ObjectivesThis study aimed to evaluate the immunogenicity and safety of a hepatitis E (HE) vaccine using an accelerated vaccination schedule (vaccine doses at 0, 7 and 21 days). MethodsA total of 126 participants aged ≥18 years were randomly assigned to receive the hepatitis E virus vaccine in either the accelerated group (0, 7 and 21 days) or the routine group (0, 1 and 6 months). Serology samples were obtained at 0, 21, 28 and 51 days, and 7 months in the accelerated group, or 0, 1, 2 and 7 months in the routine group after the first vaccine injection. Adverse events (AEs) reported during the whole study were analysed. ResultsA total of 126 participants were randomized, 63 for each group. Sixty-two participants in the accelerated group and 63 in the routine group received at least one dose of vaccine; 57 and 63 participants received all three doses and were included in per-protocol set, respectively. In the per-protocol population, at 1 month after the last dose (accelerated group at 51 days versus routine group at 7 months), the seropositive rates were both 100% (57/57 and 63/63, respectively), and the geometric mean concentrations (GMCs) were 8.51 WHO units/mL (95% CI 6.73–10.76) in the accelerated group and 9.67 WHO units/mL (95% CI 7.67–12.20) in the routine group. The ratio of the accelerated group GMC to the routine group GMC was 0.88 (95% CI 0.61–2.17, lower limit of 95% CI > 0.5), indicating that the accelerated vaccination schedule was non-inferior to the routine one. The overall incidence rates of solicited AEs in the accelerated and routine groups were 32.26% (20/62) and 30.16% (19/63), respectively (p 0.800). Most AEs were moderate. ConclusionsAn accelerated schedule is safe and provides protective antibodies in a shorter time compared with the routine schedule. The accelerated schedule should be recommended to adults who are travelling on short notice to an HE-endemic area or during an HE outbreak (Clinical Trial Registration. NCT03168412)
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