Five-year antibody persistence in children after one dose of inactivated or live attenuated hepatitis A vaccine

Abstract

In China, both inactivated hepatitis A (HA) vaccine and live attenuated HA vaccine are available. We conducted a trial to evaluate 5-year immune persistence induced by one dose of inactivated or live attenuated HA vaccines in children. Subjects with no HA vaccination history had randomly received one dose of inactivated or live attenuated HA vaccine at 18-60 months of age. Anti-HAV antibody concentrations were measured before vaccination and at the first, second, and fifth year after vaccination. Suspected cases of hepatitis A were monitored during the study period. A total of 332 subjects were enrolled and 182 provided evaluable serum samples at all planned time points. seropositive rate at 5 y was 85.9% in the inactivated HA vaccine group and 90.7% in the live attenuated HA vaccine group. GMCs were 76.3% mIU/ml (95% CI: 61.7 - 94.4) and 66.8mIU/ml (95% CI: 57.8 - 77.3), respectively. No significant difference in antibody persistence between 2 groups was found. No clinical hepatitis A case was reported. A single dose of an inactivated or live attenuated HA vaccine at 18-60 months of age resulted in high HAV seropositive rate and anti-HAV antibody concentrations that lasted for at least 5 y.

Type A viral hepatitis: A summary and update on the molecular virology, epidemiology, pathogenesis and prevention

“…157 A similar one-dose strategy is now being evaluated in China using a single attenuated, live HAV vaccine. 158 Inactivated combined vaccines against hepatitis A and B, or hepatitis A and typhoid are available, mainly for travellers. 73,75,159 Cumulative experience based on the use of hundreds of millions of doses of inactivated hepatitis A vaccines indicate an excellent safety record, with acceptable reactogenicity and very rare vaccine related serious adverse events, irrespective of adjuvant, manufacturer or schedule.…”

“…157 The short and medium-range effectiveness of a single-dose immunisation strategy has been confirmed and shown to be independent of the use of an inactivated or live attenuated vaccine, or adjuvant type, in subsequent studies conducted in Nicaragua, 99 Korea, 178 India, 179 and China. 158 However, it remains to be seen whether a singledose immunisation policy will indeed provide long lasting protection against hepatitis A and whether a booster dose will be required eventually. Importantly, the anti-HAV (IgG) antibody geometric mean titre concentration at five years post vaccination was shown to be higher in patients receiving two vaccine doses, than in recipients of a single vaccine dose.…”

Hepatitis A vaccination and its immunological and epidemiological long-term effects – a review of the evidence

“…[74][75][76] Argentina was the first country to introduce single-dose UMV in toddlers in 2005. 77 Immunogenicity data for inactivated HAV vaccines (all in young children) have currently reached 10 years of follow-up evaluations in a first study, 43 and the single-dose results are looking promising, with seroprotection rates of 100% (10 year follow-up), 43 95.2% (7.5 years), 31 97.4% (6.3-9.2 years), 78 92.9% (4 years), 79 and 85.9% (5 years) 80 (Table 3). Statistical modeling with 10 years of follow-up data resulted in a 30-year seroprotection (≥3 mIU/mL) for 89% of children after singledose vaccination.…”

Hepatitis A vaccination

“…59 In another Chinese study, a similar persistence of anti-HAV postvaccination was detected between one-dose of HepA-L and one-dose of HepA-I among children, but the follow-up time was only 5 y postvaccination. 60 These studies indicate that immune protection after one dose of HepA might last for more than 10 y. Further studies should be conducted to clarify this hypothesis.…”