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HEV Vaccine

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		HEV Vaccine

Hepatitis E virus (HEV) causes a form of acute viral hepatitis that is transmitted through contaminated water or food with an overall mortality rate of 1% to 2% among adults in the developing world. HEV is a public health concern, especially in pregnant women infected in their third trimester where the maternal mortality rate can be as high as 20%. There is neither a specific treatment nor an available vaccine for the prevention of HEV.

HEV was first isolated and cloned by Genelabs scientists working in conjunction with researchers from the U.S. Centers for Disease Control and Prevention. U.S. patents that broadly claim HEV genomes, DNA fragments and their encoded proteins have issued to Genelabs.

Genelabs has granted an exclusive worldwide license to GlaxoSmithKline (GSK) for vaccine applications under Genelabs' HEV patent portfolio. Based on clinical trial results for GSK’s investigational vaccine against HEV, Genelabs received a milestone payment in November 2004. In December 2005, results of the clinical trial were presented publicly for the first time. Among the participants that received the full three-dose schedule of vaccines, the study demonstrated that the HEV vaccine was 96% effective, with 3 cases of HEV in the 898 subjects who received the vaccine, and 66 cases of HEV in the 896 subjects who received placebo. The vaccine was also shown to be well tolerated, with no significant adverse safety events attributed to the vaccine during the course of the study.

HEV Vaccine Clinical Trial Program

Two Phase I trials have been completed - one in the U.S. and one in Nepal - enrolling 88 and 44 volunteers respectively. Both of these trials demonstrated that the investigational HEV vaccine appeared to be safe at various doses to normal human volunteers and generated an antibody response to the vaccine antigen.

A Phase II clinical trial has been conducted by the Walter Reed Army Institute of Research (“WRAIR”) in collaboration with the Medical Department of the Royal Nepal Army, the U.S. National Institutes of Health and GlaxoSmithKline Biologicals under a U.S. Investigational New Drug (“IND”) exemption. Approximately 2,000 adult volunteers were enrolled, the majority of which received three doses of either HEV vaccine or placebo. The study was conducted in Nepal, where HEV causes annual epidemic outbreaks and has an historical attack rate that is among the highest in the world.

The results of this study, called Study HEV003, were presented by representatives of WRAIR at the American Society of Tropical Medicine and Hygiene's 54th Annual Meeting in December 2005. Genelabs Technologies, Inc. ("Genelabs") did not participate in Study HEV003 or the presentation of the data at the meeting. The Study HEV003 results presented by WRAIR indicated that in the clinical trial, the investigational vaccine was 96% effective in preventing disease caused by HEV, with a total of 69 confirmed cases of hepatitis E occurring among individuals who had received all three doses of the investigational HEV vaccine or the placebo. Of these cases, 66 occurred among placebo recipients and 3 occurred among vaccine recipients. In addition, the data presented indicated that the vaccine was well tolerated, with no significant adverse safety events attributed to the vaccine during the course of the study.