Lassa Fever

Preventive vaccination could be a key strategy against Lassa fever

Since the disease was first documented in 1969, Lassa fever has become a public health risk in western Africa.

For the first time, researchers at the University of Liverpool and the University of Oxford have estimated the current burden of Lassa fever, projected the impacts of a Lassa fever vaccination program, and demonstrated how it may help avoid a future pandemic.

The World Health Organization (WHO) has expressed concerns that a Lassa-related virus could cause a global concern due to the lack of effective vaccines and treatments.

Published on August 28, 2024, this study estimates the health-economic burden of Lassa fever throughout West Africa and projects the impacts of a series of vaccination campaigns.

It suggests how vaccination could alleviate the burden and assist in pandemic preparedness.

These London-based researchers also model the emergence of ‘Lassa-X’—a hypothetical pandemic Lassa virus variant—and project impacts of achieving 100 Days Mission vaccination targets.

Their model predicted 2.7 million (95% uncertainty interval: 2.1–3.4 million) Lassa virus infections annually, resulting in 2.0 million (793,800–3.9 million) disability-adjusted life years (DALYs) over ten years.

A population-wide preventive campaign targeting WHO-classified ‘endemic’ districts was found to be the most effective vaccination strategy.

Under conservative vaccine efficacy assumptions, this campaign averted $20.1 million ($8.2–$39.0 million) in lost DALY value and $128.2 million ($67.2–$231.9 million) in societal costs.

Reactive vaccination in response to local outbreaks averted just one-tenth the health-economic burden of preventive campaigns.

In the event of Lassa-X emerging, spreading throughout West Africa, and causing approximately 1.2 million DALYs within two years, 100 Days Mission vaccination averted 22% of DALYs given a vaccine 70% effective against the disease, and 74% of DALYs given a vaccine 70% effective against both infection and disease.

As of late August 2024, several Lassa fever vaccine candidates are conducting clinical research.

The Coalition for Epidemic Preparedness Interventions funded this study, which was published in the journal Nature Medicine.

Sub Title:

Lassa Fever virus preventive vaccines are essential to public health

References:

Health and economic impacts of Lassa vaccination campaigns in West Africa

US CDC Lassa Fever

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Nature Medicine - Lassa Fever case map - August 28, 2024

UTMB Boosts Protective Vaccine Development Against Hemorrhagic Fever

Don Hackett — Fri, 08 Nov 2019 22:27:19 +0000

Reviewer:

NIH: Study vaccine protects monkeys against four types of hemorrhagic fever viruses

Recent outbreaks in Africa have highlighted the need for a prophylactic vaccine that would confer protection against all of the viruses that cause lethal hemorrhagic fever (HF).

On November 8, 2019, scientists funded by the National Institutes of Health (NIH) announced the development of an investigational vaccine that protected monkeys against 4 types of HF viruses that are endemic to overlapping regions in Africa.

The University of Texas Medical Branch (UTMB) , which is located in Galveston, Texas and Profectus BioSciences are developing the vaccine candidate, quadrivalent VesiculoVax vaccine.

This is important news since there are no licensed vaccines to provide protection from any of those viruses, all of which can cause severe disease and death.

Recently, the European Medicines Agency has recommended licensing a VSV-Ebola vaccine from Merck, Ervebo, V920.

And, on November 7th, 2019, the Janssen division of Johnson & Johnson announced it had filed for two approvals from European Medicines Agency (EMA) for its 2-dose prime-boost Ebola Zaire protective vaccine regimen, known as Ad26.ZEBOV/MVA-BN-Filo.

This new study, published in the Journal of Clinical Investigation on October 23, 2019, describes how the vaccine was created using a live-attenuated vesicular stomatitis virus to deliver proteins that elicit protective immune responses.

The proteins are from the Ebola virus (Kikwit strain), Sudan virus (Boniface strain, which also causes Ebola virus disease), Marburg virus (Angola strain) and Lassa virus (Josiah strain).

Importantly, the monkeys infected in the study were exposed to different strains of Sudan virus (Gulu) and Lassa virus (0043/LV/14) than those in the candidate vaccine to help the researchers determine whether the vaccine would be cross-protective.

Lassa 0043/LV/14 is circulating in an outbreak in Nigeria that began in 2018.

