We compared the reactions and immunogenicity of DT acellular
pertussis (
DTaP) vaccines containing
pertussis toxoid (PT) and filamentous haemagglutinin (FHA) (2-component DTaP) or PT, FHA and
pertactin (PRN) (3-component
DTaP vaccine) with a whole cell (
DTwP) vaccine as a fourth-dose booster in 158 children (15-20 months old) who had received 3 primary
vaccine doses with the same
vaccines at 2, 4 and 6 months of age. Randomization was 3:1 for DTaP:DTwP and all children received concomitant oral
polio vaccine (OPV).
Fever (> 38 degrees C), irritability, local injection site
erythema (> 10 mm), swelling (> 10 mm), and
pain (moderate or more) were assessed for 72 h after booster vaccination. DTwP vaccinees had a higher incidence of
fever (29.4%) and injection-site
pain (45.7%) than 3-component DTaP vaccinees (
fever, 9.6%, p < 0.02; injection-site
pain, 3.8%, p < 0.01); 2-component DTaP vaccinees had less injection-site
pain (8.3%, p < 0.01). Pre- and post-vaccination
immunoglobulin G (
IgG) antibody was measured by
enzyme-linked
immunosorbent assay (ELISA). Pre- and post anti-PT levels were similar for all 3
vaccine groups. Anti-FHA antibody was higher pre- and post-vaccination for both
DTaP vaccine groups compared with the DTwP vaccinees (p < 0.01 for all comparisons). For 3-component DTaP vaccinees, anti-PRN antibody was higher pre- and post-vaccination compared to DTwP vaccinees (p < 0.01 for both comparisons).
Tetanus antibody was higher pre- and post-vaccination for DTwP versus both
DTaP vaccine groups, and
diphtheria antibody was similar pre- and post-vaccination for all 3 groups. These 2- and 3-component
DTaP vaccines produce less common reactions and comparable or higher antibody to the components they contain (except
tetanus) than
DTwP vaccine when given as a booster to 15- to 20-month-old children previously primed with the same
vaccine.