Hepatitis

Unraveling Key Determinant of Chronic Hepatitis B Vaccination

Donald Hackett — Mon, 16 Jan 2023 17:44:16 +0000

Reviewer:

The role of viral hepatitis as a public health threat has long been underestimated. For example, over 800,000 people die each year from the consequences of a hepatitis B virus (HBV) infection.

The United Nations' 2030 Agenda for Sustainable Development project recently called for action to reduce this global disease.

While prophylactic vaccines are available to prevent HBV infection, more than 3% of the world's population are chronically infected and do not benefit.

In response, a research team from Germany recently announced they highlighted the success of therapeutic hepatitis B vaccination depends on the efficient priming of HBV-specific CD4 T cells.

These researchers from the Institute of Virology at Helmholtz Munich, the Technical University of Munich, and the German Center for Infection Research found the benefits of heterologous prime-boost vaccination deliver a more robust and longer-lasting immunity.

Most essential is the optimization of TherVacB prime- and boost vaccination strategies requires a thorough understanding of which vaccine component activates the different immune system cells, like T- or B cells.

These factors are essential for breaking immune tolerance in HBV carriers and determining a successful outcome of therapeutic vaccination.

Therapeutic vaccination is a promising, potentially curative treatment for chronic hepatitis B, wrote these researchers on January 9, 2023.

This study provides the first direct evidence that efficient priming of HBV-specific CD4 T cells determines the success of therapeutic hepatitis B vaccination in two preclinical HBV-carrier mouse models.

Applying an optimal formulation of HBV antigens that allows activating CD4 and CD8 T cells during prime immunization provided the foundation for an antiviral effect of therapeutic vaccination.

While depletion of CD4 T cells leads to a complete loss of vaccine-induced antiviral efficacy.

Boosting CD8 T cells was essential to control HBV in these mouse models.

Our findings provide important insights into the rational design of therapeutic vaccines to cure chronic hepatitis B, wrote these researchers.

This study also confirms and expands the textbook knowledge in a concrete case and underlines the importance of the prime vaccination to nudge the immune system in the desired direction.

It thus serves to develop or improve therapeutic vaccines against chronic hepatitis B - and maybe other chronic or malignant diseases - and hopefully help to accelerate the progress towards a cure for chronic hepatitis B, which will be a great benefit for millions of hepatitis B patients worldwide, wrote these researchers.

This research was published in the Journal of Hepatology on January 9, 2023. This project received funding from the German Research Foundation and others. No industry conflicts of interest were disclosed.

In the U.S., the Advisory Committee on Immunization Practices recommends various people receive hepatitis B vaccination. Other hepatitis B vaccine news is posted at PrecisionVaccinations.

Sub Title:

Therapeutic hepatitis B vaccine activates CD4 T cells during prime immunization

References:

Activation of CD4 T cells during prime immunization determines the success of a therapeutic hepatitis B vaccine in HBV-carrier m

Determinant of successful therapeutic vaccination against chronic hepatitis B

World Hepatitis Day

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Journal of Hep, Jan 2023 - Activation of CD4 T cells during prime immunization

Hepatitis A Outbreaks Changed in 2016

Karen McClorey Hackett — Fri, 14 Oct 2022 12:31:56 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

When most people hear about hepatitis A, they think about a virus associated with contaminated food and water. However, since 2016, hepatitis A has been more commonly spread from person to person, reported the U.S. Centers for Disease Control and Prevention (CDC).

The CDC's Division of Viral Hepatitis (DVH) reported that from August 2016 to October 7, 2020, 37 states reported hepatitis A outbreaks involving approximately 44,660 cases.

Because hepatitis A causes liver inflammation, people with other forms of viral hepatitis and anyone with underlying liver disease are at risk of more severe illness if infected.

Among cases with available information, 56% of persons reported drug use, 14% reported homelessness, and 61% were hospitalized, medium age of 38, and fewer than 1% of cases occurred among minors.

And among patients with available race data, about 81% occurred among White persons.

In total, 417 outbreak-associated fatalities have been reported.

In collaboration with state and local health departments, the CDC launched a large-scale, multidisciplinary response in 2017 to control the ongoing outbreaks.

The epidemiologic shifts identified during these outbreaks led to a 2019 recommendation by the CDC's Advisory Committee on Immunization Practices for vaccinating persons experiencing homelessness and reinforcement of existing vaccination recommendations for persons who use drugs.

As a result, substantial progress in preventing and controlling hepatitis A (HAV) has been made.

The number of outbreak-affected states has been reduced to 13.

According to the CDC, the current active leaders are Tennessee (3,157) and Indiana (2,683).

Health departments implemented nontraditional vaccination strategies to provide hepatitis A vaccination where needed.

These included holding satellite vaccination clinics and broadening the scope of healthcare professionals approved to administer vaccines.

To overcome barriers to vaccination, including mistrust, stigma, and vaccine hesitancy, health departments partnered with organizations that have long-standing trusted relationships with persons at risk for HAV infection, wrote the CDC.

Serologic testing is not required to administer a hepatitis A vaccine.

Despite long-standing vaccination recommendations, many adults at increased risk for HAV infection remain vulnerable to infection.

Given the hospitalization rate during these outbreaks and the high level of susceptibility to HAV infection, efforts are needed to improve awareness of and adherence to vaccination recommendations, concluded this CDC report.

Related Hepatitis A News

Countries Can Tackle Viral Hepatitis.

Hepatitis A, the Other Vaccine-Preventable Outbreak.

Most Hepatitis A Outbreaks Are Unannounced in the USA.

Will Hepatitis Be On the Menu in 2020?

The updated list of U.S. FDA-Approved hepatitis vaccines and vaccine candidates are published on this webpage.

Hepatitis A vaccines are generally available at clinics and pharmacies in the U.S.

Other hepatitis vaccine news is posted at PrecisionVaccinations.com/Hepatitis.

PrecisionVaccinations publishes fact-checked, research-based vaccine news manually curated for mobile readers.

Sub Title:

Hepatitis A is a vaccine preventable disease

References:

Hepatitis A across the U.S.

Person-to-Person Transmission — United States, 2016–2020

Hepatitis vaccines 2022

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Hepatitis A Cases in the USA

Countries Can Tackle Viral Hepatitis

Karen McClorey Hackett — Thu, 08 Sep 2022 18:20:13 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The World Economic Forum (WEF) recently published a white paper detailing one country's remarkable success against viral hepatitis.

Through expert analysis of specific policies, the WEF paper - The Art and Science of Eliminating Hepatitis: Egypt's Experience - highlighted how the concerted efforts implemented in Egypt could provide an actionable and practical roadmap for other nations.

