This monocenter, descriptive, prospective, non-interventional study evaluated the long-term immune responses following routine vaccination with one or 2 doses of a licensed inactivated hepatitis A (HA) vaccine (Avaxim® 80U Pediatric) at age 11–23 months in a cohort of children from Mendoza, Argentina. Antibodies to hepatitis A virus (anti-HAV) were quantified annually up to Y5, and at Y7. Children whose titer decreased to below the seroprotection threshold (defined as an anti-HAV antibody concentration of ≥ 10 mIU/mL in a microparticle enzyme immunoassay up to Y5, or ≥ 3 mIU/mL in an electrochemiluminescence immunoassay at Y7) received a routine booster dose of the same HA vaccine. This report summarizes the data at 7 year after the first vaccination. Of 546 participants initially included, 264 participants remained at Y7 and provided blood samples. Of these, 204 having received one HA primary dose as a toddler were still seroprotected at Y7; titers for a further 7 also having received one HA dose as a toddler fell to below the seroprotection threshold and they therefore received a booster; all 53 having received 2 HA doses as a toddler and still present at Y7 remained seroprotected at Y7. One or 2 primary doses of this HA vaccine in toddlers result in very good persistence of anti-HAV up to 7 year post-first vaccination.

SUMMARY. 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.