Hepatitis B

Three Antigen Hepatitis B Vaccine Found Effective

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

Reviewer:

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

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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Multinational Phase 2 Clinical Trial Launches Novel Immunotherapeutic for the Treatment of Chronic Hepatitis B

Don Hackett — Wed, 30 Dec 2020 17:10:49 +0000

Reviewer:

Robert Carlson, MD

A Maryland-based biopharmaceutical company announced that it had enrolled the first patient in its multinational Phase 2 clinical trial of HepTcell, a novel peptide-based immunotherapeutic under development to treat chronic hepatitis B (CHB).

HepTcell is a novel immunotherapeutic composed of nine synthetic HBV-derived peptides formulated with IC31®, a TLR9-based adjuvant from Valneva SE. The HBV peptides are designed to drive T cell responses against all HBV genotypes in patients of diverse genetic backgrounds.

There is no cure for CHB, and currently, available antiviral medications only control the disease and require life-long treatment.

Altimmune, Inc. stated the study is being conducted in the USA, Canada, and Europe and is a double-blind, randomized, placebo-controlled study of 80 adult patients with HBeAg-negative inactive CHB and HBsAg ≤ 100 IU/mL.

HepTcell will be administered in 6 doses at 4-week intervals for 24 weeks, and patients will be followed for one year to evaluate the safety and durability of response.

“As one of the most common infectious diseases worldwide, there remains a significant unmet medical need for improved CHB therapies, as currently approved therapeutics prevent disease progression but rarely lead to a functional cure,” said Dr. Scott Harris, Chief Medical Officer of Altimmune, in a press release.

“We believe the T cell immune intolerance that characterizes the disease must be broken for the development of a functional cure. As a novel immunotherapeutic, HepTcell works by restoring dormant T cells to eliminate an infection.”

“While novel direct-acting agents under development, such as small inhibitory RNAs and capsid assembly modulators, have shown promise in reducing HBsAg load below 100 IU/mL, these agents have not resulted in the reactivation of T cell immunity and are unlikely to achieve durable virologic responses as monotherapies.”

“Based on the encouraging preclinical and clinical data, we are optimistic that HepTcell may be ideal in combination with novel direct-acting antivirals to achieve a functional cure for this disease.”

According to the World Health Organization estimates, CHB affects 292 million people worldwide, and nearly 900,000 people die annually of complications of the disease. If left untreated, CHB infection can lead to serious health issues, including cirrhosis, liver failure, and liver cancer.

Acute Hepatitis B infections are cleared through a T cell-dependent immune response. However, in chronically infected patients, high viral antigen load can induce a state of immune tolerance that prevents T cells from clearing the infection.

Restoring T cell function is considered essential to achieving a functional cure, defined as the loss of hepatitis B surface antigen (HBsAg) in the blood. Ultimately, all HBV therapeutics’ goal is to achieve a functional cure by reactivating the T cell immune response and overcoming immune tolerance.

In a Phase 1 clinical study of HepTcell conducted in the United Kingdom and South Korea, three monthly injections at two dose levels of HepTcell peptides were administered with and without IC31® adjuvant add-on therapy to entecavir or tenofovir in patients with Hepatitis B e-antigen (HBeAg)-harmful chronic infections.

In the Phase 1 study, all doses of HepTcell were generally well-tolerated. Both high and low doses of HepTcell given in combination with IC31® resulted in potent T cell responses against HBV antigens – representing a break in immune tolerance with no evidence of immune-mediated adverse events.

Altimmune is a clinical-stage biopharmaceutical company focused on developing intranasal vaccines, immune-modulating therapies, and liver disease treatments.

PrecisionVaccinations publishes research-based news.

Sub Title:

Altimmune, Inc. HepTcell is a novel peptide-based immunotherapeutic for chronic hepatitis B treatment

Reference:

Altimmune Begins Multinational Phase 2 Clinical Trial Of HepTcellTM, A Novel Immunotherapeutic For The Treatment Of Chronic HepB

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Hepatitis B Vaccine Competitors Face-Off

Don Hackett — Fri, 10 Jan 2020 17:31:50 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

A Massachusetts based biopharmaceutical company reported top-line data from CONSTANT, a 2nd pivotal Phase 3 clinical study, assessing lot-to-lot manufacturing consistency of Sci-B-Vac®, a trivalent hepatitis B (HBV) vaccine, and comparing safety and immunogenicity with Engerix-B®.

Francisco Diaz-Mitoma, M.D., Ph.D., VBI Vaccines’s Chief Medical Officer commented in a press statement on January 8, 2020, “With the completion of the pivotal Phase 3 program, we believe the full data package of Sci-B-Vac® supports its ability to address significant unmet medical needs in North America and in Europe.”

“As demonstrated in the pivotal Phase 3 program, Sci-B-Vac can safely confer higher rates of protection in older adults and in adults with key immuno-compromising conditions.”

“Moreover, in younger healthy adults who need protection safely and quickly, we believe Sci-B-Vac has demonstrated its ability to be highly competitive, achieving protection rates of 90 percent after 2 vaccinations and 99 percent after 3 vaccinations.”

The CONSTANT study is a double-blind, four-arm, randomized, controlled study that enrolled 2,838 adult subjects, age 18-45 years, who were randomized in a 1:1:1:1 ratio into one of four three-dose cohorts: Lot A of Sci-B-Vac 10 µg, Lot B of Sci-B-Vac 10 µg, Lot C of Sci-B-Vac 10 µg, or the control vaccine Engerix-B 20 µg. Under the planned dosing schedule, subjects were vaccinated at months zero, one, and six.

The primary endpoint of this study was:

To demonstrate lot-to-lot consistency for immune response, as measured by geometric mean concentration (GMC) of antibodies across three independent, consecutive lots of Sci-B-Vac four weeks after the third vaccination.
This primary endpoint was prospectively defined across two patient sets, with a demonstration of lot-to-lot consistency required in only one of the two sets – the detailed study results will be discussed with the FDA as part of the regulatory approval process

The secondary endpoints were to evaluate the safety and efficacy of Sci-B-Vac vs. Engerix-B.

Together with the positive safety and immunogenicity results of the PROTECT Phase 3 study – data which were announced in June 2019 – these data comprise the basis for the regulatory submissions in the U.S., Europe, and Canada, expected to begin in the second half of 2020.

A secondary endpoint of the study was non-inferior immunogenicity as measured by seroprotection rates (SPR) at day 196, one month after completion of the full course of vaccination with either Sci-B-Vac or Engerix-B.

At day 196, the pooled SPR in subjects who received Sci-B-Vac was 99.3% compared to 94.8% for those who received Engerix-B – a difference of 4.49%; 95% Confidence Interval (CI) [2.90%, 6.63%] – up from 90.4% for Sci-B-Vac and 51.6% for Engerix-B at day 168, after only 2 vaccinations.

In addition to demonstrating non-inferiority, the SPR achieved with Sci-B-Vac compared with Engerix-B was higher after both two and three vaccinations.

