Hepatitis E

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

Don Hackett — Wed, 15 May 2019 16:18:59 +0000

Reviewer:

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.

Sub Title:

Innovax Hecolin HEV-239 is the only Hepatitis E Virus vaccine available

References:

Safety Study of Hepatitis E Vaccine (HEV239) in Healthy US Adult Population

New Hepatitis E Guidelines, But Still No Vaccine For Americans

Chinese HEV vaccine begins clinical trial in US

New Clinical Trial for Hecolin®, Hepatitis E Vaccine of Innovax in the US

Hepatitis E Vaccine: Composition, Safety, Immunogenicity and Efficacy

An Optimized High-Throughput Neutralization Assay for Hepatitis E Virus (HEV) Involving Detection of Secreted Porf2

Chinese HEV vaccine begins clinical trial in US

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Clinical Trials

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Rare Hepatitis E Case Reported in Hong Kong

Don Hackett — Fri, 28 Sep 2018 13:12:15 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The world's first instance of a human being infected with rat hepatitis E virus was reported by the University of Hong Kong (HKU) on September 27, 2018.

The patient was placed on immunosuppressant drugs and showed persistently abnormal liver function tests results. This indicated problems with his liver graft.

Further tests showed the patient was carrying a species of hepatitis virus that until then was known to be present only in animals, such as rats.

The test results were “highly divergent” from the hepatitis E strain that affects humans, the HKU researchers said.

Before this case, there had been no previous evidence that rat hepatitis E, one of the variants of the virus that affects mammals, could be transmitted to humans.

Hepatitis E is a liver disease caused by infection with a virus known as the hepatitis E virus (HEV), says the World Health Organization (WHO).

Traditionally, the HEV is transmitted by the fecal-oral route, principally via contaminated water. And, HEV belongs to the Hepeviridae, a diverse family of viruses infecting mammals, birds, and fish.

Cases of HEV typically present in one of two ways, either as large outbreaks and sporadic cases in areas where HEV is endemic (genotype 1) in Asia and Africa, (genotype 2) in Mexico and West Africa and (genotype 4) in Taiwan and China or as isolated cases in developed countries (genotype 3), reports the WHO.

This hepatitis E case emerged when a patient had undergone a liver transplant on May 14th at HKU’s teaching hospital Queen Mary, reports SCMP news.

“We postulate that contamination of food by infected rat droppings in the food supply is possible,” HKU researchers said. “Although they noted that the route of transmission of the virus, in this case, remained unclear.”

During the summer of 2018, Hong Kong faced a rampant rodent problem, with control officers reporting double-digit growth in demand for their services over the past few months, reported SCMP.

Every year, the hepatitis E virus infects about 20 million people worldwide, leading to an estimated 3.3 million symptomatic cases, says the WHO.

Most people with Hepatitis E recover completely. During HEV outbreaks, the overall case-fatality rate is about 1 percent.

However, for pregnant women, Hepatitis E can be a serious illness with mortality reaching 10–30 percent in their third trimester of pregnancy.

The WHO estimates that hepatitis E caused approximately 44,000 deaths in 2015.

The only hepatitis E vaccine is available from China.

Xiamen Innovax Biotech CO., LTD. launched the world’s first Hepatitis E Vaccine, Hecolin® in China in October 2012. Hecolin is considered a promising vaccine which has shown a high degree of efficacy in China.

But, as of May 2018, there was not a US Centers for Disease Control and Prevention (CDC) approved hepatitis E vaccine.

Details of the University of Hong Kong HEV study, regarding rodent transmission, led by Professor Yuen Kwok-Yung and Dr. Siddharth Sridhar from the department of microbiology, will be published in the medical journal Emerging Infectious Diseases in December 2018.

Sub Title:

Xiamen Innovax Biotech Hecolin hepatitis E vaccine has shown a high degree of efficacy in China

References:

World’s first case of rat hepatitis E infecting a human discovered in Hong Kong man, 56

Rise of the rats: Hong Kong’s hot weather is forcing rodents up high-rises

Hepatitis E

What is Hepatitis E?

Hepatitis E Outbreak in Africa Receives USA Support

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Hepatitis E Outbreak in Africa Receives USA Support

Don Hackett — Tue, 10 Jul 2018 15:36:30 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The ambassador of the United States of America to Namibia, Lisa Johnson, has promised the USA will continue to assist Namibia in its fight against the outbreak of hepatitis E.

More than 1,569 people are suspected of having contracted hepatitis, while 15 people have died from the disease, of whom 6 were pregnant women.

This hepatitis E outbreak in Windhoek was declared an emergency by the World Health Organization (WHO) in December 2017

Although hepatitis A and B are common in Namibia, hepatitis E virus (HEV) is rarely diagnosed in the country. As a result, the country has limited capacity for hepatitis E laboratory diagnostics.

The WHO estimates that hepatitis E caused approximately 20 million infections worldwide in 2015, with 44,000 deaths, which is a 3.3 percent mortality rate.

