Long-term efficacy of a recombinant hepatitis E vaccine in adults: 10-year results from a randomised, double-blind, placebo-controlled, phase 3 trial
In Chinese RCT (n=112,604 healthy adults age 16-65 years), vaccine efficacy was 86.6% (95%CI 73.0-94.1) over 10-years (90 and 13 people developed hepatitis E in vaccine & placebo group, respectively). Vaccine-induced antibodies against hepatitis E virus persisted for ≥8.5 years.
Source:
The Lancet
SPS commentary:
A related commentary notes that hepatitis E virus (HEV) is the main cause of acute viral hepatitis worldwide. It discusses the results of the study and notes that the Wantai HEV IgG assay was used, for which a limit of detection of 0.077 WHO units/mL was determined. The limit of detection observed with the Wantai HEV assay in different European countries is around 0.25-0.30 WHO units/mL, thus questioning how many vaccinated people would remain HEV IgG positive after 10 years if using the higher threshold.