The safety and tolerability seen in CONSTANT were consistent with the known safety profile of Sci-B-Vac. No new safety risks were identified and no safety signals were observed in either cohort. The integrated safety data analysis from both the PROTECT and CONSTANT studies is underway.

An exploratory analysis in CONSTANT also compared the SPR after two doses of Sci-B-Vac (at day 168) to the SPR after three doses of Engerix-B (at day 196).

At these times points, the SPR was 90.4% for Sci-B-Vac and 94.8% for Engerix-B – a difference of -4.3%; 95% CI [-6.48%, -1.90%].

As per the commonly-used statistical margin of non-inferiority for vaccines1, defined as the lower limit of the 95% CI being above -10%, this analysis demonstrated non-inferiority after two doses of Sci-B-Vac (at day 168) compared with three doses of Engerix-B (at day 196).

Similarly, at these time points, preliminary data from the integrated immunogenicity analysis of both the PROTECT and CONSTANT studies in subjects age 18-45 years demonstrate a difference in SPR of -4.2%; 95% CI [-6.38%, -1.99%].

The 2 vs. 3-dose comparison is not part of the regulatory approval process and would not be included in the expected indication the company will seek, but does contribute to the robust immunogenicity profile of Sci-B-Vac.

Vaccine development news published by Precision Vaccinations.

Sub Title:

VBI Vaccines hepatitis B vaccine Sci-B-Vac reports protection in older adults and in adults with key immuno-compromising conditions

References:

VBI Vaccines Announces Second Pivotal Phase 3 Study of Sci-B-Vac® Meets Primary and Secondary Endpoints

Sci-B-Vac vs. Engerix-B in a Phase 3 Comparison

Sci-B-Vac Hepatitis B Vaccine

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GoodRx Vaccine:

Engerix-B

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Hepatitis B & D: Partners in Liver Damage

Don Hackett — Sun, 22 Dec 2019 13:25:12 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

A new study published by a team of Canadian researchers adds insights into how 2 types of hepatitis work together to negatively impact a human’s liver.

Located in Montreal, Canada, at the Institut National de la Recherche Scientifique (INRS), Professor Patrick Labonté and the team say they ‘have identified the role of a key process in the replication cycle of the hepatitis D virus.’

This is important news since the hepatitis D virus (HDV), also known as delta hepatitis, affects 15 to 20 million people worldwide.

To cause liver damage, HDV has a specific target. it infects only people carrying the hepatitis B virus (HBV).

As with other co-infections, the combination of hepatitis B and D causes more liver damage than hepatitis B alone.

"HDV needs HBV to survive, it's like a parasite," says researcher Patrick Labonté, in a related press release published on December 19, 2019.

According to the World Health Organization (WHO), at least 5 percent of people with chronic HBV infection are also infected with HDV. And, HBV-HDV co-infection is the most severe form of chronic viral hepatitis because it progresses very quickly and can even be fatal.

“However, cure rates are low because treatments for hepatitis B are ineffective against HDV. It may seem contradictory since the virus cannot survive on its own.”

"In fact, drugs target a specific enzyme to control hepatitis B, but treatment does not completely eliminate the virus. The VHD survives normally and can continue its damage,” said Professor Labonte.

The challenge for Professor Labonté and his research team is thus to find a treatment that will fight both viruses and it seems they are on the right track.

In a study published in the Journal of Virology on November 20, 2019, the research team showed that VHD was exploiting the same cellular protein as HBV, called ATG5, to promote its development, particularly its replication in the nucleus of the host cell.

This protein is essential for what is called autophagy; a process that is used for cleaning cellular waste. In theory, autophagy should be able to destroy invaders, but most viruses, such as hepatitis C or influenza, have evolved to avoid this degradation and even use autophagy to their advantage.

"Several studies have looked at the role of autophagy in viruses, but it varies from one virus to another depending on its replication process. We are the first to determine the effect of the process on the hepatitis D virus," says Professor Labonté.

He was not surprised that ATG5 protein benefits these two hepatitis viruses since they are closely linked.

With this common protein, the autophagic process could be a solution since it is essential to the life cycle of these viruses.

However, the situation is not that simple.

"If we block autophagy, then we are blocking an important function for all cells in the body. We do not know what the long-term effects might be. Autophagy should be inhibited in a targeted and temporary manner," warns Professor Labonte.”

"Hepatitis B virus alone can cause cirrhosis or liver cancer. When combined with the hepatitis D virus, the development of these diseases happens more frequently and more rapidly," he says.

In the course of this research, Professor Labonté;'s team made an interesting discovery: some autophagy proteins travel outside their usual area.

"Autophagy usually occurs in the cell's cytoplasm, but the process contributes to the replication of the HDV genome which takes place in the nucleus. Are there any autophagic proteins present in the nucleus in the case of an infection,” wondered the researcher.

This is an area that the team is currently studying and will hopefully provide a more in-depth understanding of the role of autophagy in HDV.

Hepatitis D is transmitted to humans through percutaneous or mucosal contact with infectious blood and can be acquired either as a coinfection with HBV or as a superinfection in people with HBV infection, says the US Centers for Disease Control and Prevention (CDC).

There is not a CDC approved a vaccine for hepatitis D, but it can be prevented in people who are not already HBV-infected, by hepatitis B vaccination.

Recent hepatitis vaccine news

In the USA, there are 3 single-antigen vaccines and 2 combination HBV vaccines available:

Single-antigen hepatitis B vaccines: ENGERIX-B, RECOMBIVAX HB, and HEPLISAV-B

HBV combination vaccines include PEDIARIX and TWINRIX.

This research was supported by funding from the Natural Sciences and Engineering Research Council of Canada (NSERC).

The Institut national de la recherche Scientifique is the only institution in Québec dedicated exclusively to graduate-level university research and training.

Hepatitis vaccine news published by Precision Vaccinations

Sub Title:

ATG5 protein benefits both hepatitis B and D viruses to utilize the autophagy machinery to assist at different steps of their lifecycle

References:

HDV alters the autophagy process to promote its genome replication

Hepatitis D: Mystery of the Life Cycle of the Solved Virus

Host Cell Rab GTPases in Hepatitis B Virus Infection

CDC: What is Viral Hepatitis?

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GoodRx Vaccine:

Engerix-B

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Hepatitis B Vaccine Reports Similar Acute Myocardial Infarction Rate

Don Hackett — Tue, 03 Dec 2019 21:43:54 +0000

Reviewer:

Danielle Reiter, RN

Robert Carlson, MD

A California based biopharmaceutical company announced that it has filed a report on a cumulative analysis of its post-marketing study of the Hepatitis B Vaccine HEPLISAV-B for review by the U.S. Food and Drug Administration (FDA).

This Dynavax Technologies Corporation study is assessing the rates of occurrence of acute myocardial infarction (AMI) in persons receiving HEPLISAV-B compared with Engerix-B.

The interim report assessed unadjudicated events of AMI. The event rates in this interim analysis were found to be similar between the 2 treatment arms.

And, the independent data monitoring committee concurred that this analysis showed no evidence of an increase in AMI events in the HEPLISAV-B arm.

The study was initiated in August 2018 and will continue through November 2020. Final study results will be reported upon study completion.