According to reporting by ReliefWeb Ambassador Johnson made this promise on July 6, 2018, after visiting Havana and Goreangab informal settlements in the Samora Machel Constituency, Windhoek, which is on the southwest section of Africa.

The majority of hepatitis E cases during the current outbreak have been reported in informal settlements where water and sanitation are compromised.

Hepatitis E is a liver infection spread either by direct contact with an infected person’s feces or by indirect fecal contamination of food or water. Infection is more severe among pregnant women as they are at greater risk of acute liver failure, fetal loss, and death.

HEV belongs to the Hepeviridae, a diverse family of viruses infecting mammals, birds, and fish.

Strains of HEV infecting humans belong to the Orthohepevirus genus which is divided into four species (A–D). Human cases of hepatitis E are caused by strains within species A, which comprises eight genotypes.

“We are seeing that there are still new cases in the areas of Windhoek every week and that’s actually not to be unexpected, it does take months to get the hepatitis E outbreak under control,” said Ambassador Johnson.

She said the US embassy is currently in discussions with the health ministry on whether it will be useful for her country to send another team from US Centers for Disease Control and Prevention (CDC) to take a look at the epidemic and provide technical assistance and advice on the response.

The CDC has not issued a Travel Alert for visiting Namibia but does suggest several vaccinations prior to arrival.

But, there is not a CDC approved hepatitis E vaccine available today.

The only hepatitis E vaccine is available in China. Xiamen Innovax Biotech CO., LTD. launched the world’s first Hepatitis E Vaccine--Hecolin® in China in October 2012.

The Hepatitis E vaccine HEV 239 vaccine, Hecolin is considered a promising vaccine which has shown a high degree of efficacy in 16 to 65-year-old healthy subjects in China.

However, data on the incidence of hepatitis E virus infection and disease worldwide, and the contribution of hepatitis E to mortality in the general population where the infection is common is very limited, says the WHO.

“We will continue to assist, and I think in mid-July the National Health Emergency National Committee is going to have some sort of six months response review to see how we are doing altogether and what needs to be done next,” she said.

She said she thought it was very useful to see first-hand what some of the challenges the residents face and how the responses are working.

Ambassador Johnson was accompanied by the Khomas Governor Laura McLeod-Katjirua, Samora Machel Constituency Councillor Fanuel Shivute and health officials of both the City of Windhoek and the Ministry of Health.

Sub Title:

Hecolin (HEV 239) is a hepatitis E vaccine that has shown a high degree of efficacy in 16 – 65-year-old healthy subjects in China

References:

US pledges assistance to contain hepatitis E

Hepatitis E vaccine

New Hepatitis E Guidelines, But Still No Vaccine For Americans

Weekly Bulletin

Namibia International Travel Informaiton

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New Hepatitis E Guidelines, But Still No Vaccine For Americans

Don Hackett — Wed, 11 Apr 2018 19:10:00 +0000

Reviewer:

Kelley Lu, PharmD

Robert Carlson, MD

Danielle Reiter, RN

There is a type of hepatitis getting very little attention in the USA, even though it is a deadly type of liver disease.

The Hepatitis E Virus (HEV) was previously thought to be limited in developing countries and was only ever seen in international travelers returning from endemic areas, such as Asia or Africa.

But, new research says that HEV is now endemic in most high-income countries as well.

However, the only hepatitis E vaccine is available in China.

Xiamen Innovax Biotech CO., LTD. (INNOVAX) is a wholly owned subsidiary of Beijing Wantai Biological Pharmaceutical Co., LTD., under the YangShengTang Group.

Established in 2005, INNOVAX has been dedicated to providing high-quantity and affordable innovative vaccine for people in need to combat infectious disease. They launched the world’s first Hepatitis E Vaccine--Hecolin® in China in October 2012.

The Hepatitis E vaccine HEV 239 vaccine, Hecolin is considered a promising vaccine which has shown a high degree of efficacy in 16 to 65-year-old healthy subjects in China.

Recent reports from the World Health Organization (WHO) have identified HEV ‘hot-spots’ in France, the Netherlands, Scotland, Germany, Czech Republic, Poland, and Italy.

Given this paradigm shift in zoonotic HEV and that locally acquired HEV is now a common cause of acute viral hepatitis in many European countries, new care guidelines were needed.

To address this need, the European Association for the Study of Liver invited a panel of experts to develop Clinical Practice Guidelines (CPGs) with a particular focus on HEV genotype gt 3.

At the molecular level, gt 3 is highly diverse and includes related viruses found in rabbits, with evidence of occasional infection with similar viruses in humans.

The objective of these CPGs is to better define specific suggestions for the management of distinct features of HEV infection, even though the supporting evidence may be weak in many cases.

Regardless of the quality of care evidence, clinicians, patients, and public health authorities must continue to make choices on the basis of the evolving evidence.