Egypt's unprecedented campaign in which 60 million people were screened and 4 million successfully treated offers vital lessons informing global eradication efforts.

The scale of the problem is significant. Viral hepatitis currently affects over 300 million people globally.

And the five hepatitis viruses – hepatitis A, hepatitis B, hepatitis C, hepatitis D, and hepatitis E – are distinct and can spread differently.

The World Health Organization (WHO) estimates that 4.5 million deaths could be averted in the next nine years if countries scale up hepatitis elimination campaigns.

"Hepatitis C is a disease that can be beaten," commented Shyam Bishen, Head of Health and Healthcare, WEF, and one of the report's co-authors, on September 6, 2022.

"We can screen and diagnose for it, we can cure it."

"There is a strong business case for nearly every country in the world. However, Egypt has shown that even the highest-burden countries can make incredible progress in a very short timeframe with enough political commitment."

"Ultimately, there are many major health challenges that cannot yet be overcome," said Bishen.

"But viral hepatitis is not one of them."

By bringing together public, private, and non-profit stakeholders, the WEF aims to unlock new financing and design public-private partnerships to help eliminate the disease as a public health threat.

Additionally, the WHO published the updated criteria for validation of elimination of viral hepatitis B and C on September 1, 2022, which was initiated in 2007.

A series of country pilots were undertaken in Brazil, Egypt, Georgia, Mongolia, Rwanda, Thailand, and the United Kingdom of Great Britain and Northern Ireland during 2021–2022.

The main objective was to conduct a practical assessment and evaluate the feasibility of accurately measuring the impact and programmatic targets for hepatitis elimination as established by the WHO Interim guidance for country validation of viral hepatitis elimination.

Validation of elimination of mother-to-child transmission, or vertical transmission, of HIV, syphilis, and hepatitis B virus, is an attestation that a country has successfully met standard criteria for elimination or for being at 1 of the three levels of achievement on the 'Path to Elimination.'

An updated listing of U.S. FDA-approved hepatitis vaccines, and candidates, is posted on this PrecisionVaccinations webpage.

PrecisionVaccinations publishes fact-checked research-based vaccine news.

Note: This information was manually translated and curated for mobile readership.

Sub Title:

Hepatitis can be prevented with vaccines

References:

World Economic Forum

WHO: Criteria for validation of elimination of viral hepatitis B and C

Hepatitis Vaccines

The Art and Science of Eliminating Hepatitis: Egypt’s Experience

Global guidance on criteria and processes for validation

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by Keith Johnston

Scientists Discover How a Protein and Enzymes Enabling Hepatitis A Virus Replication

Karen McClorey Hackett — Fri, 08 Jul 2022 17:53:55 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

While focusing on the viral replication cycle in the hepatitis A virus (HAV), UNC School of Medicine scientists recently discovered that replication requires specific interactions between the human protein ZCCHC14 and a group of enzymes called TENT4 poly(A) polymerases.

They also found that the oral compound RG7834 stopped replication at a critical step, making it impossible for the virus to infect liver cells.

These findings were published in the Proceedings of the National Academy of Sciences on July 7, 2022, and are the first to demonstrate an effective drug treatment against HAV in an animal model of the disease.

“Our research demonstrates that targeting this protein complex with an orally delivered, small-molecule therapeutic halts viral replication and reverses liver inflammation in a mouse model of hepatitis A, providing proof of principle for antiviral therapy and the means to stop the spread of hepatitis A in outbreak settings,” commented senior author Stanley M. Lemon, M.D., professor in the UNC Department of Medicine and UNC Department of Microbiology & Immunology, and member of the UNC Institute for Global Health and Infectious Diseases.

Dr. Lemon, who in the 1970s and 80s was part of a Walter Reed Army Medical Center research team that developed the first inactivated HAV vaccine administered to humans, said research on HAV tapered off after the vaccine became widely available in the mid-1990s.

The good news is HAV cases plummeted in the 2000s as vaccination rates skyrocketed.

Not everyone gets vaccinated, Lemon pointed out, and HAV can exist for long periods in the environment – such as on our hands and in food and water.

Several outbreaks have occurred over the past several years, including in San Diego in 2017, primarily driven by homelessness and illicit drug use, causing severe illness in about 600 people and killing 20.

In 2022, a small outbreak was linked to organic strawberries in multiple states, leading to about a dozen hospitalizations.

As of July 1, 2022, since the HAV outbreaks were first identified in 2016, 37 states reported 44,696 cases, hospitalizations (61%), and 423 related fatalities.

Symptoms include fever, abdominal pain, jaundice, nausea, loss of appetite, and a sense of taste.

Once sick, there is no treatment.

In 2013, Lemon and colleagues discovered that the hepatitis A virus changes dramatically inside the human liver.

The virus hijacks bits of the cell membrane as it leaves liver cells, cloaking itself from antibodies that would have otherwise quarantined the virus before it spread widely through the bloodstream.

This work was published in Nature and provided insight into how much researchers had yet to learn about this virus discovered 50 years ago and likely caused diseases dating back to ancient times.

Lemon’s lab led experiments to search for human proteins that HAV needs to replicate, and they found ZCCHC14 – a particular protein that interacts with zinc and binds to RNA.

“This was the tipping point for this current study,” Lemon said.

“We found ZCCHC14 binds very specifically to a certain part of HAV’s RNA, the molecule that contains the virus’s genetic information. And as a result of that binding, the virus can recruit TENT4 from the human cell.”

In normal human biology, TENT4 is part of an RNA-modification process during cell growth. Essentially, HAV hijacks TENT4 and uses it to replicate its own genome.

This work suggested that stopping TENT4 recruitment could stop viral replication and limit disease.

Lemon’s lab then tested the compound RG7834, which had previously been shown to actively block the Hepatitis B virus by targeting TENT4.

In the new PNAS paper, the researchers detailed the precise effects of oral RG7834 on HAV in liver and feces and how the virus’s ability to cause liver injury is dramatically diminished in mice that had been genetically modified to develop HAV infection and disease.

The research suggests the compound was safe at the dose used in this research and the acute timeframe of the study.

“This compound is a long way from human use,” Lemon said, “But it points the path to an effective way to treat a disease for which we have no treatment at all.”

The pharmaceutical company Hoffmann-La Roche developed RG7834 for use against chronic hepatitis B infections and tested it in humans in a phase 1 trial, but animal studies suggested it may be too toxic for use over long periods.

“The treatment for Hepatitis A would be short-term,” Lemon said, “and, more importantly, our group and others are working on compounds that would hit the same target without toxic effects.”

