postimmunization sera available for pertussis antibodies. No infant experienced a serious adverse reaction. Significantly fewer infants in the DTaP group experienced irritability (P < 0.001) and moderate to severe injection site pain and redness (P < 0.001, and P = 0.03, respectively). The DTaP group also had significantly greater increases in geometric mean titers of antibodies against filamentous hemagglutinin (P < 0.001) and pertactin (P = 0.006). This three-component DTaP vaccine induced an antibody response to pertussis toxin, filamentous hemagglutinin and pertactin but caused fewer adverse reactions than DTwP when administered as a primary series of immunization to 2-month-old infants.
Subject(s)
Antibodies, Bacterial/biosynthesis , Bacterial Outer Membrane Proteins/immunology , Bordetella pertussis/immunology , Hemagglutinins/immunology , Pertussis Vaccine/immunology , Toxoids/immunology , Virulence Factors, Bordetella , Bacterial Outer Membrane Proteins/administration & dosage , Double-Blind Method , Female , Hemagglutinins/administration & dosage , Humans , Infant , Infant, Newborn , Injections, Intramuscular , Male , Pertussis Vaccine/adverse effects , Toxoids/administration & dosageSubject(s)
Pharyngitis/diagnosis , Streptococcal Infections/diagnosis , Streptococcus pyogenes , Tonsillitis/diagnosis , Antigens, Bacterial/analysis , Child , Child, Preschool , False Negative Reactions , False Positive Reactions , Humans , Latex Fixation Tests , Microbial Sensitivity Tests , Penicillins/therapeutic use , Pharyngitis/microbiology , Pharynx/microbiology , Risk , Streptococcus pyogenes/immunology , Streptococcus pyogenes/isolation & purification , Tonsillitis/microbiologyABSTRACT
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 micrograms 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, 362 vs 104 ELISA U/mL; IgG lymphocytosis promoting factor, 408 vs 81 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 [corrected].