This post-marketing study requirement is related to FDA approval of HEPLISAV-B on November 9, 2017.

“These results reinforce our previous clinical data regarding the safety of HEPLISAV-B and support our confidence that HEPLISAV-B can be the emerging standard of care for preventing hepatitis B infection in adults,” commented Robert Janssen, M.D., Chief Medical Officer, in a related press release.

“We are pleased to collaborate with Kaiser Permanente Southern California for their rigorous conduct of this study, and look forward to a scientific presentation of the final data at an appropriate forum in the future.”

Dynavax previously announced the complete accrual of more than 30,000 patients who received HEPLISAV-B and more than 30,000 patients who received Engerix-B in the ongoing post-marketing study.

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

Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer, and death. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person.

The most common patient-reported adverse reactions reported within 7 days of vaccination were injection site pain (23%-39%), fatigue (11%-17%), and headache (8%-17%). And, 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.

The Centers for Disease Control and Prevention (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 years with diabetes as soon as possible after their diagnosis, and for people age 60 years and older with diabetes at their physician's discretion.

Dynavax is a commercial-stage biopharmaceutical company developing and commercializing novel vaccines. For more information, visit www.dynavax.com.

Hepatitis B vaccine news published by Precision Vaccinations

Sub Title:

Dynavax HEPLISAV-B hepatitis B vaccine completes post marketing study

References:

Dynavax Announces HEPLISAV-B Post-Marketing Requirement Interim Report Completed

FDA: BLA APPROVAL

Safety and Immunogenicity Study of the Hepatitis B Vaccine, HEPLISAV™, Compared to Engerix-B® Vaccine

CDC: Hepatitis B Questions and Answers for the Public

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Hepatitis B Vaccine Candidate Doses 1st Patient

Don Hackett — Fri, 15 Nov 2019 17:14:19 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Two vaccine companies announced the 1st patient was dosed in a Phase 1b/2a proof-of-concept clinical study of BRII-179 (VBI-2601), a novel recombinant, protein-based immuno-therapeutic candidate, for the treatment of chronic hepatitis B virus (HBV) infection.

This is important news as HBV infections are a leading cause of liver disease and, with current treatments, it is very difficult to cure, with many patients going on to develop liver cancers.

In 2017, there were 1,727 death certificates among USA residents that listed hepatitis B as the underlying or a contributing cause of death.

Information from this new study is expected in the second half of 2020, said VBI Vaccines Inc. and Brii Biosciences, in a November 14, 2019, press release.

“Chronic HBV has long been considered one of the most challenging viral infections to treat, due to its complex life cycle once it takes hold in the liver,” said Jeff Baxter, President, and CEO of VBI.

“There is growing consensus in the scientific community that a functional cure for HBV is possible and that it will require restoration of HBV immunity to ensure the body’s own ability to control the viral infection.”

“We believe BRII-179 (VBI-2601) has the potential to be a critical and differentiated component of a functional cure for HBV,” concluded Baxter.

The company says ‘BRII-179 (VBI-2601) is uniquely formulated to target both B-cell and T-cell immunity through multiple mechanisms of action, including neutralizing the circulating hepatitis B virus, blocking hepatitis B infection of hepatocytes mediated through Pre-S1, and enabling immune-mediated clearance of HBV-infected hepatocytes.’

Where many investigational agents work inside the infected liver cells downstream of transcription, BRII-179 (VBI-2601) is designed to impact the key extracellular steps in the HBV lifecycle in order to restore immunologic control over the infection.

Hepatitis B is one of the world’s most significant infectious disease threats with more than 290 million people infected globally. An estimated 780,000 people die each year from complications of chronic HBV such as liver decompensation and hepatocellular carcinoma, says the US Centers for Disease Control and Prevention (CDC), last updated on November 8, 2019.

Chronic hepatitis B infections primarily occur (75%) among persons born outside the US in countries with intermediate or high rates of hepatitis B prevalence.

Excluding case reports with unknown or missing data, about 58 percent of chronic HBV infections were among Asian/Pacific Islanders.

Recent Hepatitis B vaccine news

September 19th, 2019 – A new analysis of Hepatitis B virus (HBV) status among women of childbearing age found increasing infection rates in Mississippi, Kentucky, and West Virginia.
June 19, 2019 – A new study reported that an HBV infection was associated with the risk of non-liver cancer, especially digestive system cancers. This study was published in JAMA on June 14, 2019, concluded that hepatitis B surface antigen (HBsAg) seropositivity was associated with the risk of hepatocellular carcinoma, stomach cancer, colorectal cancer, oral cancer, pancreatic cancer, and lymphoma.

The CDC continues to say the ‘best way to prevent hepatitis B is by getting vaccinated. The hepatitis B vaccine is safe and effective. Completing the series of shots is needed for full protection.’

In the USA, there are 3 single-antigen vaccines and 2 combination HBV vaccines available:

Single-antigen hepatitis B vaccines: ENGERIX-B, RECOMBIVAX HB, and HEPLISAV-B
HBV combination vaccines include PEDIARIX and TWINRIX

Additionally, the CDC is sharing this 5-minute online assessment which offers a personalized report on hepatitis testing and vaccination recommendations.

This Phase 1b/2a clinical study of BRII-179 (VBI-2601) is designed as a 2-part dose-escalation study assessing different dose levels of BRII-179 (VBI-2601) and is expected to enroll up to 65 patients. Brii Bio will conduct the study at multiple study sites in New Zealand, Australia, Thailand, South Korea, Hong Kong SAR, and China.

VBI is a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines. And, Brii Bio is a clinical-stage company committed to serving patients’ needs and improving public health in China and around the world.

Hepatitis vaccine information published by Precision Vaccinations

Sub Title:

VBI Vaccines BRII-179 (VBI-2601) is formulated to target both B-cell and T-cell immunity through multiple mechanisms of action

References:

VBI Vaccines and Brii Biosciences Initiate Phase 1b/2a Study of BRII-179 (VBI-2601) in Patients with Chronic Hepatitis B

CDC: Hepatitis B

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GoodRx Vaccine:

Engerix-B

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South Jersey’s Hepatitis A Outbreak Moves North

Don Hackett — Sat, 09 Nov 2019 15:32:48 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

According to updated information from the New Jersey Department of Health (NJDOH), the ongoing Hepatitis A outbreak in the Garden State has been centered in several southwest counties, located east of Philadelphia, PA.

On November 2, 2019, NJDOH reported Camden County had confirmed (140) cases associated with the current Hepatitis A outbreak, along with Gloucester (62), Mercer (49) and Burlington (39) counties.

These southern counties represent about 53 percent of the Hepatitis A cases confirmed in NJ since the outbreak began during December 2018.

Furthermore, these NJ counties are located adjacent to Pennsylvania, which previously declared a hepatitis A outbreak on May 20, 2019. Pennsylvania has reported 614 cases during the current outbreak.

And the recent NJDOH Alert indicates this Hepatitis A outbreak may soon accelerate in northern NJ.

As of November 8, 2019, the Somerset County Department of Health has already conducted 3 Hepatitis A vaccination clinics in Somerville, New Jersey.

