A 2+1 pertussis vaccination schedule administering DTPa-IPV-HBV/Hib at 6-weeks, 12-weeks, and 12-months of age may maximise early protection and improve antibody persistence into the second year of life. This may be equivalent to the current 3+1 schedule where DTPa-IPV-HBV/Hib is administered at 2, 4, 6 and 18 months. Both schedules include DTPa-IPV boosting at 4-years. We aimed to evaluate the 2+1 schedule in Australia.
Serum was collected pre- and 1-month post-primary and booster vaccinations; and during the second year of life from 82 infants. IgG- geometric mean concentrations (GMC) to pertussis-toxin (PT), pertactin (PRN), filamentous-hemagglutinin (FHA), tetanus-toxin (TT) and diphtheria-toxoid (DT) were measured using a DTPa-multiplexed bead-based immunoassay.
The 2+1 schedule was well tolerated and immunogenic with increasing DTPa-IgG-GMC observed after each subsequent dose, except for TT for which levels remained unchanged between the first two doses.
Post-hoc analyses showed that high baseline antibody titres in infants pre-vaccination (i.e. maternally-derived) influenced immunogenicity of subsequent infant vaccines. GEE modelling of infant PT antibody responses across the first 4 years of life based on serostatus at baseline showed an average reduction in PT-IgG by 40% (p=6.6e-05). However, all children responded well to the 4-year booster, achieving antibody levels associated with seropositivity/sero-protection for all DTPa antigens.
Comparing the 2+1 schedule to a historical control cohort vaccinated with a 3+1 schedule showed that after three doses, DTPa-IgG concentrations were higher in the 2+1 group, except for FHA-IgG. During the second year of life, PT, PRN and FHA-IgG antibodies remained higher in 2+1 compared to 3+1 vaccinated infants. By 4-years of age, similar DTPa-IgG concentrations were observed between groups for all antigens. Responses to a 4-year booster were comparable between schedules, except DT-IgG was higher in the 2+1 group. All children were seroprotected throughout the study (TT- and DT-IgG≥0.01IU/mL).
These results suggest a 2+1 DTPa-schedule provides immunity into the second year of life and may induce comparable protection to the current 3+1 schedule. Given the impact of maternal antibody on infant responses, future studies should determine the optimal 2+1 schedule based on current recommendations for repeated maternal pertussis immunisation.