The hepatitis A vaccination is the best way to prevent HAV infection, says the CDC.

One dose of single-antigen hepatitis A vaccine has been shown to control outbreaks of hepatitis A.

Hepatitis A Vaccine News

Hepatitis A, the Other Vaccine-Preventable Outbreak

Hepatitis A Unintentionally Served at Starbucks

North Carolina Confirms 495 Hepatitis A Cases

This research was a collaboration between the Lemon lab and the lab of Jason Whitmire, professor of genetics at the UNC School of Medicine. Lemon and Whitmire are members of the UNC Lineberger Comprehensive Cancer Center.

This work was supported by grants from the National Institute of Allergy and Infectious Diseases. In addition, the UNC Pathology Services Core and UNC High-Throughput Sequencing Facility were partially supported by a National Cancer Institute Center Core Support Grant to the UNC Lineberger Comprehensive Cancer Center. No industry conflicts of interest were disclosed.

PrecisionVaccinations publishes fact-checked, research-based vaccine news curated for mobile readership.

Sub Title:

Hepatitis A outbreaks produced over 420 fatalities since 2016

References:

Scientists Discover Key to Hepatitis A Virus Replication, Show Drug Effectiveness

The ZCCHC14/TENT4 complex is required for hepatitis A virus RNA synthesis

Hepatitis Vaccines 2022

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by Gerd Altmann

Severe Acute Hepatitis Cases in Children Increase 41%

Don Hackett — Sat, 25 Jun 2022 16:31:07 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The World Health Organization (WHO) announced yesterday that since the previous Disease Outbreak News published on May 27, 2022, there have been 270 new probable severe acute hepatitis of unknown etiology in children cases, including from four new countries.

As of June 22, 2022, thirty-three countries in five WHO Regions have reported 920 probable cases since this global outbreak began in October 2021.

This data indicates a 41% increase during the last month.

The WHO says The actual number of cases may be underestimated, partly due to the limited enhanced surveillance schemes in place. The case count is expected to change as more information and verified data become available.’

Of these probable cases, 45 (5%) children have required transplants, and 18 related fatalities have been reported to WHO.

Epidemiological, clinical, laboratory, histopathological, and toxicological investigations of the cases' possible etiology (or aetiologies) are underway by several national authorities and research networks, across different working groups in WHO and with partners.

However, ‘the risk at the global level is currently assessed as moderate,’ stated the WHO on June 24, 2022.

Separately, the U.S. CDC published a Morbidity and Mortality Weekly Report - Interim Analysis of Acute Hepatitis of Unknown Etiology in Children Aged <10 Years, on June 24, 2022.

This CDC report stated that from October 1, 2021–June 15, 2022, 296 pediatric patients received a diagnosis of hepatitis of unknown etiology, with adenovirus detected among about 45%.

The preliminary analyses of these children (ave. 26 months) have not identified common exposures. About 56% had never attended a childcare facility or school.

However, current (10.2%) or past (26%) infection with the SARS-CoV-2 coronavirus was reported. And most of these children were not eligible for COVID-19 vaccination.

‘Current U.S. data do not suggest an increase in pediatric hepatitis of unknown etiology or percent positivity for adenovirus types 40/41 over baseline levels. However, the investigation is ongoing; further clinical data are needed to understand the cause of these cases and to assess the potential association with adenovirus,’ says the CDC.

Additionally, the United Kingdom Health Security Agency (UKHSA) continues to investigate and confirm cases of sudden onset hepatitis in children that have been identified since January 2022.

Since the UKHSA’s last update on June 17, 2022, active investigations have identified seven additional pediatric cases, bringing the total number in the UK to 258.

Of the confirmed cases, 183 are residents in England.

The UKHSA has published an epidemiological update #3 on the UK-wide investigations, which says, ‘While new cases continue to be identified across the UK, there is an overall decline in the number of new cases reported per week, even allowing for reporting lags.’

‘Cases pending classification are usually those in which laboratory testing to rule out known causes of hepatitis has not been completed.’

‘The leading hypotheses remain those which involve adenovirus; however, we continue to investigate the potential role of SARS-CoV-2 and work on ruling out any toxicological component.’

Additional acute hepatitis in children news is posted at PrecisionVaccinations.com/Acute.

PrecisionVaccinations publishes fact-checked, research-based news curated for mobile readership.

Sub Title:

WHO reports 920 probable hepatitis of unknown etiology in children

References:

WHO:Severe acute hepatitis of unknown aetiology in children - Multi-country

CDC: Interim Analysis of Acute Hepatitis of Unknown Etiology in Children Aged < 10 years

GOV.UK: Hepatitis (liver inflammation) cases in children – latest updates

GOV.UK: Acute hepatitis: technical briefing

ACUTE HEPATITIS CHILDREN

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health, vaccines, vaccinations, hepatitis, acute hepatitis, children , liver disease, hepatitis and children, covid and kids

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WHO

Over 650 Children Impacted by Mysterious Acute Hepatitis

Karen McClorey Hackett — Sat, 28 May 2022 14:43:49 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The World Health Organization (WHO) latest report revealed the number of children impacted by the 'acute hepatitis of unknown etiology' increased by over 100% in May 2022.

Published on May 27, 2022, the WHO's Outbreak at a Glance confirmed 650 probable cases of acute hepatitis of unknown etiology in children had been reported to the WHO from 33 countries in five WHO Regions between April 5th and May 26th.

Furthermore, 99 additional cases are pending classification.

The WHO stated, 'The actual number of cases may be underestimated.'

This data contrasts with the WHO/ECDC May 20th report, when 276 pediatric cases were reported from the European region.

As of yesterday, the WHO stated, 'Based on the working case definition for probable cases, laboratory testing has excluded hepatitis A-E viruses in these children.'

And the 'United Kingdom (UK) has recently observed an increase in adenovirus activity, which is co-circulating with the SARS-CoV-2 coronavirus, though the role of these viruses in the pathogenesis is not yet clear.'

The UK has reported the highest number of cases, with 222.

The WHO also confirmed the following data:

About 75% of cases are younger than five years of age.
Of 156 patients with information on hospital admission, 14% were admitted to an intensive care unit.
Of the 117 cases for which this information was available, 12% have received a liver transplant.
Serology results for SARS-CoV-2 were only available for a few instances, of which 73% had a positive finding.
Of the 63 cases with data on COVID-19 vaccination, 84% were unvaccinated. And the overall vaccination status (i.e., hepatitis, MMR, polio) was not disclosed.
Human-to-human transmission cannot be ruled out as epidemiologically linked cases are confirmed in Scotland and the Netherlands.
And the WHO did not disclose the COVID-19 vaccination status of these children's families.