These vaccination clinics are for individuals who may have eaten items purchased at the in-store deli department or used the restrooms at the ShopRite of Somerville, between October 13 to 30, 2019.

To be effective, the hepatitis A vaccine should be received as soon as possible, but no later than 2-weeks after eating food from this deli. For most people living n central NJ, this date would be Nov. 13, 2019.

This is not the 1st health alert in central NJ.

During October, the NJDOH issued a warning to Paterson, NJ residents when a food handler at Brother’s Produce on East Railway Avenue tested positive for the Hepatitis A disease.

And previously, the Morris County Office of Health Management confirmed 27 people contracted Hepatitis A from an infected food handler at the Mendham Golf & Tennis Club, likely between June 9 and June 30, 2019.

The recent Somerset County vaccination clinics are located about 43 miles west of New York City, which has yet to declare a Hepatitis A outbreak. NYC’s health department is working with other city agencies to help vaccinate at-risk populations, including, but not limited to the homeless.

But, during 2013, the New York City Department of Health and Mental Hygiene received reports of 6 hepatitis A cases among food handlers.

As of November 4th, the Centers for Disease Control and Prevention (CDC) have not reported any Hepatitis A cases in the state of New York during 2019. Since the outbreaks were first identified in 2016, 30 states have publicly reported 27,634 cases to the CDC.

Hepatitis A is a contagious liver infection caused by a virus. It can range from a mild infection with no symptoms lasting a few weeks to a severe illness lasting several months that can result in liver failure and death, says the NJDOH.

Immunocompromised persons – those with weakened immune systems – should talk with their healthcare provider about getting immunoglobulin or Ig instead of the vaccine.

If you believe you were exposed you should stay at home and contact your healthcare provider immediately if symptoms of hepatitis A infection develop. There is no treatment for hepatitis A once symptoms appear.

Symptoms of Hepatitis A can include; fatigue, sudden nausea, and vomiting, abdominal pain or discomfort, especially on the upper right side beneath your lower ribs (by your liver), clay-colored bowel movements, loss of appetite, low-grade fever, dark urine, and/or joint pain.

People with Hepatitis A should also avoid taking drugs that can hurt their liver, such as acetaminophen or Tylenol, says NJDOH.

> Confidential Hepatitis A Tests <

Since March 2017, CDC’s Division of Viral Hepatitis has been assisting multiple state and local health departments with hepatitis A outbreaks, spread through person-to-person contact.

The 3 largest groups affected by the ongoing, multi-state, Hepatitis A virus outbreak are intravenous drug users, the homeless, and men who have participated in sexual intercourse with other men.

Additionally, food-service workers represent another sizable, at-risk population since their daily responsibilities include directly handling food and drink, said the CDC.

There is also an overlap between intravenous drug users and part-time food-service workers in some communities.

According to previous studies, the restaurant segment of the food-service industry has a long, sordid relationship with substance abuse and substance abuse disorders.

In 2015, a study conducted by The Substance Abuse and Mental Health Administration found the food services and hospitality industry to have the highest rates of substance use disorders of all employment sectors.

Fortunately, one national restaurant chain has just announced a significant effort that may reduce hepatitis A cases in its staff.

Starbucks is installing needle-disposal boxes in some bathrooms, as well as exploring other solutions to workers' concerns regarding improperly discarded syringes and the related health risks.

Hepatitis A vaccine news

Protective anti-hepatitis A virus antibody levels after a single dose of inactivated hepatitis A vaccine is considered to be up to 95 percent effective and offer protection for up to 11 years, says the CDC.

There are 3 HAV vaccines approved in the USA: Vaqta, Havrix, and Twinrix, which are available at most pharmacies in NJ. And, immune globulin can provide short-term protection against hepatitis A, both pre- and post-exposure.

In NJ, accessing 317 Funds as part of the Hepatitis A outbreak response is potentially available to qualifying individuals.

Section 317 of the Public Health Services Act authorizes the federal purchase of vaccines. In NJ, those priority populations are uninsured and underinsured adults for routine vaccines and any at-risk populations during an outbreak response.

Additional vaccine discounts can be found here.

Answers to frequently asked questions about hepatitis A are available at NJDOH.

The CDC says any vaccine can cause side effects, which should be reported to a healthcare provider asap.

Hepatitis A vaccine news published by Precision Vaccinations.

Sub Title:

CDC confirms 275 hepatitis A virus related fatalities since 2016

References:

Accessing and Using 317 Funds for Hepatitis A Vaccination as Part of the Hepatitis A Outbreak Response

22 people caught Hepatitis A in outbreak at N.J. golf club, officials say

Department of Health Declares Hepatitis A Outbreak

CDC: Widespread person-to-person outbreaks of hepatitis A across the United States

CDC: Outbreak-specific considerations for hepatitis A vaccine administration

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Hepatitis B Immunity Among Women of Childbearing Age Decreased in 3 States

Don Hackett — Thu, 19 Sep 2019 17:50:04 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

A new analysis of Hepatitis B virus (HBV) status among women of childbearing age found increasing infection rates in Mississippi, Kentucky, and West Virginia.

This study published on August 29, 2019, reported these 3 states had a declining prevalence of HBV seroprotection over the past few years, especially within the ‘birth-cohort.’

This is not good news, since a chronic hepatitis B infection can be treated and managed clinically, but cannot be cured.

In 2017, there were 1,727 death certificates among US residents that listed hepatitis B as the underlying or a contributing cause of death.

These trends in new HVB infections may be related to increased injection drug use and highlight potential gaps in HBV vaccine protection in certain states.

The good news from this analysis is the national rate of acute HBV infections was decreasing.

The prevalence of new chronic HBV diagnoses decreased significantly from (0.83%) to (0.19%) from 2011 to 2017.

On September 19, 2019, the Centers for Disease Control and Prevention (CDC) reported Hepatitis B often occurs as an acute infection that may or may not be identified or reported.

In 2016, there were 3,218 HBV cases reported to the CDC. After adjusting for under-ascertainment and under-reporting, the estimated number of new HBV infections in 2016 was actually 20,900.

And, 17 states notified the CDC of perinatal hepatitis B cases, up from 13, in 2016.

Hepatitis B is a vaccine-preventable disease and reported cases of acute hepatitis B declined from 1990–2014 after routine vaccination of children was recommended.

Chronic hepatitis B infections primarily occur (75%) among persons born outside the US in countries with intermediate or high rates of hepatitis B prevalence.

Excluding case reports with unknown or missing data, about 58 percent of chronic HBV infections were among Asian/Pacific Islanders.

Moreover, the CDC’s mortality data shows that disproportionate numbers of Asian/Pacific Islanders are dying with hepatitis B.

To address this serious issue, the CDC and the U.S. Preventive Services Task Force (USPSTF) recommend HBV testing for persons born in countries where HBV infection is endemic.

During August 2019, the USPSTF reaffirmed its previous conclusion that there is convincing evidence that screening for the HBV infection in pregnant women provides substantial benefit.

