Table 1.

Safety, immunogenicity, and efficacy conferred by vaccination with Hecolin^® during a large-scale clinical trial

Property	Performance	Ref.
Safety	In healthy adults: • Most adverse events were mild; vaccine-related serious AEs had not been observed • Rates of solicited local AEs were higher in the vaccine group than in the placebo group (13 vs. 7 %) and the rates of solicited systemic AEs were not significantly different between the two groups (20 vs. 20 %) • Reported AE of the entire immunized population was <2 % of both vaccine and placebo groups In pregnant women: • Appeared to be safe for mothers and fetus	[5, 53]
Immunogenicity	Robust humoral response—Hecolin® induced, almost completely seroconversion, and reached sevenfold higher level of anti-HEV IgG (15 Wu/ml) than immunity induced by asymptomatic infection (1.9 Wu/ml)	[28]
Efficacy	100 % (72–100) against hepatitis E disease; 78 % (66–86) against HEV infection; 100 % (9–100) against hepatitis E disease after receiving two shots in 1 month	[28, 53]

AE adverse event