And, previous studies indicate that the investigational Ebola virus (Kikwit) vaccine will protect against other strains of the Ebola virus.

These innovative scientists inoculated 20 monkeys with a primary and booster dose of quadrivalent VesiculoVax.

The animals had 5 blood draws to check for an immune response, including on the day of initial vaccination and on days 10 and 28, then on day 56 when they received a booster inoculation, and again on day 66.

On day 84, the scientists infected the macaques with the 4 different hemorrhagic fever viruses and monitored them until day 112 of the study.

Twelve additional macaques in the study who were infected with the viruses but not vaccinated all became sick.

However, none of the vaccinated animals did.

Only one of the 20 vaccinated animals had any of the four hemorrhagic fever viruses detectible (Lassa) following the study.

The scientists state that the addition of the Lassa virus component to their multivalent vaccine is an exciting research advance as they already had developed an investigational trivalent vaccine that provided protection against Ebola, Sudan, and Marburg viruses.

These researchers now plan further vaccine tests against other strains of the Lassa virus, and they want to further evaluate whether a single-dose quadrivalent vaccine appears safe and effective.

UTMB Health offers a full range of primary and specialty health care services throughout Galveston and Brazoria counties, the Bay Area and Southeast Texas. With approximately 70 primary and specialty care clinics, dozens of locations, and 3 large modern campuses featuring comprehensive hospital and emergency care, UTMB is a health system that continues to enhance access to excellent care.

This research was supported by NIH/NIAID intramural funding, contract HHSN272201700077C, and grants UC7AI094660 and U19AI142785; and by NIH/NHGRI grants U01HG007480 and U54HG007480.

Vaccine Research is published by Precision Vaccinations

Sub Title:

Quadrivalent Vesiculovax vaccine found protective from viral-induced hemorrhagic fever

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Quadrivalent Vesiculovax vaccine protects nonhuman primates from viral-induced hemorrhagic fever and death

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Lassa Fever Vaccine Candidate Launched Phase 1 Study

Don Hackett — Tue, 29 Oct 2019 20:06:56 +0000

Reviewer:

Themis Bioscience and CEPI Announce Initiation of Phase 1 Clinical Trial with Lassa Fever Vaccine

Austria and Norway researchers announced the 1st administration to study volunteers of a vaccine candidate against Lassa fever.

The MV-LASV Lassa fever vaccine candidate is based on Themis Bioscience’s proprietary measles vector platform and exclusively-licensed discoveries made at Institut Pasteur.

This is important news since there is currently no vaccine that protects people against Lassa fever.

The phase 1 clinical trial for the MV-LASV Lassa fever vaccine program is funded through a global partnership with Coalition for Epidemic Preparedness Innovations (CEPI) that will support the vaccine’s development up to the end of Phase 2, which is designed to provide clinical safety and immunogenicity of MV-LASV after administration of 2 different dose levels.

The MV-LASV vaccine candidate is a recombinant, live-attenuated, viral vectored vaccine, based on the backbone of the measles Schwarz virus strain for prophylaxis of Lassa infection.

Dr. Melanie Saville, Director of Vaccine Development at CEPI added in a press release, “This first-in-human trial for Themis’ MV-LASV Lassa candidate is an important first step in its evaluation in the clinic and toward developing an effective vaccine which will be available to at-risk populations during outbreaks of this deadly emerging infectious disease.”

The study, sponsored and led by Themis, is being conducted by the Centre for the Evaluation of Vaccination in Antwerp, Belgium, under the direction of Pierre Van Damme, MD, Ph.D., Professor at the University of Antwerp, Faculty of Medicine and Health Sciences.

Recent Lassa virus vaccine news

Lassa fever, also known as Lassa hemorrhagic fever, is an acute viral disease that occurs mostly in West Africa, says the Centers for Disease Control and Prevention (CDC).

Lassa virus infection in West Africa is estimated to affect 300,000 people annually, resulting in approximately 5,000 fatalities.

The virus can spread from person-to-person via bodily fluids and causes a range of symptoms including vomiting, swelling of the face, bleeding, and pain in the chest, back, and abdomen, said the company.

CEPI is an innovative partnership between public, private, philanthropic, and civil organizations launched in Davos in 2017 to develop vaccines to stop future epidemics. CEPI has reached over US$750 million of its $1 billion funding target. Learn more at CEPI.