This USPSTF statement means ‘testing for the hepatitis B surface antigen (HBsAg) should be ordered at the 1st prenatal visit.’

Additionally, women with unknown HBsAg status or with new or continuing risk factors for a viral infection of the liver should be screened at the time of admission to a hospital or other delivery setting, says the USPSTF.

Furthermore, the USPSTF found adequate evidence that vaccination of all infants against HBV infection and providing postexposure prophylaxis with hepatitis B immune globulin (HBIG) at birth to infants of mothers infected with HBV substantially reduce the risk for acquisition of HBV infection in infants.

>> Private hepatitis screening at Ulta Labs <<

The CDC said on July 3, 2019, the ‘best way to prevent hepatitis B is by getting vaccinated. The hepatitis B vaccine is safe and effective. Completing the series of shots is needed for full protection.’

In the USA, there are 3 single-antigen vaccines and 2 combination HBV vaccines available:

Single-antigen hepatitis B vaccines: ENGERIX-B, RECOMBIVAX HB, and HEPLISAV-B
HBV combination vaccines include PEDIARIX and TWINRIX

To schedule a vaccination appointment at a local healthcare provider, please click here. And, vaccine financial support programs can be found at Vaccine Discounts.

Hepatitis B vaccine news

Additionally, the CDC is sharing this 5-minute online assessment which offers a personalized report on hepatitis testing and vaccination recommendations.

Hepatitis Vaccine information published by Precision Vaccinations

Sub Title:

Kentucky, Mississippi, and West Virginia found newly diagnosed acute and chronic HBV infection increased significantly

References:

Trends in Hepatitis B Infection and Immunity among Women of Childbearing Age in the United States

CDC: Surveillance for Viral Hepatitis – United States, 2017

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Adult Immunization Schedule Updated

Don Hackett — Wed, 21 Aug 2019 20:25:39 +0000

Every year in the United States, thousands of adults become seriously ill and are hospitalized because of diseases that vaccines can help prevent.

The need for vaccines does not go away with age. In fact, there are specific ages in your adult life when vaccinations are recommended.

Immunization guidelines for adults are routinely updated when the US Food and Drug Administration (FDA) makes changes.

According to a JAMA article published on August 19, 2019, there have been 2 important vaccines approved by the FDA for adults, which are as follows:

Shingrix

Shingrix, a herpes zoster vaccine containing a specific protein subunit of the virus (recombinant glycoprotein E) with a novel adjuvant (an added substance that enhances or prolongs the immunologic response). Shingrix, a new recombinant herpes zoster vaccine approved by the FDA on October 20, 2017, is more efficacious than the older live-attenuated Zostavax (efficacy of >90% vs 51%, respectively).
The ACIP recommends Shingrix over Zostavax for all immunocompetent persons, for those with chronic medical conditions (eg, chronic kidney disease, diabetes, chronic lung disease), and for persons aged 50 years or older receiving low-dose immunosuppressive therapy (at 0 months and at 2-6 months), including those who previously received Zostavax (at ≥2 months after dose) or had a prior episode of shingles.
A recent study showed Shingrix reduced the incidence of herpes zoster in adults who had undergone autologous hematologic stem cell transplantation. Testing for varicella-zoster antibody prior to vaccination is not recommended.

Heplisav-B

Heplisav-B, a single-antigen recombinant hepatitis B vaccine with a novel adjuvant. In 2017, the recombinant hepatitis B vaccine (HBV), Heplisav-B, was approved by the FDA for adults aged 18 years or older.
It is a combination of HBV surface antigen (HBsAg; 20 µg) and Dynavax’s proprietary TLR9 agonist (a synthetic cytidine-phosphate-guanosine oligonucleotide, CpG 1018 adjuvant) and was designed to stimulate a directed immune response to HBsAg.
Heplisav-B is administered as a 2-dose series at 0 month and at 1 month. Currently, the ACIP does not endorse one hepatitis B vaccine over another; however, Heplisav-B requires only 2-doses and evidence suggests it is more immunogenic.

The vaccines you need as an adult are determined by many factors including your age, lifestyle, health condition, and which vaccines you’ve received during your life.

The 2019 adult vaccination schedule can be found here.

The FDA says ‘talk to your healthcare professional about which vaccines are right for you.’

The corresponding author for this JAMA article is Beverly E. Sha, MD, Rush University Medical Center, Division of Infectious Diseases, 600 S Paulina, Ste 140-143, Chicago, IL 60612 (beverly_sha@rush.edu).

Sub Title:

Shingrix and Heplisav-B vaccines now recommended for adults

Reference:

Adult Immunization Update

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Protecting Pregnant Women & Infants With Hepatitis B Vaccines

Don Hackett — Thu, 01 Aug 2019 19:10:24 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

John Paul Sanchez, PharmD

The US Preventive Services Task Force (USPSTF) reaffirmed its previous conclusion that there is convincing evidence that screening for the Hepatitis B virus (HBV) infection in pregnant women provides substantial benefit.

This USPSTF statement was published on July 30, 2019, saying there is adequate evidence that serologic testing for hepatitis B surface antigen accurately identifies HBV infections.

This means testing for the hepatitis B surface antigen (HBsAg) should be ordered at the 1st prenatal visit.

And, the USPSTF found limited evidence on the harms of screening for HBV infection in pregnant women. But, the potential harms of HBV screening is small based on the high accuracy of screening and the low likelihood of harms from preventive interventions.

In addition, there is evidence that over time, a perinatal transmission has decreased among women and infants enrolled in case-management, providing an overall substantial health benefit.

This new USPSTF statement is important since in the USA, estimates of chronic HBV infection range from approximately 850 ,000 to more than 2 million cases. In 2016, a total of 3,218 cases of acute hepatitis B were reported to the US Centers for Disease Control and Prevention (CDC).

In the United States, the most prevalent cases of HBV infection are chronic infections from exposure occurring in infancy or childhood.

>> Private hepatitis screening at Ulta Labs <<

Another major risk factor for HBV infection is country of origin. In the United States, adults with HBV born in high-prevalence countries were commonly infected during birth.

In US-born children, the primary source of infection is vertical transmission at birth. According to the CDC, 800 to 1000 cases of perinatal transmission (3.8% of infants born to HBV-positive women) occurred yearly from 2000 to 2009.

Since 1998, rates of maternal HBV infection have increased annually by 5.5 percent. Older maternal age, race/ethnicity (non-Hispanic black and Asian populations), lower education, higher poverty levels, and lack of insurance coverage are risk factors for HBV infection among women.

Persons infected with HBV during infancy or childhood are more likely to develop chronic HBV infection and have poor long-term health outcomes compared with persons infected later in life.

Acute HBV infections progress to chronic disease in 80 to 90 percent of infected infants, 30 percent of acute infections progress before age 6 years, and less than 1 to 12 percent of acute infections progress in older children or adults.

Hepatitis B vaccine news

“Hepatitis isn’t a disease we hear about often, but it’s still prevalent despite being preventable. Hepatitis B vaccinations are recommended for children, but adults that did not receive the vaccines in childhood may still be at risk,” said Holly Hawbaker, Pharm D Candidate, Intern for Brookshires Grocery Company.

