Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）

Phase 4 Completed 601 enrolled Jun Zhang Xiamen Center for Disease Control and Prevention · collab Xiamen Innovax Biotech Co., Ltd · collab

Non-randomizedSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to determine the safety and immunogenicity of the recombinant hepatitis E vaccine in people older than 65 years, and evaluate the efficacy of hepatitis E vaccine in this population.

Timeline

Start: 2014-06
Primary completion: 2015-12-07
Completion: 2015-12-07

Publications

Background Zhu FC, Zhang J, Zhang XF, Zhou C, Wang ZZ, Huang SJ, Wang H, Yang CL, Jiang HM, Cai JP, Wang YJ, Ai X, Hu YM, Tang Q, Yao X, Yan Q, Xian YL, Wu T, Li YM, Miao J, Ng MH, Shih JW, Xia NS. Efficacy and safety of a recombinant hepatitis E vaccine in healthy adults: a large-scale, randomised, double-blind placebo-controlled, phase 3 trial. Lancet. 2010 Sep 11;376(9744):895-902. doi: 10.1016/S0140-6736(10)61030-6. Epub 2010 Aug 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HEV239	Vaccine	30 ug	—

Phase Ⅳ Clinical Trial of Recombinant Hepatitis E Vaccine（Hecolin®）

Summary

Timeline

Publications

Drugs

Indications