'In children with acute hepatitis, the main concern is identifying cases early to ensure optimal case management. While most countries have the capacity for medical treatment of acute hepatitis, this is not true for liver transplantation capacity or intensive support and care for liver failure.'

'Further detailed epidemiological, clinical, laboratory, histopathological and toxicological investigations of the possible cause(s) of these cases are underway by several national authorities, research networks and across different working groups in WHO and with partners,' stated the WHO.

Dr. Renu Bindra, Senior Medical Advisor and Incident Director at the UK's Health Security Agency, said in a media briefing issued on May 27, 2022, "Our investigations continue to suggest an association with adenovirus, and we are exploring this link, along with other possible contributing factors including prior infections such as COVID-19."

"The likelihood of children developing hepatitis remains extremely low."

In the USA, the Centers for Disease Control and Prevention (CDC) recently stated, 'While rare, children can have serious hepatitis, and we don't always know the cause.'

As of May 25, 2022, the CDC announced that 33 states and territories had reported 216 Persons Under Investigation (PUI). A PUI does not mean this person is a confirmed case.

The CDC is reviewing children's cases as of October 2021, so this number may go up or down as more medical charts are reviewed.

In early May, Dr. Jay Butler, the CDC's deputy director for infectious diseases, said during a digital briefing, "We are unaware of cases occurring in kids that have documented COVID-19. But it's a question that I think is still unanswered."

Additional pediatric hepatitis outbreak news is posted at PrecisionVaccinations.com/Acute.

PrecisionVaccinations publishes fact-checked, research-based news curated for mobile readership. Dr. Carlson updated this article for clinical clarity and data sources.

Sub Title:

Acute hepatitis risk in children remains low

References:

WHO: Acute hepatitis of unknown aetiology in children - Multi-country

Multi-Country – Acute, severe hepatitis of unknown origin in children

CDC:Children with Acute Hepatitis of Unknown Etiology

CDC Media Telebriefing: Update on Acute Hepatitis of Unknown Cause

Joint ECDC-WHO Regional Office for Europe Hepatitis of Unknown Origin in Children Surveillance Bulletin

ACUTE HEPATITIS CASES IN CHILDREN 2022

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11 Liver Transplants in UK Children After Mysterious Inflammation

Don Hackett — Sat, 21 May 2022 17:58:03 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The UK Heath Security Agency (UKHSA) published Technical Briefing #3 yesterday, summarizing the ongoing investigations into the unusual rates of acute liver inflammation (hepatitis) with unknown etiology in children.

The UKHSA’s document issued on May 20, 2022, reviews the clinical outcomes for 197 pediatric cases, most living in England. One hundred and eighty of these children were hospitalized, of whom 11 required liver transplantation.

And the usual viruses that cause infectious hepatitis (hepatitis A to E) have not been detected.

The good news is no children in the UK have died from these mysterious infections.

‘It should be noted that the liver inflammation case definitions for children require high -transaminases to be included, and there may be milder cases that have not been reported,’ acknowledged the UKHSA.

Furthermore, the UKHSA investigation continues to suggest an association with adenovirus. Adenovirus (41F) is the most frequently detected virus in samples tested.

So far, the SARS-CoV-2 coronavirus has been detected in about 15% of the UK children with available results, reflecting testing on or around hospital admission.

And there is no evidence of any link to COVID-19 vaccinations since most of these children are three years old and not vaccine-eligible in the UK.

Dr. Renu Bindra, a Senior Medical Advisor at UKHSA, said in a media statement issued on May 19, 2022, ”Our investigations continue to suggest an association with adenovirus infection. Still, we continue to unpick the exact reason for the rise in cases.”

“It’s important that parents know the likelihood of their child developing hepatitis is extremely low.”

“We continue to remind everyone to be alert to the signs of hepatitis – particularly jaundice, look for a yellow tinge in the whites of the eyes – and contact your doctor if you are concerned.”

Research studies of the immune system are also being undertaken in the UK to determine if changes in susceptibility or the effect of prior or concurrent infections could be contributing factors.

According to the European CDC reporting on May 19, 2022, the total number of cases reported worldwide is 614, including 14 deaths, which were reported from Ireland (1), Indonesia (6), Mexico (1), Palestine (1), and the United States (5).

On May 11, 2022, the U.S. CDC issued a Health Alert Network Health Update to provide clinicians and public health authorities with updated information about an epidemiologic investigation of pediatric cases of hepatitis of unknown etiology in the U.S.

And on May 19, 2022, the CDC hosted a web call - Clinical Recommendations for Adenovirus Testing and Reporting of Children with Acute Hepatitis of Unknown Etiology. The CDC had received preliminary reports of 180 patients under investigation through May 18, 2022.

The CDC confirmed about 90% of these children were hospitalized, 8% required a liver transplant, and there have been five related deaths under investigation.

The CDC confirmed it is ‘keeping an open mind and focusing on hypothesis generation, exploring other potential exposures (medications, other infections, toxins, food, water, etc.) as Adenovirus may not be the cause of these pediatric cases.’

Breaking news regarding this outbreak is posted at PrecisionVaccinations.com/Acute.

PrecisionVaccinations publishes fact-checked research-based news.

Sub Title:

Mysterious acute hepatitis cases reach 614, including 14 pediatric fatalities

References:

Investigation into acute hepatitis of unknown aetiology in children in England

CDTR Week 20, 15-21 May 2022

CDC: Acute Hepatitis and Adenovirus Infection Among Children - Alabama, October 2021-February 2022

CDC: Clinical Recommendations for Adenovirus Testing and Reporting of Children with Acute Hepatitis of Unknown Etiology

ACUTE HEPATITIS CASES IN CHILDREN 2022

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427 Acute Liver Cases in Children Continue Baffling Health Experts

Don Hackett — Sat, 07 May 2022 18:01:06 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Health experts across the globe recently issued updates on the ongoing investigation into liver inflammation in children.

On May 6, 2022, the U.S. Centers for Disease Control and Prevention (CDC) confirmed that the unexplained acute liver cases in children had reached 24 states and Puerto Rico.

The CDC confirmed there are now 109 known pediatric liver cases of unknown cause. Unfortunately, there have been seven liver transplants and five related fatalities since October 2021.

Furthermore, there is no known association with hepatitis viruses (A to E) in these children, who were found with serum transaminases greater than 500 IU/l.

The CDC’s deputy director of infectious diseases, Dr. Jay Butler, commented during a telebriefing that 'of the diagnosed children, 90% were hospitalized, with some children still hospitalized.’