The World Health Organization estimates that hepatitis E caused approximately 20 million infections worldwide each year: 44,000 deaths, which is a 3.3 percent mortality rate in 2015.

HEV belongs to the Hepeviridae, a diverse family of viruses infecting mammals, birds, and fish.

Two of these (gt 1 and 2) only infect humans. HEV gt 1 and 2 usually cause a brief, self-limiting hepatitis in young adults that is clinically indistinguishable from other causes of acute viral hepatitis. The clinical attack rate on exposure is approximately 25 percent.

Gt 3 and 4 are endemic in animal species such as pigs and wild boar; these strains cause zoonotic infections in humans, via consumption of contaminated meat or direct contact and other probable routes.

Sub Title:

Hecolin hepatitis E, HEV 239 vaccine is only available in China

References:

Robust manufacturing and comprehensive characterization of recombinant hepatitis E virus-like particles in Hecolin

Hepatitis E vaccine WHO position paper

Hepatitis E

EASL Clinical Practice Guidelines on hepatitis E virus infection

Consensus proposals for classification of the family Hepeviridae

Hepatitis E virus: the current scenario

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Hepatitis E Expands From Pigs to Humans

Don Hackett — Wed, 23 Aug 2017 15:34:59 +0000

Reviewer:

Danielle Reiter, RN

Kelley Lu, PharmD

Robert Carlson, MD

The Hepatitis E Virus (HEV) gets little press compared to its more popular cousins, Hep A, B and C. But, virologists say we should be on alert for how this virus is changing.

While rare in the United States, the World Health Organization (WHO) reports that Hepatitis E virus infections are the most common cause of acute viral hepatitis worldwide.

The infection usually resolves within weeks, but sometimes causes acute liver failure, which may be fatal.

Historically, HEV transmission was primarily zoonotic in industrialized countries, and by fecal–oral transmission in developing countries, due to poor sanitation.

That picture is starting to change.

Scientists have begun noticing a shift from hepatitis E as only a disease of the poor, to one that can also affect affluent people in developed world settings.

Researchers say people are acquiring the HEV infection from pigs and pork products in countries like the United Kingdom and France.

As an example, in England, an un-named supermarket may have infected thousands of people with the Hepatitis E virus by selling imported pork.

According to new research, pork imported from Europe might be transmitting the virus and infecting between 150,000 and 200,000 British people a year with the virus.

Additionally, a team of French researchers identified rabbit HEV in a small number of human patients who were infected with HEV. These researchers could not identify the source of HEV3-ra infection, given that none of the patients infected with this subtype had direct contact with a rabbit.

Interestingly, several of these HEV3-ra infected patients ate rabbit meat, but the meat was reported to be well cooked.

Such findings, the researchers wrote, “emphasize the zoonotic risk for HEV3-ra and expand the spectrum of potential sources of human infection.”

Complicating the picture further is the fact that HEV is not limited to pigs as hosts. Meat from wild boar and other game animals may also be tainted with the virus, as may seafood items.

Dr Tongai Maponga, a post-doctoral fellow in the Division of Medical Virology at Stellenbosch University, says: "HEV has the potential to become a chronic infection, especially in immunosuppressed patients.’

Of the 5 HEV genotypes infecting humans, HEV3 is the most prevalent. It spreads to humans through direct contact with infected pigs as well as through food and environmental contamination.

The HEV3 genotype has 3 subtypes. Two are found in humans and pigs; the third subtype, HEV3-ra, is found in rabbits. To date, only 1 study has reported a human HEV3-ra infection, reflecting the relatively unknown contribution of HEV3-ra to human HEV infection.

Human HEV3 infections are rare, potentially because humans eat far less rabbit than pork.

According to the WHO, every year, there are an estimated 20 million HEV infections worldwide, leading to an estimated 3.3 million symptomatic cases of hepatitis E. WHO estimates that hepatitis E caused approximately 44,000 deaths in 2015.

Which means, Hepatitis E accounts for 3.3% of the mortality due to all hepatitis cases.

There is no specific treatment capable of altering the course of acute hepatitis E. As the disease is usually self-limiting, hospitalization is generally not required.

Immunosuppressed people with chronic hepatitis E benefit from specific treatment using ribavirin, an antiviral drug. In some specific situations, interferon has also been used successfully, according to the WHO.

No FDA-approved vaccine for Hepatitis E is currently available in the United States. However, in 2011, a recombinant subunit vaccine to prevent hepatitis E virus infection was registered in China. It has not yet been approved in other countries.

Sub Title:

Hepatitis E virus sources include zoonotic and poor sanitation

References:

Rabbit Hepatitis E Virus Infections in Humans, France

Hepatitis E

Should we be worried about hepatitis E?

Thousands at risk of pig virus from ‘Supermarket X’ sausages

Hepatitis E FAQs for Health Professionals

Pork products associated with human infection caused by an emerging phylotype of hepatitis E virus in England and Wales

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