Themis is developing immunomodulation therapies for infectious diseases and cancer through an advanced understanding of immune system mechanisms. For more information, visit ThemisBio.

Lassa Virus vaccine news published by Precision Vaccinations

Sub Title:

MV-LASV vaccine candidate is based on the backbone of the measles Schwarz virus strain for prophylaxis of Lassa infection

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A Trial to Evaluate the Optimal Dose of MV-LASV

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Lassa Fever Vaccine Confers Full-Protection With 1-Dose

Danielle Reiter RN — Wed, 04 Sep 2019 19:16:43 +0000

Reviewer:

Holly Lutmer PharmD

A Georgia-based biotechnology company announced the publication of an article entitled “A Single Dose of Modified Vaccinia Ankara Expressing Lassa Virus-like Particles Protects Mice from Lethal Intra-cerebral Virus Challenge.”

The paper published in Pathogens on September 4, 2019, shows that a single intramuscular (IM) dose of GEO-LM01 provided 100 percent protection in mice challenged with a lethal dose of ML29 (a Mopeia/Lassa reassortant virus) delivered directly into the brain.

According to GeoVax Labs, this is the 1st report showing that a single dose of a replication-deﬁcient Modified Vaccinia Ankara (MVA) vector can confer full protection against a lethal challenge.

This is important news since Lassa fever cases surpass Ebola, Marburg, and all other hemorrhagic fevers except Dengue in public health impact.

In contrast to the unpredictable epidemics of filoviruses such as Ebola, Lassa fever is endemic in West Africa, with an annual disease incidence of over 300,000, causing up to 10,000 deaths, says the World Health Organization (WHO).

The WHO continues to advise all countries in the 'Lassa Fever Belt' of central West Africa on the need to enhance early detection and treatment of cases to reduce the case fatality rate as well as strengthen cross-border collaboration.

The GEO-LM01 Lassa fever vaccine candidate is based on GeoVax’s novel Modified Vaccinia Ankara Virus-Like Particle (VLP) platform, which generates noninfectious VLPs in the individual being vaccinated.

VLPs mimic a natural infection, triggering the body to produce a robust and durable immune response with both antibodies and T cells.

GEO-LM01 is one component of a multivalent hemorrhagic fever virus vaccine being developed by GeoVax. The other vaccine components are for protection against Sudan virus (SUDV), Marburg virus (MARV), and Ebola virus (EBOV).

Lassa fever is caused by an infection with Lassa virus, a member of the Arenaviridae virus family. The virus can cause severe hemorrhagic illnesses with up to 50 percent case fatality rates in an overlapping region with the Ebola virus.

The Lassa virus is transmitted to humans by African rats that live in large numbers in agricultural areas near human habitations.

The virus can also be transmitted from human to human through nosocomial infections.

Nosocomial infections refer to any systemic or localized conditions that result from the reaction by an infectious agent or toxin, says the WHO.

GeoVax Labs, Inc. is a clinical-stage biotechnology company developing human vaccines against infectious diseases and cancer using a novel patented Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) based vaccine platform.

Sub Title:

GeoVax Labs GEO-LM01 vaccine candidate provided 100 percent protection in mice challenged with a lethal dose of ML29 delivered into the brain

References:

GeoVax Announces Publication of Lassa Fever Vaccine Study Results

A Single Dose of Modified Vaccinia Ankara Expressing Lassa Virus-like Particles Protects Mice from Lethal Intra-cerebral Virus

Lassa Fever Vaccine Candidate To Report Significant Efficacy

WHO: Lassa Fever

CDC: Lassa Fever

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Lassa Fever Vaccine Candidate To Report Significant Efficacy

Danielle Reiter RN — Tue, 16 Jul 2019 18:41:33 +0000

Reviewer:

GeoVax Announces Upcoming Presentation of Lassa Fever Vaccine Data

A biotechnology company specializing in developing human vaccines announced in a press release an oral presentation entitled, 'A Single Dose of MVA-Based Lassa Virus Vaccine Provides Complete Protection in a Mouse Lethal Challenge Model', will be given during the Annual Meeting of the American Society for Virology, being held July 20, 2019.