And about 50 % of the children had confirmed adenovirus 41F infections. However, he emphasized that the virus might not cause these liver inflammations and that clinical investigators have cast a global net searching for the actual reason.

The association with adenovirus is undergoing a formal epidemiological study.

Similarly, the U.K. Health Security Agency (UKHSA) and the European Centre for Disease Prevention and Control (ECDC) published updated reports, which increased the worldwide number of cases to 427 from about 30 different countries.

Dr. Meera Chand, Director of Clinical and Emerging Infections at UKHSA, commented ‘Currently, there is no evidence of any link to COVID-19 vaccination since most cases are under five years old and are too young to have received the vaccine.’

‘However, about 15% of these children tested positive for a SARS-CoV-2 coronavirus infection.’

The UK’s Technical Report #2 stated, ‘There is no known association with travel, and hepatitis viruses (A to E) have not been detected in these children.’

Most researchers involved in these liver failure investigations have not formulated a hypothesis and continue to question causality vs. coincidence.

The following hypotheses are all being actively tested by the UKHSA investigations in the process:

A typical adenovirus infection
A novel variant adenovirus, with or without a contribution from a cofactor as listed above
A post-infectious SARS-CoV-2 syndrome
A drug, toxin, or environmental exposure
A novel pathogen either acting alone or as a coinfection
A new variant of SARS-CoV-2

On April 29, 2022, the CDC issued an early-release Morbidity and Mortality Weekly Report that stated ‘ the CDC is monitoring the situation closely to understand the possible cause of illness and identify potential efforts to prevent or mitigate disease.’

Moreover, ‘clinicians are encouraged to report possible cases of pediatric hepatitis with unknown etiology occurring on or after October 1, 2021, to public health authorities for further investigation.’

PrecisionVaccinations publishes fact-checked research-based news.

Sub Title:

CDC confirms no known association with hepatitis viruses in these children

References:

Investigation into acute hepatitis of unknown aetiology in children in England

ECDC: COMMUNICABLE DISEASE THREATS REPOR

CDC: Update on Acute Hepatitis of Unknown Cause

CDC: Acute Hepatitis and Adenovirus Infection Among Children - Alabama, October 2021 - February 2022

ADENOVIRUS HEPATITIS CASES IN CHILDREN 2022

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Hepatitis - Adenovirus Outbreak in 169 Children Becomes Severe

Don Hackett — Sun, 24 Apr 2022 13:07:39 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The World Health Organization (WHO) recently confirmed additional reports of cases of acute hepatitis of unknown origin among young children in eleven countries.

As of April 21, 2022, at least 169 cases of acute hepatitis in children have been reported in the WHO European Region and the Americas.

Furthermore, the WHO confirmed seventeen children (one month to 16 years old) had required liver transplantation.

And at least one fatality has been reported.

Cases have been reported in the United Kingdom of Great Britain and Northern Ireland (114), Spain (13), Israel (12), the United States of America (9), Denmark (6), Ireland (<5), The Netherlands (4), Italy (4), Norway (2), France (2), Romania (1), and Belgium (1).

‘It is not yet clear if there has been an increase in hepatitis cases or an increase in awareness of hepatitis cases that occur at the expected rate but go undetected,’ wrote the WHO on April 23, 2022.

The clinical syndrome among identified cases is acute hepatitis (liver inflammation) with markedly elevated liver enzymes.

The common viruses that cause acute viral hepatitis (hepatitis viruses A, B, C, D, and E) have not been detected in any of these cases.

While adenovirus is a possible hypothesis, investigations are ongoing for the causative agent.

Many cases reported gastrointestinal symptoms and increased levels of liver enzymes (aspartate transaminase or alanine amino transaminase greater than 500 IU/L) and jaundice.

Adenovirus was detected in at least 74 cases, and 18 have been identified as F type 41. And the SARS-CoV-2 coronavirus was identified in 20 cases.

Furthermore, there have been 19 children detected with a SARS-CoV-2 and adenovirus co-infection.

The United Kingdom, where most cases have been reported, has recently observed a significant increase in adenovirus infections in the community following low circulation levels earlier in the COVID-19 pandemic.

The Netherlands also reported concurrent increasing community adenovirus circulation.

While adenovirus is currently one hypothesis as the underlying cause, it does not fully explain the severity of the clinical picture.

Adenoviruses are common pathogens that usually cause self-limited infections. They spread from person to person and most commonly cause respiratory illness.

There are more than 50 types of immunologically distinct adenoviruses that can cause infections in humans.

Infection with adenovirus type 41, the implicated adenovirus type, has not previously been linked to such a clinical presentation.

Adenovirus type 41 typically presents as diarrhea, vomiting, and fever, often accompanied by respiratory symptoms.

While there have been case reports of hepatitis in immunocompromised children with adenovirus infection, adenovirus type 41 is not known to cause hepatitis in otherwise healthy children.

Hypotheses related to side effects from the COVID-19 vaccines are currently not supported as the vast majority of affected children did not receive COVID-19 vaccination.

‘With continued new notifications of recent onset cases, at least in the United Kingdom, together with more extensive case searching, it is very likely that more cases will be detected before the cause can be confirmed and more specific control and prevention measures can be implemented,’ wrote the WHO.

The WHO’s priority is to determine the cause of these cases to refine control and prevention actions.

Note: This is one U.S. FDA-approved vaccine - Adenovirus Type 4 and Type 7 Vaccine - but it is reserved for military personnel.

Additional adenovirus - hepatitis outbreak information is posted at PrecisionVaccinations.com/adenovirus.

PrecisionVaccinations publishes fact-checked research-based news.

Sub Title:

Liver transplantation recently completed in seventeen children

References:

WHO: Multi-Country – Acute, severe hepatitis of unknown origin in children

ADENOVIRUS HEPATITIS 2022

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Sunday, April 24, 2022 - 20:15

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WHO

The U.K. Confirms Undefined Hepatitis Outbreak in Children

Karen McClorey Hackett — Tue, 12 Apr 2022 21:47:23 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The UK Health Security Agency (UKHSA) today announced doctors and scientists at the UK’s public health agencies are continuing to investigate 74 cases of hepatitis (liver inflammation) in children since January 2022.

Of these recent hepatitis cases, 49 are in England, 13 are in Scotland, and 12 are in Wales and Northern Ireland.

The number of confirmed cases in such a short time, combined with the geographical spread, is unusual.

For example, Scotland generally reports about 7 or 8 non-A to E hepatitis cases in children annually.