“Patients should talk to their doctor or pharmacist to determine if they’re at risk for hepatitis, and if they are, they can receive the appropriate hepatitis vaccine.”

The CDC is sharing this 5-minute online assessment which offers a personalized report on hepatitis testing and vaccination recommendations.

The CDC said online on July 3, 2019, the ‘best way to prevent hepatitis B is by getting vaccinated. The hepatitis B vaccine is safe and effective. Completing the series of shots is needed for full protection.’

In the USA, there are 3 single-antigen vaccines and 2 combination HBV vaccines available:

Single-antigen hepatitis B vaccines: ENGERIX-B, RECOMBIVAX HB, and HEPLISAV-B

Combination vaccines: PEDIARIX and TWINRIX

To schedule a vaccination appointment at a local healthcare provider, please click here. And, vaccine financial support programs can be found at Vaccine Discounts.

Any vaccine can cause a side effect, which should be reported to a healthcare provider or the CDC.

Sub Title:

Hepatitis B virus vaccines stimulate natural immune systems to protect against the virus

References:

Hepatitis B Virus Infection in Pregnant Women: Screening

Screening for Hepatitis B Virus Infection in Pregnant Women US Preventive Services Task Force Reaffirmation Recommendation

CDC:Hepatitis B Questions and Answers for the Public

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Featured:

Various Ohio Restaurants Contributed to the Hepatitis A Outbreak

Don Hackett — Fri, 26 Jul 2019 19:48:51 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

John Paul Sanchez, PharmD

Kelley Lu, PharmD

Since the nationwide hepatitis A outbreak was first identified in 2016, 25 states have reported 22,295 cases and 216 related fatalities to the Centers for Disease Control and Prevention (CDC), as of July 19, 2019.

And one state has become the unfortunate outbreak leader during the April-July timeframe. As of July 22, 2019, the ‘Buckeye State’, Ohio has reported 3,220 hepatitis A cases.

In Columbus, Ohio, the City Health Commissioner Dr. Mysheika Roberts said ‘the number of Hepatitis A cases is skyrocketing. As of July 22, 2019, there were 458 hepatitis A cases reported in Columbus & Franklin Counties.’

“As the summertime festival season kicks off, I tell people whenever they are partaking of festival foods or things of that nature, they need to do a few basic things. One is they always have to make sure they wash their hands or have hand sanitizer available."

Dr. Roberts previously said on May 20, 2019, people need to ‘look for a little green sign on restaurant doors and windows, which means the place has met the health standards of Columbus Public Health.’

A partial list of Ohio restaurants reporting hepatitis A cases during 2019 are listed below:

July 5, 2019, a case of hepatitis A was identified in a Rally’s restaurant employee working in Springfield, according to the Clark County Combined Health District. However, due to safe food handling procedures, the risk of transmission to patrons at Rally’s is low, a statement from the health district said in a press release.
April 22, 2019, Columbus Public Health officials said 13 local restaurants had employees who contracted a Hepatitis A infection since an outbreak started in June 2018, but the agency only alerted the public about two restaurants. Health officials said there were minimal risks with the other 11 restaurants and that's why the public was not notified.
April 17, 2019, the Cincinnati Health Department learned today of a possible hepatitis A exposure at a local restaurant. People who ate at the US Chili restaurant (Colerain Avenue) between March 28 and April 6, may have been exposed to hepatitis A from an ill worker. While we believe that there is a minimal risk of exposure to the hepatitis A virus, out of an abundance of caution, the Cincinnati Health Department is notifying the public so they can assess their risk of exposure. US Chili has been fully cooperating with the Cincinnati Health Department in this investigation.
April 10, 2019, Butler County health workers urged restaurants to require vaccinations of their staff and doctors to recommend the inoculations to all patients. Bailer said some restaurants with corporate ownership changed policies and now require new employees to get vaccinated before starting work, reported Cincinnati.com.
March 26, 2019, a case of hepatitis A was identified in a Frisch’s restaurant employee that worked in 2 locations: Urbana and Springfield. The Champaign Health District and the Clark County Combined Health District are working with the locations to vaccinate all of the restaurant employees. In this situation, the risk of transmission to patrons is extremely low due to safe food handling procedures being in place. A spokesperson from Frisch’s issued a statement saying, “We have fully cooperated with Health Department authorities, and appreciate their ongoing work in addressing this nationwide issue. The well-being of our guests and team members remains our paramount concern.”
February 28, 2019, the Preble County Public Health Department released a notice stating that an employee at the KFC restaurant in Eaton, Ohio, was diagnosed with hepatitis A. The government says that anyone who ate there from February 9 through February 20, 2019, may have been exposed to the virus, although the risk of developing hepatitis A from this exposure is very low.
February 27, 2019, Frisch’s Restaurants paid to have their employees vaccinated in Franklin and Middletown after it was notified about employees with hepatitis A, said Warren County Health Commissioner Duane Stansbury, according to WCPO.
January 10, 2019, Clermont County Public Health identified a 2nd case of the hepatitis A virus in an employee of a Clermont County restaurant. Health departments are urging people who visited these restaurants to get vaccinated. “The restaurant management has been very cooperative and we are working with them to review safe food handling techniques,” said Assistant Health Commissioner Tim Kelly.

Recently, a study published in June 2019, investigated where and under what circumstances patients receive hepatitis A vaccination. This study found physician recommendations have been a top influencer of decisions to receive hepatitis A vaccinations.

“In the context of enhancing patient care, our results underscore the need of increasing awareness among primary care providers of the Advisory Committee on Immunization Practices (ACIP) recommendations for vaccinating adults at increased risk for hepatitis A infection,” according to a statement from this research team.

“The CDC recommends the use of evidence-based strategies, such as provider reminder/recall systems, standing orders and provider education programs, to reduce missed opportunities to vaccinate eligible persons,” the research team said.

Additionally, food-service workers represent another sizable, at-risk population since their daily responsibilities include directly handling food and drink, says the CDC.

According to previous studies, the restaurant market segment of the food-service industry has significant challenges. As an example, a 2015 study conducted by The Substance Abuse and Mental Health Administration, found the food services and hospitality industry to have the highest rates of substance use disorders of all employment sectors.

The spread of germs from the hands of food workers to food is an important cause of foodborne illness outbreaks in restaurants. It accounts for 89 percent of outbreaks in which food was contaminated by food workers, reported the CDC on June 18, 2019.

The Environmental Health Services suggest restaurant management and food safety programs should implement he follow prevention tactics:

Review restaurants’ practices and highlight potential barriers to and supporters of hand hygiene.
Know that efforts to improve hand hygiene in restaurants should address the factors that affect hand hygiene behavior.
Revise food-preparation activities to lower the number of needed handwashings.

There are 3 HAV vaccines approved in the USA: Vaqta, Havrix, and Twinrix, which are available at pharmacies in most states.

Furthermore, immune globulin can provide short-term protection against hepatitis A, both pre- and post-exposure.