In her pending talk, Senior Scientist, Mugdha Vasireddi, Ph.D., will discuss the preclinical efficacy studies of GEO-LM01, a novel vaccine candidate for Lassa fever constructed on a Modified Vaccinia Ankara (MVA) vector expressing 2 immunogens derived from the Lassa virus.

The highlight of this small, non-human study, is this is the first report that a replication-deficient MVA vector can confer full protection against Lassa after a single vaccine dose.

This research is important because there is no treatment or vaccine available to stem Lassa fever epidemics.

And, in contrast to the unpredictable epidemics of filoviruses such as Ebola, Lassa fever is endemic in West Africa, with an annual disease incidence of over 300,000, leading to 5,000 to 10,000 deaths, says the World Health Organization (WHO).

Upon vaccination, these immunogens form Virus-Like Particles (VLPs) in the host which will, in turn, induce immunity against subsequent infections with the Lassa virus.

Immunogenicity and efficacy of the GEO-LM01 vaccine were tested in a mouse challenge model.

A single intramuscular dose of GEO-LM01 protected 100% of normal mice challenged with a lethal dose of ML29, a Mopeia/Lassa reassortant virus, delivered directly into the brain.

In contrast, all control animals died within one week.

The vaccine-induced low levels of antibodies but strong CD4+ and CD8+ T cell responses.

The data being presented by Dr. Vasireddi contributed to the body of information resulting in a $300,000 Fast Track Phase I/II Small Business Innovative Research (SBIR) grant to GeoVax from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in April 2018.

As well as a $2.4 million grant awarded to GeoVax in September 2018 by the U.S. Department of Defense, in support of advanced preclinical testing of the GeoVax Lassa fever vaccine.

Lassa Fever symptoms & transmission

The Lassa virus is transmitted to humans by African rats that live in large numbers in agricultural areas near human habitations. The virus can also be transmitted from human to human through nosocomial infections.

Lassa Fever news

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GeoVax Labs Lassa Fever vaccine candidate GEO-LM01 is reporting that a replication-deficient MVA vector can confer full protection against Lassa virus after one vaccine dose

References:

WHO: Lassa Fever

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Lassa Fever DNA Vaccine Candidate Advances

Don Hackett — Fri, 24 May 2019 21:18:36 +0000

Reviewer:

Inovio First to Advance Lassa Fever Candidate Vaccine Into a Clinical Trial

A DNA candidate vaccine to prevent infection from the Lassa virus announced it has dosed subjects in a first-in-human, Lassa Fever vaccine candidate clinical trial.

This is good news since the case-fatality rate among patients hospitalized for Lassa Fever is up to 20 percent and there are no licensed vaccines or approved treatment for Lassa Fever available as of May 24, 2019.

Inovio Pharmaceuticals, Inc. plans to enroll approximately 60 volunteers in the INO-4500 study, which is a placebo-controlled, blinded, dose escalation study evaluating the safety, tolerability, and immune responses.

The INO-4500 program is fully funded through a global partnership with the Coalition for Epidemic Preparedness Innovations.

In a previously published paper, Inovio reported that its DNA candidate vaccine against Lassa fever provided 100% protection in non-human primates challenged with a lethal dose of the virus in a pre-clinical study.

Inovio's synthetic nucleic acid platform of immunotherapies and vaccines deliver optimized synthetic antigen genes into cells with CELLECTRA® immune enhancing systems, where they are translated into protein antigens that activate an individual's immune system to generate robust targeted T cell and antibody responses.

Inovio's immunotherapies function exclusively in vivo and have generated an antigen-specific immune response against targeted diseases in all clinical trials to date.

Lassa fever, also known as Lassa hemorrhagic fever, is an acute viral disease which occurs mostly in West Africa, says the Centers for Disease Control and Prevention (CDC).

Lassa virus infection in West Africa is estimated to affect 300,000 people annually, resulting in approximately 5,000 deaths, as disease and infection surveillance has been poor.

Recently, during February 2019, a Lassa Fever outbreak in Nigeria caused 72 deaths across 20 states and the Federal Capital Territory. This new data represents a case fatality ratio of 22 percent, based on 324 confirmed cases and 3 probable cases during 2019.

Recent Lassa Fever news:

Lassa Fever can cause a range of symptoms including fever, vomiting, and swelling of the face, pain in the chest, back and abdomen, bleeding of various parts of the body including the eyes and nose.