The UKHSA confirmed as of April 12, 2022, the usual viruses that cause infectious hepatitis (hepatitis A to E) have not been detected.

The clinical syndrome of currently identified cases is severe acute hepatitis with markedly elevated transaminases, sometimes preceded by gastrointestinal symptoms, in children up to 13 years.

Some cases have required transfer to specialist children’s liver units, and a small number of children have undergone liver transplantation.

Furthermore, none of the currently confirmed hepatitis cases in the UK has been COVID vaccinated.

This means there is no link to COVID-19 vaccination.

Dr. Meera Chand, Director of Clinical and Emerging Infections at UKHSA, commented in a related press statement, “We are working swiftly with the NHS and public health colleagues in Scotland, Wales, and Northern Ireland to investigate a wide range of possible factors which may be causing children to be admitted to hospital with liver inflammation known as hepatitis.”

“One of the possible causes that we are investigating is that this is linked to adenovirus infection.”

“However, we are thoroughly investigating other potential causes.”

“We are also calling on parents and guardians to be alert to the signs of hepatitis – including jaundice – and to contact a healthcare professional if they are concerned.”

Adenoviruses are a family of common viruses that usually cause mild illnesses, and most people recover without complications. While they don’t typically cause hepatitis, it is a known rare complication of the virus.

Adenoviruses are commonly passed from person to person through the respiratory route and by touching contaminated surfaces.

The most effective way to minimize the spread of adenoviruses is to practice good hand and respiratory hygiene and supervise thorough handwashing in younger children.

The UKHSA stated it is ‘working with partners, will continue to make the public aware of findings throughout the investigation.’

The U.S. CDC says hepatitis means inflammation of the liver and is often caused by a virus. The most common types of viral hepatitis are hepatitis A, B, and C.

And autoimmune hepatitis is a rare cause of long-term hepatitis in which the immune system attacks and damages the liver.

Since 2005, the epidemiology of viral hepatitis in the U.S. has changed substantially.

Decreases in hepatitis A incidence that occurred following the release of the hepatitis A vaccine in the late 1990s ended in 2016, when large person-to-person outbreaks of hepatitis A began in the ‘heartland’ states, such as Kentucky, Indiana, and West Virginia.

Hepatitis A accounts for over 100 million infections per year and tens of thousands of deaths, mainly due to fulminant liver failure, says the WHO.

And decreases in acute hepatitis B incidence that occurred after the release of the hepatitis B vaccine in the 1980s ceased in 2010.

Also, in 2010, decreases in acute hepatitis C incidence that were first observed in the 1990s began to reverse.

Rates of acute hepatitis C have most notably increased among people 20–49 years of age, American Indian/Alaska Native people, and non-Hispanic White people.

The shift in acute hepatitis B and hepatitis C incidence is most evident in jurisdictions disproportionately affected by the opioid crisis.

The CDC recently released updated hepatitis vaccination schedules for children and adults.

The latest hepatitis vaccine news is posted at PrecisionVaccinations.com/Hepatitis.

PrecsionVaccinations publishes fact-checked research-based news.

Updates: EU/EEA Member States can share information about suspected cases on the ECDC EpiPulse platform to facilitate the investigation.

Sub Title:

Scotland and UK report unusual rates of liver inflammation (hepatitis) in children

References:

Increase in hepatitis (liver inflammation) cases in children under investigation

CDC: Viral Hepatitis

Highlights from the Meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization

Hepatitis Vaccines 2022

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Thursday, April 21, 2022 - 19:00

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Fasbytes from Pixabay

Hepatitis A, the Other Vaccine-Preventable Outbreak

Karen McClorey Hackett — Mon, 21 Feb 2022 18:23:19 +0000

Reviewer:

Robert Carlson, MD

When discussing vaccine-preventable hepatitis A infections, many people think about contaminated food and water. However, in 2022, hepatitis A remains a common person-to-person spread virus.

And the risk for hepatitis A virus (HAV) transmission has continued during the COVID-19 pandemic.

Since hepatitis A outbreaks were first identified in 2016, thirty-seven U.S. states have publicly reported 43,705 cases and 420 related fatalities to the U.S. CDC as of February 11, 2022.

Furthermore, 22 states are reporting additional hepatitis A cases in 2022.

The HeartLand-states of Ohio (3,763), Tennessee (3,167), and Indiana (2,660) are the unfortunate leaders.

During the widespread outbreak, Florida (5,103) and Kentucky (5,081) reported the most hepatitis A cases in the USA.

Because hepatitis A causes inflammation of the liver, people with other forms of viral hepatitis and anyone with underlying liver disease are at risk of more severe illness if infected.

People at risk for acquiring HAV infection or developing severe complications from HAV infection during the current hepatitis A outbreaks should be prioritized to receive the hepatitis A vaccine as soon as possible, says the CDC.

Hepatitis A is usually transmitted through food or water that has been contaminated with small, undetectable amounts of feces from a contagious person. Individuals who use drugs, who are experiencing homelessness, or men who have sex with men are at the highest risk for infection during the current outbreak.

Symptoms of hepatitis A include fever, fatigue, nausea, loss of appetite, and stomach pain. Jaundice, dark-colored urine, and clay-colored bowel movements may also occur.

These symptoms appear on average 28 days following infection.

In addition, anyone exhibiting these symptoms should refrain from preparing food for others. Infected individuals can transmit the virus to others two weeks before and one week after jaundice appears.

For example, NBC10 Philadelphia reported in late January 2022, health officials confirmed a third death in a hepatitis A outbreak in Montgomery County, PA, linked to Gino’s Ristorante & Pizzeria in West Norriton.

The Montgomery County Office of Public Health (MCOPH) recently revealed ten confirmed virus cases. The seven survivors were hospitalized but later released.

“The restaurant owner provided a list of restaurant employees working during the exposure period who are expected to return to the restaurant following re-opening,” an MCOPH spokesperson wrote.

“All employees on the list completed voluntary testing for Hepatitis A and were offered Hepatitis A vaccination.”

‘The best way to protect yourself against hepatitis A is through vaccination,’ says the CDC. One dose of single-antigen hepatitis A vaccine has been shown to control hepatitis A outbreaks.

Moreover, prevaccination serologic testing is not required to administer a hepatitis A vaccine.

And vaccinations should not be postponed if vaccination history cannot be obtained or records are unavailable.

An updated list of U.S. FDA Approved hepatitis vaccines and vaccine candidates are published on this webpage.

PrecisionVaccinations publishes fact-checked research-based antibody, antiviral, and vaccine news.

