Table 4.
Clinical trials of HEV vaccine [69]. This figure was used with permission from the publisher.
| Shrestha et al. NEJM–March 2007 [74] | Zhu et al. Lancet–August 2010 [77] | |
|---|---|---|
| Phase study | Phase II trial | Phase III trial |
| Type of study | Randomized, double-blind, placebo controlled | Randomized, double-blind, placebo controlled |
| Company | GlaxoSmithKline Biologicals | Xiamen Innovax Biotech |
| Country | Nepal | Jiangsu province, China |
| Recombinant protein ORF2 | Baculovirus expressed 56 kDa | E. coli expressed HEV 239 |
| Number of vaccines | 1794 healthy subjects | 112 604 healthy subjects |
| Randomization | HEV vaccine vs. placebo | HEV vs. HBV vaccine |
| Population | Mostly males (99.6%) Young (mean age 25 years) | Males and females, 16–65 years |
| HEV genotypes | Genotype 1 prevalent | Genotypes 1 and 4 prevalent with predominance |
| Doses | 20 µg | 30 µg |
| Route of administration | Intramuscularly | Intramuscularly |
| Intervals between doses | 0, 1, 6 months | 0, 1, 6 months |
| Primary end-point | Prevention of clinically overt HEV disease | Prevention of clinically overt HEV disease |
| Follow-up period | 2 years post-vaccination | 13 month post-vaccination |
| Efficacy | ||
| After 1st dose | 87.5% | 95.5% |
| After 2nd dose | 85.7% | 100% |
| After 3rd dose | 95.5% | 100% |
| Side effects Commercialization | Increased injection-site pain Not further developed | No side effects Hecolin® (Innovax) |