This infection is spread through contact with infected rodents. Person to person transmission is also possible, via bodily fluids, albeit less common, says the CDC.

Inovio expects to advance its Lassa candidate vaccine into a Phase 2 field trial in endemic countries of West Africa later in 2019/2020.

With satisfactory Phase 2 data, CEPI in cooperation with local regulatory authorities may stockpile the Inovio vaccine for future use throughout the region.

CEPI is an innovative partnership between public, private, philanthropic, and civic organizations launched in Davos in 2017 to develop vaccines to stop future epidemics.

CEPI has received multi-year funding from Norway, Germany, Japan, Canada, Australia, and the Bill & Melinda Gates Foundation, and Wellcome. Learn more at CEPI.net.

Inovio is an innovative biotechnology company focused on the discovery, development, and commercialization of its synthetic nucleic technology targeted against cancers and infectious diseases. For more information, visit Inovio.

Sub Title:

Inovio INO-4500 vaccine candidate is funded in part by the Coalition for Epidemic Preparedness Innovations

References:

Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers

Pre-clinical development of a vaccine against Lassa fever

Lassa Fever Outbreak Reaches 22% Fatality Ratio

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Lassa Fever Outbreak Reaches 22% Fatality Ratio

Don Hackett — Wed, 20 Feb 2019 19:50:26 +0000

Reviewer:

Nigeria: Lassa Fever Outbreak - Jan 2019

The Lassa Fever outbreak in Nigeria has now caused 72 deaths across 20 states and the Federal Capital Territory through February 10, 2019.

This new data is important since it, unfortunately, represents a case fatality ratio of 22 percent, based on 324 confirmed cases and 3 probable cases during 2019, which was published by the World Health Organization (WHO)

Of the 3,746 contacts identified in 2019, 2,658 are still under follow-up care, while 1,045 people have completed the 21 days of follow-up monitoring.

Since there is currently no approved vaccine, early supportive care with rehydration and symptomatic treatment improves an infected person’s survival, says the WHO.

Previously, on January 21, 2019, the Nigeria Centre for Disease Control (NCDC) declared a Lassa fever outbreak.

WHO continues to advise all countries in the ‘Lassa Fever Belt” of central west Africa, on the need to enhance early detection and treatment of cases to reduce the case fatality rate as well as strengthen cross-border collaboration.

The Lassa virus is transmitted to humans via contact with food or household items contaminated with rodent urine or feces. Person-to-person infections can also occur, particularly in hospitals lacking adequate infection prevention and control measures, says the WHO.

Lassa fever usually causes mild symptoms, including slight fever, weakness, and headache. However, in some people, it can cause more serious symptoms, like bleeding in the gums, eyes, or nose.

To alert Americans prior to visiting Nigeria, the US Centers for Disease Control and Prevention (CDC) issued a Level 1 Travel Alert regarding Lassa Fever on February 7, 2019.

Historically, there have been very few Lassa Fever cases reported in the USA. The CDC and the New Jersey Department of Health confirmed 1 death in a person returning to the USA from Liberia in 2015.

This ‘Practice Usual Precautions’ Alert says travelers who develop serious symptoms of Lassa fever during or after their trip should see a doctor right away. They should tell the doctor where they traveled in Nigeria and whether they had contact with a rodent or sick person.

Additionally, the CDC issued multiple Level 2, Travel Alerts, for Nigeria:

The CDC advises any visitor to Nigeria to be fully protected with an appropriate vaccine. This list of diseases and vaccines can be found at this CDC page.

International travelers can schedule pre-trip vaccine and medication counseling sessions with a local pharmacy at Vax-Before-Travel.

Additionally, the US State Department issued a Level 3 Travel Advisory on February 7, 2019, advising visitors to Nigeria 'Reconsider Travel’.

Sub Title:

Nigeria is confronting Lassa Fever, Yellow Fever, Polio and Monkeypox virus outbreaks during 2019

References:

Lassa Fever – Nigeria

Lassa Fever in Nigeria

Health Information for Travelers to Nigeria Traveler View

Nigeria Travel Advisory

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Lassa Fever Vaccine Candidate Passes Animal Test

Don Hackett — Sun, 14 Oct 2018 15:33:05 +0000

Reviewer:

Non-neutralizing antibodies elicited by recombinant Lassa–Rabies vaccine are critical for protection against Lassa fever

Combining 2 vaccines may be the solution to preventing the spread of Lassa fever, reported Thomas Jefferson University in a press release.

