Comparison of a Three-Component Acellular Pertussis Vaccine With a Whole-Cell Pertussis Vaccine in 15- Through 20-Month-Old Infants

Autor: Keith S. Reisinger, Hal Rathfon, M E Fontana, Sarah S. Long, Edward P. Rothstein, O Crayne, Mark M. Blatter, J M Jacobs, Allan Arbeter, Henry H. Bernstein
Rok vydání: 1994
Předmět:
Zdroj: Pediatrics. 93:656-659
ISSN: 1098-4275
0031-4005
DOI: 10.1542/peds.93.4.656
Popis: Objective. To compare the immunogenicity and reactogenicity of a diphtheria and tetanus toxoids and three-component acellular pertussis vaccine (DTaP) with a diphtheria and tetanus toxoids and whole-cell pertussis vaccine (DTwP) when administered as a booster dose to infants 15 through 20 months of age. Design. Randomized, double-blind, comparative study. Setting. Three pediatric practices (two private; one hospital-based). Participants. One hundred and sixty-five healthy 15-through 20-month old infants. Selection procedures and interventions. Infants were randomly assigned in a 2:1 ratio to receive vaccine from a single lot of DTaP or from commercially available DTwP. DTaP contained 25 µg of pertussis toxoid, 25 µg of filamentous hemagglutinin, 8 µg of pertactin (69-kilodalton outer membrane protein), 25 flocculating units of diphtheria toxoid, and 10 flocculating units of tetanus toxoid per 0.5-mL dose. DTwP contained one half the concentrations of diphtheria and tetanus toxoids compared with DTaP and a pertussis component with a potency of 4 U/0.5-mL dose. Serum samples were obtained on the day of immunization and 4 weeks later. Adverse reactions were recorded by parents for 7 days after immunization. An interval history was obtained 4 weeks after immunization. Measurements and results. IgG antibody to pertussis toxoid, filamentous hemagglutinin, pertactin, diphtheria toxoid, and tetanus toxoid was measured by an indirect enzyme-linked immunosorbent assay (ELISA) method. One month after immunization, the geometric mean antibody levels after DTaP compared with DTwP were: pertussis toxoid, 70.6 vs 28 ELISA U/mL (P = .003); filamentous hemagglutinin, 183.4 vs 43 ELISA U/mL (P < .001); pertactin, 216 vs 49.9 ELISA U/mL (P < .001); diphtheria, 14.1 vs 14.9 IU/mL (P = .74); and tetanus, 11.9 vs 14.8 IU/mL (P = .089). After immunization with DTaP, most local and systemic adverse experiences were significantly fewer compared with DTwP (P < .05). Conclusions. This three-component DTaP vaccine demonstrates significantly greater immune responses to pertussis toxoid, filamentous hemagglutinin, and pertactin, equivalent immune responses to diphtheria and tetanus toxoids, and significantly less reactogenicity compared with a licensed DTwP.
Databáze: OpenAIRE
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