Sub Title:

Serologic testing is not required to administer a hepatitis A vaccine

References:

CDC: State-Reported Hepatitis A Outbreak Cases as of February 11, 2022

CDC: Widespread outbreaks of Hepatitis A across the United States

Hepatitis Vaccines 2022

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Tuesday, February 22, 2022 - 06:00

Hepatitis A Unintentionally Served at Starbucks

Don Hackett — Tue, 23 Nov 2021 19:40:02 +0000

Reviewer:

Robert Carlson, MD

In light of the case of hepatitis A in an employee at a Starbucks located in Gloucester Township, the Camden County Health Department in New Jersey confirmed on November 22, 2021, it is offering vaccines to anyone who feels they may have been exposed.

Based on the investigation and out of an abundance of caution, the Department of Health recommends any unvaccinated member of the public that patronized Starbucks at 1490 Blackwood Clementon Road on Nov. 4, 5, 6, 11, 12, or 13 to get the hepatitis A vaccine.

The Camden County Health Hub is located at 200 College Drive in Blackwood and will operate today from 10 a.m. to 2 p.m. Vaccine appointments will be made on a first-come, first-serve basis.

One dose of single-antigen hepatitis A vaccine has been shown to control outbreaks of hepatitis A, says the U.S. CDC.

However, if you have been vaccinated for hepatitis A in the past, you do not need to receive another dose.

And if you have a child born after the year 2000, that child has likely already been vaccinated for hepatitis A and does not require another dose.

Last week, the hepatitis A vaccine clinics administered about 800 vaccinations to people in Camden County, NJ.

Previously, the Camden County Health Department was notified by a health care provider on Nov. 17, 2021, that a food handler employed at a Starbucks in Gloucester Township tested positive for hepatitis A and worked through the infectious period.

Hepatitis A is a contagious liver disease usually spread when a person ingests fecal matter, even in microscopic amounts, from contact with objects, food, or drinks contaminated by the feces of an infected person.

Hepatitis A symptoms can surface two to four weeks after exposure, although they can, in some instances, occur up to seven weeks after exposure. Children under six years of age with hepatitis A often do not show signs or symptoms.

For more information on hepatitis A and vaccine availability, patrons of Starbucks can contact the Camden County Health Department at (856) 549-0530 or their primary care physician.

Since 2016, CDC’s Division of Viral Hepatitis (DVH) has assisted multiple state and local health departments with hepatitis A outbreaks, spread through person-to-person contact.

Since the outbreaks began, 37 states have publicly reported the following data as of November 19, 2021

Cases: 42,936
Hospitalizations: 26,153 (61%)
Deaths: 402

The CDC has updated its overall recommendations on preventing hepatitis A virus infection in the United States.

A listing of FDA-authorized hepatitis A vaccines is located on this webpage.

PrecisionVaccinations publishes fact-check, research-based vaccine news.

Sub Title:

Free hepatitis A vaccinations available from Camden County Health Department

References:

Hepatitis A Clinic Scheduled for Wednesday

CDC: Widespread Outbreaks of Hepatitis A across the United States

Hepatitis Vaccines

North Carolina Confirms 495 Hepatitis A Cases

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Wednesday, November 24, 2021 - 05:45

Three Antigen Hepatitis B Vaccine Found Effective

Don Hackett — Tue, 19 Oct 2021 13:06:14 +0000

Reviewer:

Robert Carlson, MD

Massachusetts-based VBI Vaccines Inc. recently announced that Phase 3 study results of its prophylactic 3-antigen hepatitis B (HBV) vaccine candidate were published in The JAMA Network Open.

The CONSTANT study was designed to demonstrate manufacturing equivalence of three lots of VBI’s HBV vaccine candidate and evaluate the immunogenicity of VBI’s 3-antigen HBV vaccine candidate compared to a single-antigen HBV vaccine, Engerix-B®, after two and three doses, and safety and reactogenicity.

The primary endpoint of lot-to-lot manufacturing consistency, measured by GMC of anti-HBs concentration at Day 196 across three consecutively manufactured lots of VBI’s 3-antigen HBV vaccine candidate, was achieved.

And SPR after two doses, at Day 168, was 90.4% for VBI’s 3-antigen vaccine candidates compared to 51.6% for Engerix-B®, increasing to 99.3% and 94.8%, respectively, after the third dose.

The mean GMC of anti-HBs titers was more than 7.5x higher after two doses, at Day 168, and 3.5x higher after three doses, at Day 196 (5442.4 mIU/mL VBI vs. 1567.2 mIU/mL Engerix-B).

Furthermore, VBI’s 3-antigen vaccine also elicited a higher percentage of participants with anti-HBs titers ≥ 100 mIU/mL, a more stringent titer threshold, of 95.8% vs. 86.3% for Engerix-B at Day 196.

No safety signals were observed in either study arm, and no new safety risks were identified.

Together with results from the first pivotal Phase 3 study, PROTECT, these results formed the basis for the regulatory submissions of VBI’s 3-antigen HBV vaccine candidate in the U.S., Europe, and Canada.

This HBV vaccine is sold under the name Sci-B-Vac® in Israel.

Dr. Timo Vesikari, M.D., Ph.D., Professor Emeritus and Director of the Nordic Vaccine Research Network in Finland, principal investigator of the CONSTANT study, and author of the manuscript commented, commented in a related press statement issued on October 13, 2021, “In North America and Europe, adults age 25-49 years have the highest rates of HBV infection.”

“Unfortunately, it is also this population who has the lowest adherence rates to the full course of vaccination.”

“The data from this pivotal Phase 3 study have meaningful public health importance, demonstrating the ability of the 3-antigen HBV vaccine candidate to elicit high rates of seroprotection and increased antibody titers after both two and three doses in this population compared to the conventional, single-antigen HBV vaccine.”

“Moreover, these data add to the well-established safety profile of this vaccine.”

Hepatitis B is a vaccine-preventable liver infection caused by the hepatitis B virus, says the U.S. CDC.

Hepatitis B is spread when blood, semen, or other body fluids from a person infected with the virus enters the body of someone who is not infected. This can happen through sexual contact, sharing needles, syringes, or other drug-injection equipment, or from mother to baby at birth.

Not all people newly infected with HBV have symptoms, but symptoms can include fatigue, poor appetite, stomach pain, nausea, and jaundice for those who do.

For many people, hepatitis B is a short-term illness.

For others, it can become a long-term, chronic infection that can lead to serious, even life-threatening health issues like cirrhosis or liver cancer.

The risk for chronic infection is related to age at infection: about 90% of infants with hepatitis B develop chronic infection, whereas only 2%–6% of people who get hepatitis B as adults become chronically infected.