This is good news since there is not a commercially available Lassa fever vaccine, and this virus infects over 100,000 people and kills 5,000 per year.

The combination of rabies and Lassa vaccines produced protection in animal models, according to research published in the journal Nature Communications.

This inactivated recombinant vaccine candidate uses a weakened rabies virus vector.

The research team inserted genetic material from the Lassa virus into the rabies virus vector so the vaccine expresses surface proteins from both the Lassa virus and the rabies virus.

These surface proteins prompt an immune response against both Lassa and rabies viruses.

The recombinant vaccine was then inactivated to “kill” the live rabies virus used to make the carrier.

Because this vaccine candidate is inactivated and based on a rabies vaccine, the safety profile of the combination vaccine is excellent and likely safe enough to administer to pregnant women, who have a high risk of miscarriage when infected with Lassa virus, said these researchers.

In addition, this pre-human vaccine could likely produce a stable lyophilized format that is easy to use in clinics that lack refrigeration.

The research also points to a new way to test for protection against the virus that causes Lassa fever, a finding that could significantly speed up human vaccine development.

“This two-component vaccine showed good protection from exposure to both virus types in preliminary animal studies,” said senior author Matthias Schnell, Ph.D., Chair of the Department of Microbiology and Immunology at Thomas Jefferson Universiy and Director of the Jefferson Vaccine Center.

“Perhaps more importantly, however, we’ve discovered how to test for protection, which could vastly improve our ability to translate these findings into a human-ready vaccine,” said Dr. Schnell.

This study’s results could have implications for other hemorrhagic fever viruses as well.

Dr. Schnell, together with colleagues from the National Institutes of Allergy and Infectious Disease (NIAID) and University of California, San Diego (UCSD), looked at antibodies against other parts of the Lassa virus glycoprotein.

Although these antibodies can’t block the infection, the researchers showed that in the case of Lassa, they can be quite effective at tagging the virus or virus-infected cell with a beacon for quicker identification by other immune defense cells, such as the natural killer immune cell.

The researchers used this concept to develop a new test to quantify the number of cells killed by antibody tagging/NK cell attack, creating a new surrogate of protection against Lassa virus hemorrhagic disease, based on flow cytometry.

They also showed that a certain class of IgG against Lassa virus is beneficial.

Lassa fever is an acute viral hemorrhagic illness that occurs in West Africa, say the World Health Organization (WHO).

The Lassa virus is transmitted to humans via contact with food or household items contaminated with rodent urine or feces. Person-to-person infections and laboratory transmission can also occur, particularly in hospitals lacking adequate infection prevention and control measures.

The observed case-fatality rate among patients hospitalized with severe cases of Lassa fever is 15 percent, says the WHO.

These researchers are also exploring other approaches to help determine vaccine protection in the field.

This work was supported in part by NIH grants R01 AI105204, by the Jefferson Vaccine Center and by the Portuguese Foundation for Science and Technology fellowship PD/BD/105847/2014. This work was also funded in part through the NIAID Division of Intramural Research and the NIAID Division of Clinical Research, Battelle Memorial Institute’s prime contract with the US National Institute of Allergy and Infectious Diseases (NIAID) under Contract No. HHSN272200700016I and an NIH grant in aid (AI110700). Tiago Abreu-Mota, Peter B. Jahrling, and Matthias J. Schnell are inventors on the U.S. Provisional Patent Application No. 62/691,413.

All other authors declare no competing interests.

Sub Title:

Jefferson Vaccine Center combined rabies and Lassa fever vaccines to produce protection in animal models

References:

Lassa Fever

Scientists develop novel vaccine for Lassa fever and rabies

Lassa Fever Vaccine Shows Promise and Reveals New Test for Immunity

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Tropical Disease Priority List Expanded by FDA

Don Hackett — Thu, 23 Aug 2018 15:05:45 +0000

Reviewer:

FDA In Brief: FDA adds four tropical diseases to priority review voucher program to encourage drug development in areas of unmet

The U.S. Food and Drug Administration (FDA) announced the addition of Lassa fever, chikungunya virus disease, rabies and cryptococcal meningitis to its list of tropical diseases.

