Hepatitis E Hecolin (HEV-239) Vaccine Clinical Study Launched in the USA

A Hepatitis E Virus vaccine Hecolin (HEV-239) launched a limited phase 1 clinical trial in the USA, with the first 2 of 25 total volunteers being vaccinated on May 1, 2019. 

It is the first time that the Food and Drug Administration (FDA) has approved the Chinese vaccine, Hecolin, to enter a clinical trial in the United States, according to Zhang Jun, deputy director of National Institute of Diagnostics and Vaccine Development in Infectious Diseases at Xiamen University.   

Hecolin is the only commercially approved Hepatitis E vaccine available today. 

Xiamen Innovax Biotech Co., Ltd. (INNOVAX) was notified by US National Institutes of Health (NIH) that its Investigational New Drug (IND) application of Hecolin (HEV-239) at FDA became effective on January 12, 2019. 

Hecolin has been used in China since 2012 for the prevention of hepatitis E. Hecolin was initially developed at Xiamen University and then transferred to and commercialized by the Xiamen Innovax Biotech Co., Ltd. 

According to Xiamen University, this double-blind, randomized, placebo-controlled study of Hepatitis E virus (HEV) will assess the safety, reactogenicity, and immunogenicity of the Hecolin (HEV-239) vaccine. 

This study’s primary objectives are to: 

• assess the safety and reactogenicity of HEV-239 following delivery of each vaccine dose. The study subjects will receive 3 doses of study product on Days 1, 29, and 180, and will remain in the study for up to 13 months. The study duration will be approximately 15 months, and 
• assess the number of subjects with > / = 4 fold rise in HEV immunoglobulin G (IgG) at any time after vaccination

Hepatitis E is a liver disease caused by HEV, which is transmitted mainly through contaminated drinking water and food. Large outbreaks of the disease have been reported in at least 30 countries in Africa, Asia, and North America.

According to a World Health Organization (WHO), there are approximately 20 million HEV infections, 3.4 million symptomatic cases and 70,000 deaths globally every year.

The disease is typically most life-threatening among pregnant women, with a fatality rate of 10 percent to 50 percent. 

People with pre-existing chronic liver disease are prone to develop severe hepatitis following HEV infection. 

The trial is sponsored by the National Institute of Allergy and Infectious Diseases, and patient recruiting is the responsibility of Emory Children's Center, located in Atlanta, Georgia.