Infection with Hepatitis E virus causes acute sporadic and epidemic viral hepatitis. Symptomatic HEV infection is most common in adults aged 15-40 years. Although HEV infection is frequent in children, the course of the infection is mostly asymptomatic and anicteric. 

Peak viremia and shedding of HEV into the faeces occurs during the incubation period and early acute phase of disease (1-3 weeks). 

The clinical presentation of hepatitis E is comparable to hepatitis A and other similar enterically – transmitted infections. Occasionally, a severe form of hepatitis develops, with mortality rates ranging between 0.5% - 4.0% in the overall population of patients. 

This severe form of hepatitis may reach a mortality rate of 20% during pregnancy in the 3rd trimester or cause fetal death or abortion. In disease-endemic areas, the early diagnosis is important for the establishment of the disease state and for providing efficient treatment.

In China, major waterborne epidemics of hepatitis E have occurred in Xinjiang between 1986-1988 with estimated cases of more than 120,000 infected and 707 dead (among them 404 pregnant women). 

Since then, outbreaks have been reported from Beijing, Tianjin, Jiling, Liaolin, Shandong and Jiangsu. In 1992, massive seroprevalence studies were carried out to estimate the prevalence of the disease in China. 

These studies covered 13 municipal sites with more than 30,000 samples tested for presence of antibodies to HEV. The observed antibody prevalence was 17.2%. In 2003, the Chinese Health Ministry reported that from 7 major pathogens infecting the gastroenterol tract, the incidents with HEV have increased with 43% compare to the previous year with decrease of othergastroenterol diseases. 

Thus, HEV is a significant health-threatening problem with high prevalence in China.         

                                                  

Recent seroprevalence studies indicated a high prevalence of HEV infection among the healthy populations in some industrial countries with historically low occurrence of Hepatitis E including the US, Japan and Europe. 

These studies list hepatitis E among the significant health-threatening problems worldwide and the increasing public health concern has lead to the development of HEV vaccines and antibody detection methods. 

The recombinant antigen was cloned from HEV genotype-I which is the most common one in China.

Self-aggregated into virus like particle (VLP) after purification.

And strong immunity to the other HEV genotypes was observed after vaccine innoculation.

E.coil expressed, non-fusion 240 amino acids length fragment of HEV capsid protein (ORF2). E. Coli is the most safest vector system, which has been proved by a lot of application among the population. The only competitor - recombinant HEV vaccine from GSK used baculovirus-infected insect cells as vector whose safety is not confirmed till now.

Immunogenic response ED50 <0.25 micrograms (mouse) and seroprotection for Hepatitis E (protective efficacy).

83% protection against developing of clinical symptoms after contact with the virus - 100%

The recombinant HEV antigen exists mainly in a way of Virus-like Particles (VLPs) that can simulate major neutralized epitopes of native HEV. It's a rather good antigen that can stimulate the body to produce high-titre neutralized antibodies.

Full compliance with international standards (FDA, Europe) for safety related issues.

Estimated market potential: The World Health Organization estimates HEV as being present globally in the range of 2.5% to 3.0%. It has been also estimated, that hepatitis E virus is likely to become the number one cause of hepatitis among travelers.

Purity >95%.

Alum adjuvant, 20 ug/dose.

Suggested immunized program: 0,1m, 6m.

Our achievements are original and highly exclusive. The applications for four patents were submitted which covering the major technical core of the highly reactive recombinant antigen. Patent for the ORF(E2) antigen, its epitopes and monoclonal antibodies has been filled in the following countries under PCT (or Patent Cooperation Treaty)- Japan, India, Mexico,US,Europe,Brazil, etc.