“Today we’ve added four diseases to a program designed to encourage the development of new drug and biological products to prevent or treat certain tropical diseases affecting millions of people throughout the world,” said FDA’s Chief Scientist RADM Denise Hinton, in a press release.

The diseases added today by the FDA are:

Lassa fever
Chikungunya virus disease
Rabies
Cryptococcal meningitis

“Tropical diseases cause a significant health burden globally. Yet, there has been remarkably little progress over the past 50 years in drug and biologic development to treat and prevent these diseases,” said Hinton.

“Although tropical diseases generally are uncommon in the United States, tourism, immigration, and military operations are increasing the direct effect these diseases can have on the health of Americans.”

According to a recent study, over the past decades, Gulf Coast storms may have empowered the spreading of neglected tropical diseases (NTDs), such as West Nile, Chagas, Chikungunya, Typhus and Dengue viruses to thrive, said Dr. Peter Jay Hotez, from the Baylor College of Medicine, author of Vaccines Did Not Cause Rachel's Autism: My Journey as a Vaccine Scientist, Pediatrician, and Autism Dad.

NTDs impair physical and cognitive development, and can contribute to mother and child illnesses and death, says the Centers for Disease Control and Prevention (CDC).

Further analysis by Dr. Hotez reveals that up to 4 million of the 60 million people living in 5 Gulf Coast states; Texas, Louisiana, Mississippi, Alabama, and Florida, are affected by at least 1 NTD.

Also, there are concerns about the possible return of West Nile virus to the USA.

Since the summer of 1999, West Nile virus has quietly spread to most states in the USA. More than 46,068 West Nile virus (WNV) cases and 2,018 deaths have been reported through 2016.

As of July 24, 2018, a total of 45 states have reported 231 West Nile cases in people to the Centers for Disease Control and Prevention (CDC).

Of these WNV cases, 62 (58%) were classified as neuroinvasive diseases, such as meningitis or encephalitis.

These tropical diseases will be added to the current list, which includes:

Tuberculosis
Malaria
Blinding trachoma
Buruli ulcer
Cholera
Dengue/Dengue hemorrhagic fever
Dracunculiasis (guinea-worm disease)
Fascioliasis
Human African trypanosomiasis
Leishmaniasis
Leprosy
Lymphatic filariasis
Onchocerciasis
Schistosomiasis
Soil-transmitted helminthiasis
Yaws
Filovirus Diseases
Zika Virus Disease
Chagas disease (August 20, 2015, final order)
Neurocysticercosis (August 20, 2015, final order)

With the tropical disease priority review voucher program, Congress intended to stimulate the development of drugs and biologics to prevent and treat infectious diseases for which there are no significant markets in developed nations and that disproportionately affect poor and marginalized populations.

Applicants who submit applications for drug or biological products to prevent or treat these diseases may qualify for a tropical disease priority review voucher.

For additional information regarding this FDA program, please visit this site.

Sub Title:

Lassa fever, chikungunya virus, rabies and cryptococcal meningitis added to FDA tropical disease priority review voucher program

References:

Tropical Disease Priority Review Voucher Program

Will Alberta Bring Infectious Disease Back to the Third-Coast?

West Nile Virus in the USA - Dallas Reports 3rd Human Case

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Liberia Reports Significant Infectious Disease Outbreaks

Don Hackett — Tue, 19 Jun 2018 18:08:44 +0000

Reviewer:

Liberia IDSR Epidemiology Bulletin

The country of Liberia reported disturbing infectious disease news on June 10, 2018.

According to the Integrated Disease Surveillance and Response Bulletin #23, there were a total of 132 suspected cases of reportable infectious diseases and events, including 24 deaths, in just one week.

This new information indicates Liberia, which is located on the west coast of Africa, may be losing its infectious disease battle.

This disturbing information may motivate the US Centers for Disease Control and Prevention (CDC) to reevaluate its 2015 decision to remove Liberia from a Level 3 Travel Alert status.

As of June 8, 2018, the CDC does not list Liberia on its health alert index. The CDC did update its vaccination and disease advice for international travelers to Liberia on March 12, 2018.

