Study Published In New England Journal Of Medicine: Vaccine 95.5% Effective Against Neglected Hepatitis E

Main Category: Liver Disease / Hepatitis
Also Included In: Immune System / Vaccines;  Clinical Trials / Drug Trials
Article Date: 12 Mar 2007 - 0:00 PDT

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A new candidate vaccine against hepatitis E, developed collaboratively by GlaxoSmithKline (GSK) and the Walter Reed Army Institute of Research (WRAIR), was found to be 95.5% effective in a Phase Two trial, according to a study to be published in the New England Journal of Medicine. Hepatitis E, a waterborne strain of hepatitis that occurs almost exclusively in the developing world, is currently without cure or medical prophylaxis.

Three doses were administered over six months. After the third dose and over a follow-up period of approximately 20 months, there was a 7% attack rate in those in the placebo group and a 0.3% rate in those who had received the vaccine. The trial's results also show that the vaccine was well-tolerated, with a safety profile similar to placebo, except for increased pain at the injection site; the most common adverse reaction besides injection site pain was mild to moderate headache after vaccination.

"This research represents a major breakthrough against hepatitis," said Dr. Bruce Innis, a co-author of the study and Vice President, Clinical Research and Development, GSK Biologicals, the vaccine division of GSK. "Hepatitis E is among the most common causes of jaundice in the developing world and its large, frequent outbreaks have devastating consequences. Today's news that an effective vaccine may have been found means it's time to put the disease on the global agenda and begin thinking about immunization strategies."

"This project extends GSK's long-standing commitment to hepatitis and builds upon our introduction of the world's first recombinant hepatitis B vaccine as well as the first hepatitis A vaccine," added W. Ripley Ballou, Vice President, Emerging Diseases, Clinical Research and Development, GSK Biologicals. "This breakthrough reflects the hard work and expertise of our long-time collaborators in hepatitis research. We are actively working to identify new partners to complete the vaccine's development."

GSK will actively look to partner with the public sector to continue the vaccine's development, in keeping with its tradition of public-private partnerships for vaccines addressing the diseases of the developing world, such as malaria, TB and HIV.

Hepatitis E is clinically indistinguishable from other types of acute viral hepatitis. It is especially a problem in developing countries, with outbreaks most common during rainy seasons and in areas with poor sanitation.[1] In India, the lifetime infection risk surpasses 60%, which results in hundreds of thousands of illnesses annually.[2]

Hepatitis E typically has a 40-day incubation period, with the highest attack rates in those 15 to 40 years old.[3] Illness severity increases with age, and the overall case-fatality ratio is estimated to be 1 to 3%.[4],[5] Pregnant women are at greatest risk, and 5 to 25% of those infected during pregnancy die. Survivors have high rates of spontaneous abortion and still birth.[6]

Two thousand volunteers participated in the double-blind, placebo-controlled trial, conducted in accordance with international clinical guidelines and monitored by independent, international review boards.

"GSK involvement dates from 1993. The development of this vaccine is the latest product of GSK's and Walter Reed's more than 20-year history of collaboration to develop vaccines for diseases in the developing world. The promising results of this trial are proof that together we can find the technology to protect those at risk," added Dr. Innis.

The vaccine technology was first developed by Genelabs, Technologies, Inc, which sequenced the hepatitis E genome. Genelabs has granted an exclusive license to GlaxoSmithKline Biologicals for hepatitis E vaccines. The National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH) developed the candidate vaccine used in this and two earlier clinical trials. NIH also established its viability in preclinical studies. Through an agreement with GlaxoSmithKline, Walter Reed led the vaccine's clinical development, in collaboration with scientists and physicians at GlaxoSmithKline, pursuant to an investigational new drug application filed with the supervision of the U.S. Food and Drug Administration and approvals granted by the Nepal Health Research Council.

Walter Reed and GSK also have worked together to develop vaccines against hepatitis A, dengue and malaria.

GlaxoSmithKline is one of the leaders in the pharmaceutical industry in R&D for diseases of the developing world. GSK is the only company developing medicines to treat, and vaccines to prevent, the World Health Organization's three priority infectious diseases: AIDS, malaria, and TB. GSK conducts a portion of its developing country disease R&D through public-private partnerships with a range of groups supported by donor governments and charities such as the Bill & Melinda Gates Foundation.

GSK is also a leading vaccine supplier to the developing world through UNICEF and GAVI. The company pioneered tiered pricing for its vaccines, offering lower prices for the public sectors of the world's poorest countries.

About GSK Biologicals

GSK is one of the world's leading vaccine manufacturers. The majority of GSK's activities in the field of vaccine research, development and production are conducted at its Biologicals headquarters in Rixensart, Belgium. GSK Biologicals employs more than 1,500 research scientists devoted to discovering new vaccines and developing more cost-effective and convenient combination products to prevent infections that cause serious medical problems worldwide.

In 2006, GSK distributed more than 1.1 billion doses of vaccines to 169 countries in both the developed and developing world, more than 3 million doses per day.

GlaxoSmithKline is one of the world's leading research-based pharmaceutical and health care companies. GlaxoSmithKline is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information visit http://www.gsk.com.

References

[1] Krawczynski K, Aggarwal R, Kamili S. Epidemiology, clinical and pathologic features, diagnosis, and experimental models. In: Thomas HC, Lemon S, Zuckerman AJ, eds. Viral Hepatitis. Malden, Massachusetts: Blackwell Publishing, LTD; 2005:624-34.

[2]Worm HC, Wirnsberger G. Hepatitis E vaccines: progress and prospects. Drugs 2004;64(14):1517-31.

[3] Emerson SU, Purcell RH. Hepatitis E virus. Rev Med Virol 2003;13(3):145-54.

[4] Purcell RH. Hepatitis viruses: changing patterns of human disease. Proc Natl Acad Sci U S A 1994;91(7):2401-6.

[5] Balayan MS. Epidemiology of hepatitis E virus infection. J Viral Hepat 1997;4(3):155-65.

[6] Krawczynski K, Aggarwal R, Kamili S. Epidemiology, clinical and pathologic features, diagnosis, and experimental models. In: Thomas HC, Lemon S, Zuckerman AJ, eds. Viral Hepatitis. Malden, Massachusetts: Blackwell Publishing, LTD; 2005:624-34.

GlaxoSmithKline
http://www.gsk.com

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