Recent hepatitis A vaccine news

“Getting the Hepatitis A vaccine is the best way to prevent the infection; not only protecting you but also your loved ones,” says Anh Le, PharmD candidate, an intern for Brookshires Grocery Company.

“The CDC recommends the vaccine for everyone from 1 year of age and older, and it is available at pharmacies and doctor offices, so stop by for more information and stay healthy,” Le said.

Sub Title:

Hepatitis A virus concerned restaurant patrons should look for signs validating health standards have been met

References:

Hepatitis A Statewide Community Outbreak

CDC: Widespread outbreaks of hepatitis A across the United States

SUBSTANCE USE AND SUBSTANCE USE DISORDER BY INDUSTRY

CDC: Food Worker Handwashing and Restaurant Factors

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Featured:

World Hepatitis Day 2019: Invest in Hepatitis Elimination

Don Hackett — Wed, 24 Jul 2019 19:08:25 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

To celebrate World Hepatitis Day 2019, the World Health Organization (WHO) is focusing on the need for increased financing for hepatitis prevention, testing, treatment, and care services in the context of universal health coverage (UHC) with a slogan, “Invest in eliminating hepatitis”.

Launching on July 28, 2019, the World Hepatitis Day 2019 campaign says ‘Countries and partners need to work together to achieve the most optimal prices for hepatitis drugs and diagnostics to make access possible for more people.’

The World Hepatitis Day 2019 campaign intends to achieve the following objectives:

Urge national and regional policymakers increase political and financial commitments for hepatitis response,
Highlight WHO’s new cost estimates for hepatitis elimination within the context of health-related Sustainable Development Goals (SDGs) and UHC by 2030, and
Encourage more people to come forward to access hepatitis prevention, testing and treatment services

The Top 10 World Hepatitis Day message points are as follows:

Investing in hepatitis is a smart decision for broader health outcomes. Investments in hepatitis elimination would lead to a 1.5% increase in the global health price tag, but such investments would bring greater returns on better general health outcomes. Funding hepatitis testing and treatment services as part of UHC efforts can cut global deaths by 5% and increase healthy life years by about 10% by 2030.
Viral hepatitis B and C affect 325 million people worldwide, leading to about 1.4 million deaths a year. It is the second major killer infectious disease after tuberculosis, and 9 times more people are infected with hepatitis than HIV.
Hepatitis can be prevented, diagnosed, treated and managed well. The hepatitis B vaccine is 98-100% effective in preventing new infections. For hepatitis B, people should be tested and if found positive and eligible, provided with lifelong treatment. For hepatitis C, people can be cured with a simple 2-3 month treatment with direct-acting antiviral (DAA) drugs.
Over 80 percent of people living with hepatitis lack access to testing or treatment. Among people living with hepatitis B, only 10% (27 million) knew their infection status in 2016. Of these diagnosed people, only 17% (4.5 million) received treatment. Among people living with hepatitis C, 19% (13.1 million) knew their infection status in 2017, of which 15% (2 million) received cure in that same year. Overall, between 2014 and 2017, 5 million people have received a hepatitis C cure worldwide.
At the same time, people are becoming newly infected due to a lack of prevention services. In 2017, 1.1 million people were newly infected and developed chronic hepatitis B infection and 1.75 million people developed chronic hepatitis C infection. Together, hepatitis B and C account for the highest number of new infections from among other major infectious diseases such as HIV and tuberculosis.
Achieving hepatitis elimination by 2030 will require a major increase in funding for hepatitis prevention, testing and treatment services as part of achieving universal health coverage (UHC). A new WHO costing analysis underlines that additional funding of US $6 billion per year will be needed in low- and middle-income countries (LMIC) between 2016 and 2030, in order to achieve hepatitis elimination targets.
As of April 2019, 124 countries have developed or were developing, national hepatitis plans and strategies. But many of these plans lack funding. In 2017, only 58% of the 82 reported LMIC had included domestic funding in their national hepatitis plans.
The WHO’s new analysis shows that hepatitis testing and treatment are high-impact interventions that can help countries accelerate progress towards UHC. But prices for medicines and tests are very uneven and they can be very expensive in some countries. For example, hepatitis C medicines can cost as high as US$120 000 in some high-income countries. But in Pakistan, the same curative treatment can be obtained at US $15.
Investing in hepatitis testing and treatment means preventing liver cancer. Chronic infections of hepatitis B and C viruses may not show symptoms for a long period, sometimes years or decades. They slowly and silently damage the liver, eventually causing cancer. Over 60% of liver cancer cases are due to late testing and treatment of viral hepatitis B and C infections. Two-thirds of these cancer cases are caused by hepatitis B, and one third by hepatitis C.
On World Hepatitis Day 2019, help stop the neglect of viral hepatitis – share information about it. Educate yourself and others to learn risks for viral hepatitis, and access testing services. If you have been diagnosed with hepatitis B or C, speak with health workers about potential treatment, monitoring or curative therapy. If detected early, the risk of chronic illnesses and financial burden for you and your family can be averted. Take action today.

World Hepatitis Day recognizes the birthday of Dr. Baruch Blumberg (1925-2011). Dr. Blumberg discovered the hepatitis B virus in 1967 and two years later developed the first hepatitis B vaccine. For these achievements, he won the Nobel Prize in 1976.

Since March 2017, CDC’s Division of Viral Hepatitis has been assisting multiple state and local health departments with hepatitis A outbreaks, spread through person-to-person contact.

As of July 19, 2019, over 22,200 hepatitis A cases had been confirmed during this outbreak, reported the CDC.

As a regional example, the Cincinnati, Ohio area has become a leading hepatitis A hot-spot, reporting 1,060 cases as of July 15, 2019.

Unfortunately, Ohio is not the only heartland state reporting hepatitis A cases during the 2016-2019 outbreak. Kentucky has reported (4,766), West Virginia (2,528), Tennessee (1,983), and Indiana (1,744) hepatitis A cases.

Additionally, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted on June 27, 2019, to recommend all children and adolescents aged 2 through 18 years who have not previously received the hepatitis A vaccine be vaccinated.

Furthermore, the ACIP unanimously recommended updating the language concerning the utilization of hepatitis A vaccine in the Vaccines-for-Children program.

“Hepatitis isn’t a disease we hear about often, but it’s still prevalent despite being preventable. Hepatitis B and now hepatitis A vaccinations are recommended for children, but adults that did not receive the vaccines in childhood may still be at risk,” said Holly Hawbaker, Pharm D Candidate, Intern for Brookshires Grocery Company.

“Patients should talk to their doctor or pharmacist to determine if they’re at risk for hepatitis, and if they are, they can receive the appropriate hepatitis vaccine or discuss ways to reduce their risk of getting hepatitis C, which currently does not have a vaccine.”

The US Centers for Disease Control and Prevention (CDC) said on July 22, 2019, to ‘take action today’ by sharing this 5-minute online assessment which offers a personalized report on hepatitis testing and vaccination recommendations.