During 2017, Liberia recorded 4,729 suspected cases for 10 immediately reportable diseases and events in 2017. This data reflects a negative trend when compared to 3,812 reported cases in 2016.

Specifically, the Liberia June 10, 2018 report detailed the following disease occurrences:

Acute Flaccid Paralysis: Four cases were reported. Cumulatively, since Epi week one, 31 cases have been reported and 26 tested negative with 5 pending.
Lassa Fever: Nine suspected Lassa fever cases were reported. Cumulatively, since Epi week one, 116 suspected cases have been reported including 33 deaths.
Measles: Sixty-one (61) suspected cases of measles were reported. Cumulatively, since Epi-week one, 2,979 suspected measles cases have been reported.
Meningitis: One suspected case of meningitis was reported. Cumulatively, since Epi-week one, 36 suspected cases have been reported of which fifteen have been tested; two were positive by RT-PCR for Neisseria meningitides serotype w and thirteen negatives.
Tetanus: One suspected case of Neonatal tetanus was reported. Cumulatively, since Epi-week one, 5 clinically diagnosed cases have been reported.
Yellow Fever: Two cases of Yellow fever were reported. Cumulatively, since Epi-week one, 48 suspected cases have been reported and 44 tested negative, two pending.

This extensive list is best reviewed with a certified travel vaccine pharmacy 10 or more days prior to traveling to Liberia.

International travelers can request a vaccine appointment with a pharmacy.

** Schedule Vaccine Appointments Here **

The CDC Vaccine Price List provides the private sector vaccine prices for general information, and vaccine discounts can be found here.

Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to the FDA or CDC.

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Lassa fever, acute flaccid paralysis, tetanus, measles, meningitis and yellow fever outbreaks reported in Liberia

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Health Information for Travelers to Liberia Clinician View

Weekly Bulletin

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Rapid Plug & Play Vaccine Development Platform Announced

Don Hackett — Mon, 11 Jun 2018 16:45:56 +0000

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Development of vaccines from AIDS to Zika, using a novel 'plug and play' viral platform

Researchers have developed a flexible "Plug and Play" technology platform that delivers single-dose vaccines that fully protect against emerging infectious diseases, such as Zika, Lassa fever, and Ebola.

"A significant unmet medical need exists for vaccine platform technologies to respond rapidly and effectively against biological threats," said Rahul Basu, a scientist at GeoVax and lead author on the study.

"Preferably, such platforms should deliver vaccines that are safe and confer full protection after a single dose,” said Basu in a press release.

In proof-of-concept studies, the researchers tested three independent vaccines against three different families of viruses.

Each vaccine demonstrated full protection after a single dose, using various lethal challenge models:

For the Zika vaccine, a single inoculation of MVA-Zika vaccine in normal (immunocompetent) mice provided 100% protection against a lethal challenge dose of a neurovirulent ZIKV delivered directly into the brain.
A single inoculation of MVA-VLP-Ebola vaccine candidate provided full protection in a rhesus monkey lethal challenge model.
A single inoculation of MVA-VLP-LASV vaccine protected mice against a lethal challenge delivered directly into the brain.

"To demonstrate a broad utility of the platform, we developed prophylactic and therapeutic vaccines for other infectious diseases as well as cancer," said Mr. Basu.

These included prophylactic and therapeutic vaccines for HIV (already in advanced clinical trials), preventive vaccines for Marburg, Sudan and Malaria, all with major epidemic potential with high human lethality, as well as therapeutic vaccines for chronic hepatitis B infections and tumor-associated antigen (TAA)-based-cancer vaccines.

These studies on single-dose vaccines for emerging infectious diseases were supported with funding from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and performed at laboratories of the Centers for Disease Control, (CDC) in Fort Collins, CO, Institute of Human Virology, University of MD and NIH's Rocky Mountain Laboratories have demonstrated the broad utility of the platform.

This new research was presented at the annual meeting of the American Society for Microbiology, held from June 7, 2018.

The American Society for Microbiology is the largest single life science society, composed of more than 30,000 scientists and health professionals. ASM's mission is to promote and advance the microbial sciences.

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GeoVax vaccine platform approach suited for use against biological threats and amenable to rapid, large-scale production

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DNA Vaccines Against Lassa Fever and MERS Receive Phase 2 Funding

Don Hackett — Fri, 13 Apr 2018 16:47:37 +0000

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