Five-year follow-up of immune response after one or two doses of inactivated hepatitis A vaccine given at 1 year of age in the Mendoza Province of Argentina

Our study was conducted to further investigate the single-dose approach of hepatitis A vaccination, while providing supportive data on the flexibility of booster administration. Participants received at least one dose of Avaxim 80U Pediatric at 11-23 months of age, and they will be followed for 10 years. We report here the fourth and fifth years after the first vaccination. Group assignment was based on whether the children received 1 dose and no booster during the study (Group 1) or 2 doses and no further booster (Group 2). Anti-HAV antibody concentrations were assessed at each annual visit. Of the 546 initial participants, 441 (80.8%) and 412 (75.5%) were followed up 4 and 5 years after vaccination, respectively. Of the 411 subjects evaluable at Year 5, 318 had received one vaccine dose and 85 had received two. Seroprotection rates were still high in Group 1 (99.7%) and in Group 2 (100%) 5 years after one or two doses of Avaxim 80U Pediatric, correspondingly. Anti-HAV geometric mean concentrations decreased in both groups compared to what they were 3 years after vaccination, while remaining well above the 10 mIU/mL threshold 5 years after vaccination. The highest concentrations were found in the children who received 2 vaccine doses. Hepatitis A humoral immunity induced by a single dose of inactivated hepatitis A vaccine can persist for at least 5 years in a paediatric population. The study results also support recommendations in favour of a flexible time window for booster vaccination.