The best way to prevent hepatitis B is to get vaccinated, says the CDC.

Various HBV vaccines are listed on this webpage.

PrecisionVaccination publishes fact-checked research-based vaccine news.

Sub Title:

VBI’s 3-antigen hepatitis B vaccine is comprised of the S, pre-S1, and pre-S2 surface antigens of the HBV

References:

Immunogenicity and Safety of a 3-Antigen Hepatitis B Vaccine vs a Single-Antigen Hepatitis B Vaccine

Engerix-B Hepatitis B Vaccine

Sci-B-Vac Hepatitis B Vaccine

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Tuesday, October 19, 2021 - 05:45

North Carolina Confirms 495 Hepatitis A Cases

Don Hackett — Sun, 01 Aug 2021 17:42:44 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The North Carolina Department of Health and Human Services (NCDHHS) recently announced the state had surpassed 1,000 reported cases of hepatitis A associated with a national outbreak that began in April 2017.

In addition, NCDHHS confirmed 63% of patients had required hospitalization, and 16 people have died from hepatitis A.

Since January 2021, 495 outbreak-associated cases of hepatitis A were reported by NCDHHS, indicating a marked increase in virus transmission.

Of the 2021 cases, 13% are also infected with hepatitis B and 48% with hepatitis C.

During the outbreak, Kentucky (5,132) and Florida (5,089) have reported the most hepatitis A cases in the USA.

Because hepatitis A causes inflammation of the liver, people with other forms of viral hepatitis or anyone with underlying liver disease are at risk of more serious illness if infected.

Since the outbreak began in 2017, the U.S. CDC’s Division of Viral Hepatitis has received about 41,855 reports of hepatitis A and 382 related deaths as of July 23, 2021.

The hepatitis A vaccine is the best way to prevent HAV infection. One dose of single-antigen hepatitis A vaccine has been shown to control outbreaks of hepatitis A.

And, prevaccination serologic testing is not required to administer a hepatitis A vaccine. Vaccinations should not be postponed if vaccination history cannot be obtained or records are unavailable.

People at risk for acquiring HAV infection or developing serious complications from HAV infection during the current hepatitis A outbreaks should be prioritized to receive the hepatitis A vaccine as soon as possible to do so safely, says the CDC.

The risk for person-to-person transmission of HAV continues during the COVID-19 pandemic, says the CDC.

"The best way to protect yourself against hepatitis A is through vaccination," said Dr. Erica Wilson, vaccine-preventable disease medical director in NCDHHS’ Division of Public Health, in a press statement issued on July 27, 2021.

"As always, good hand-washing is key, especially after using the bathroom, changing diapers, and before preparing or eating food. Using harm reduction strategies and syringe service programs is also key in reducing the risk for people who use drugs."

An updated list of U.S. FDA Approved hepatitis vaccines and vaccine candidates is published on this webpage.

Hepatitis A is usually transmitted through food or water that has been contaminated with small, undetectable amounts of feces from a contagious person. Individuals who use drugs, are experiencing homelessness, or men who have sex with men are at the highest risk for infection during the current outbreak.

Symptoms of hepatitis A include fever, fatigue, nausea, loss of appetite, and stomach pain. Jaundice (yellowing of the skin and/or eyes), dark-colored urine, and clay-colored bowel movements may also occur.

These symptoms appear 15-50 days (average 28 days) following infection with the virus.

However, young children can be infected without apparent symptoms.

The NCDHHS advises anyone with symptoms of hepatitis A to contact their health care provider or their local health department to be tested and linked to care assistance.

In addition, anyone exhibiting these symptoms should refrain from preparing food for others. Patients can transmit the virus to others in the two weeks before and one week after jaundice appears.

People with severe underlying medical conditions, such as hepatitis A, may be at higher risk for severe illness from COVID-19. Additional co-administration information is available on this CDC webpage.

PrecisionVaccinations publishes fact-checked research-based news.

Sub Title:

Hepatitis outbreaks can be reduced with one dose of single-antigen hepatitis A vaccine

References:

CDC: Widespread outbreaks of hepatitis A across the United States

North Carolina Hepatitis A Outbreak Surpasses 1,000 Cases

Hepatitis Vaccines

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Monday, August 2, 2021 - 20:00

Hepatitis B Vaccine Delivered Positive Seroprotection Rate

Don Hackett — Mon, 11 Jan 2021 19:21:43 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

A California-based biopharmaceutical company announced immunogenicity and safety results of the ongoing clinical trial evaluating HEPLISAV-B®, a Hepatitis B Vaccine (HVB) in patients undergoing hemodialysis.

Dynavax Technologies Corporation published final immunogenicity data in 119 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) undergoing hemodialysis, demonstrated a seroprotection rate of 89.3 percent with high levels of anti-HBs antibodies, which are critical to maintaining protection in patients undergoing hemodialysis.

And, the interim safety data showed HEPLISAV-B was well tolerated, and no safety concerns were observed. Full safety data are expected by the end of 2021.

HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax's proprietary Toll-like Receptor (TLR) 9 agonist adjuvant CpG 1018 to enhance the immune response.

HEPLISAV-B is indicated to prevent infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

Robert Janssen, M.D., Chief Medical Officer at Dynavax, stated in a press release, "We believe the 4-dose regimen of HEPLISAV-B, we are evaluating in this study, can provide an important hepatitis B vaccination alternative for patients undergoing hemodialysis by delivering high levels of protection with fewer doses compared to the current standard of care which requires up to 8 injections to complete the regimen."

The study, HBV-24, is designed to evaluate the immunogenicity of HEPLISAV-B at study week 20 and safety over the 68-week study duration. The safety and effectiveness of HEPLISAV-B have not been established in adults on hemodialysis.

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. HBV is 50 to 100 times more infectious than HIV, and there is no cure for hepatitis B, says the U.S. CDC.

In adults, hepatitis B is spread through contact with infected blood and unprotected sex with an infected person. The CDC recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations, and travel to certain areas.

Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis. And for people age 60 and older with diabetes at their physician's discretion.

The company says, ‘do not administer HEPLISAV-B to individuals with a history of a severe allergic reaction after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast.

HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines.

PrecisionVaccinations publishes research-based vaccine news.

Sub Title:

Dynavax Technologies HEPLISAV-B is an adult hepatitis B vaccine

References:

Dynavax Announces Final Immunogenicity and Interim Safety Results from Clinical Trial Evaluating HEPLISAV-B in Patients Undergoi

CDC: Hepatitis

Heplisav-B Hepatitis B Vaccine

HEPLISAV-B® in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

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