Sub Title:

Hepatitis A and B vaccines available at pharmacies in the USA

References:

More Information - World Hepatitis Day 2019: "Invest in eliminating hepatitis"

World Hepatitis Day Resources

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Featured:

Minors Gaining Vaccination Authority

Don Hackett — Tue, 23 Jul 2019 17:46:56 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The United States has been experiencing an increasing number of infectious disease outbreaks, such as measles and human papillomavirus (HPV) in 2019.

While most healthcare providers would agree that vaccines are one of modern civilization's greatest achievements, American parents’ resistance to vaccination is leaving more children vulnerable to vaccine-preventable illnesses.

A recent editorial published in The New England Journal of Medicine on July 11, 2019, said ‘some of these children have begun to seek opportunities to revisit vaccine-refusal decisions made on their behalf by their parents and are now pursuing vaccination options against preventable cancers and measles.

In a March 2019 congressional hearing on preventable disease outbreaks, Ohio high school senior Ethan Lindenberger shared his experience of trying to get vaccinated over his mother’s objections.

Mr. Lindenberger testified that his mother is an antivaccine advocate who believes that vaccines can cause autism and brain damage, “despite the fact such opinions have been debunked numerous times by the scientific community.”

Once he turned 18, Lindenberger went to a public health clinic for vaccinations against hepatitis A and B, influenza, and HPV.

Such cases raise the question of whether adolescent minors should be able to consent to vaccinations without parental permission.

For minors to be able to choose to be vaccinated over parental objections, most states would need to make substantive changes to laws governing medical consent. Since children are generally considered nonautonomous under U.S. law, treatment of a child in a medical setting requires parental permission, typically until a child reaches 18 years of age.

Parents are generally given broad discretion in making decisions on behalf of their children, in part because they know their child best, are positioned to weigh competing family interests and are permitted to raise their child as they choose.

Such discretion doesn’t mean that adolescents have no role in decisions that affect them.

However, out of respect for adolescents’ developing autonomy, clinicians routinely explore their understanding of health-related issues, solicit their agreement on care plans, navigate discordance between parental and adolescent preferences, and protect adolescents’ confidentiality interests.

Both ethical principles and state laws also support independent decision making by adolescents in cases in which failing to grant adolescents autonomy could foreseeably result in a substantial risk to the minor or to public health.

Anti-vaxx news

Granting minors decision-making authority for vaccination also triggers reconsideration of the materials and associated communication needed to ensure that they can make informed decisions.

Federal law requires that clinicians provide adult patients and children’s parents or legal representatives with a Vaccine Information Sheet before vaccination.

Since such materials are written at a 10th-grade reading level, they would most likely require revision if intended recipients were to include adolescents as young as 12 or 14 years of age.

Parental involvement in vaccination decisions remains important. Yet adolescents need not be harmed by parental decisions that are based on misinformation or disinformation.

Allowing adolescents to consent to vaccination despite persistent parental resistance facilitates access to a medically recommended and evidence-based treatment.

It promotes the minor’s health, poses a minimal personal risk, and offers substantial prosocial benefits, including reinforcement of the norm of vaccination and enhancement of community protection against the spread of dangerous and costly yet preventable diseases.

Given such benefits, we believe that states should enact laws that expand both access to vaccines and the rights of minors who are at least 12 to 14 years of age to consent to vaccination.

Authors included Ross D. Silverman, J.D., M.P.H., Douglas J. Opel, M.D., M.P.H., and Saad B. Omer, M.B., B.S., M.P.H., Ph.D.

Sub Title:

Herd immunity is reduced by discretionary vaccination policies

References:

Vaccination over Parental Objection — Should Adolescents Be Allowed to Consent to Receiving Vaccines?

Legal approaches to promoting parental compliance with childhood immunization recommendations

Current landscape of nonmedical vaccination exemptions in the United States: impact of policy changes

Vaccination Mandates: The Public Health Imperative and Individual Rights

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Hepatitis B Vaccine Delivered By Nanotechnology

Don Hackett — Fri, 12 Jul 2019 13:40:03 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

Kelley Lu, PharmD

Researchers have demonstrated in a new study exactly how a nanotechnology-based compound delivers an oral vaccine against hepatitis B to the immune system.

This is important news since approximately 257 million people currently live with hepatitis, says the World Health Organization (WHO).

When particles containing silica and an antigen combine, even though they are different sizes, they reach the intestine without being destroyed by the acidity of the digestive system.

A compound of nanostructured SBA-15 silica and HBsAg, the hepatitis B surface antigen, was submitted to different types of X-ray imaging. The nanostructured silica was developed by researchers at the University of São Paulo's Physics Institute (IF-USP) in Brazil. The antigen was created by the Butantan Institute, which is also in São Paulo.mm

The aim of the study was to understand how 22 nanometers-sized antigen binds to silica nanotubes with a diameter of approximately 10 nanometers and a honeycomb-like structure.

For comparison, a nanometer (1 nm) is a billionth the size of a meter.

Studies carried out at USP revealed the measurements of both the antigen and the silica nanotubes using small-angle X-ray scattering (SAXS), dynamic light scattering (DLS), and transmission electron microscope.

The three-dimensional images obtained by these techniques showed that although the antigen did not enter the nanotubes, it was retained in 50 nm macropores between the nanotubes. This protected it from the acidity of the digestive system.

The images also enabled the researchers to determine the ideal proportion of silica and HBsAg so that the antigen did not agglomerate, hindering the dispersion of the active principle in the patient's intestine.

"The oral and intranasal routes are natural modes of vaccine administration. Nature is the best vaccination agent.”

“However, a vaccine that contains a protein, as in this case, is destroyed by high acidity and its own proteases in passing through the stomach, so it doesn't reach the immune system, particularly the small intestine," said Osvaldo Augusto Sant'Anna, Scientific Leader at Butantan Institute and responsible for development of the HbsAg antigen.

Before proceeding to human clinical trials, the research team will test polymers that can be used to coat the entire structure and increase the medication's resistance to the human stomach.

In animal trials, the formulation proved to be as effective as the injected vaccine, if not more so, in delivering the antigen to the intestine, where the immune system can detect it and produce antibodies against the virus.

Through a project supported by FAPESP, the group led by Sant'Anna, Fantini and Bordalo is now developing new antigens to add to the compound. The idea is to have at least a triple vaccine by adding other antigens against diphtheria and tetanus.

However, the formulation may evolve to become a polyvaccine that also immunizes people against whooping cough, poliomyelitis and Haemophilus influenzae type B (Hib), the bacterium that causes meningitis and pneumonia, among other diseases.

The antigens must combat the diseases without interfering with each other.

"There have been very interesting results with diphtheria, and we're now going to test it for tetanus, initially in injectable form," Sant'Anna said in a press release.

The results are published in Scientific Reports.

The study was supported by São Paulo Research Foundation - FAPESP and European research funders. FAPESP is a public institution with the mission of supporting scientific research in all fields of knowledge by awarding scholarships, fellowships, and grants to investigators linked with higher education and research institutions in the State of São Paulo, Brazil.

Sub Title:

Nanotechnology may produce a polyvaccine against six diseases

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3D visualisation of hepatitis B vaccine in the oral delivery vehicle SBA-15

Nanotechnology delivers hepatitis B vaccine

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