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Gritstone bio, Inc. today announced that it was awarded a contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to conduct a Phase 2b comparative study evaluating Gritstone's self-amplifying mRNA (samRNA) CORAL vaccine candidate containing Spike plus other viral targets to protect against COVID-19.

Gritstone's approach seeks to generate a therapeutic immune response by leveraging insights into the immune system's ability to recognize and destroy diseased cells by targeting select antigens. 

The agreement, valued at up to $433 million, was awarded as part of 'Project NextGen,' an initiative by the U.S. Department of Health and Human Services (HHS).

Under the HHS contract, Gritstone will conduct a 10,000-participant, randomized Phase 2b double-blinded study in the United States in collaboration with the COVID-19 Prevention Network.

Andrew Allen, M.D., Ph.D., Co-founder, President, and Chief Executive Officer of Gritstone bio, commented in a press release on September 27, 2023, "First-generation COVID-19 vaccines provided great utility during the height of the pandemic but are limited in breadth and durability of clinical protection."

"CORAL was designed to address these limitations by inducing durable neutralizing antibody and T cell-based immunity against current and future SARS-CoV-2 (betacoronavirus) variants."

"We are excited about this opportunity to work alongside BARDA and look forward to initiating the Phase 2b study (CORAL-BARDA) in the first quarter of 2024."

An introduction video is posted at this Gritstone About Us link.

This project has been funded with Federal funds from the Department of HHS, Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50123C00062.

In August 2023, HHS awarded more than $1.4 billion for Project NextGen through the Administration for Strategic Preparedness and Response.

Vaccine Treats: 
COVID-19
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Gritstone bio Inc.
Live Blog Update Author: 
Don Hackett
Location Tags: 
Emeryville
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Recent testing has confirmed a case of plague associated with the death of an Archuleta County resident.

The Colorado Department of Public Health and Environment and San Juan Basin Public Health (SJBPH) announced on September 25, 2023, that they are investigating this plague case. 

Most human cases are acquired directly from fleas, and pets with plague can transmit the illness to humans. Over 80% of United States plague cases have been the bubonic form, according to the Centers for Disease Control and Prevention (CDC).

Plague (Yersinia pestis) is caused by bacteria that can be transmitted to humans by the bites of infected fleas or by direct contact with infected animals. Symptoms include the sudden onset of high fever and/or swollen lymph nodes, according to SJBPH.

Tiffany Switzer, Interim Executive Director of SJBPH, commented in a press release, "Plague is frequently detected in rock squirrels, prairie dogs, wood rats, and other species of ground squirrels and chipmunks."

The Colorado previously reported a plague case in Montezuma County in June 2023.

The risk to the general public is low, says SJBPH.

Most human cases in the U.S. are reported in two regions: Northern New Mexico, northern Arizona, and southern Colorado; and California, southern Oregon, and far western Nevada.

SJBPH stresses the importance of controlling wildlife and fleas around homes.

Furthermore, see a healthcare provider if you become ill with a high fever and/or swollen lymph nodes, as plague is a treatable illness.

And contact a veterinarian if your pet becomes ill with a high fever and/or an abscess (open sore) or swollen lymph nodes.

Plague was first introduced into the United States in 1900 by rat–infested steamships that had sailed from affected areas. 

The last urban plague epidemic in the United States occurred in Los Angeles from 1924 through 1925. 

New plague vaccine candidates are developing but are not expected to be commercially available immediately.

However, researchers from Tel Aviv University and the Israel Institute for Biological Research's mRNA-based, lipid nanoparticle vaccine were effective against a lethal bacteria.

Published on March 8, 2023, a mice study demonstrated that all vaccinated animals were fully protected against the bacteria that causes the plague.

To learn more about the symptoms, treatments, and other information for plague, visit https://sjbpublichealth.org/183/Communicable-Disease. Information is also available from the Colorado Department of Public Health and Environment at https://cdphe.colorado.gov/animal-related- diseases/plague.

Vaccine Treats: 
Plague
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Image Caption: 
Colorado plague map 2021
Live Blog Update Author: 
Don Hackett
Location Tags: 
Denver
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The World Health Organization (WHO) Director-General, Dr. Tedros Adhanom Ghebreyesus, recently launched the TB Vaccine Accelerator Council to facilitate the development, licensing, and using new Tuberculosis (TB) vaccines.

The 100-year-old Bacille Calmette-Guérin (BCG) is the only licensed TB vaccine, with over ten versions available globally.

While it provides moderate efficacy in preventing severe forms of TB in infants and young children, it does not adequately protect adolescents and adults, who account for the majority (>90%) of TB transmission globally, said the WHO on September 22, 2023.

In a press release, Dr. Tedros Adhanom Ghebreyesus commented, "Today, we have knowledge and tools they could only have dreamed of."

"The political declaration countries approved today, and the targets they have set, are a commitment to use those tools, and develop new ones, to write the final chapter in the story of TB."

The Council aims to identify innovative sustainable financing, market solutions, and partnerships across public, private, and philanthropic sectors. It will leverage various agencies to strengthen commitment and actions for novel TB vaccine development and access.

The U.S. Centers for Disease Control and Prevention (CDC) reported that TB outbreaks increased by 5% in 2022, with 60 U.S. states, the District of Columbia, and territories provisionally reporting 8,300 TB cases last year.

According to the CDC, TB is caused by Mycobacterium tuberculosis. The bacteria usually attack the lungs, but TB bacteria can attack any body part.

As a result, two TB-related conditions exist: latent TB infection and TB disease. If not treated properly, TB disease can be fatal.

In the U.S., Merck's TICE BCG vaccine has limited availability.

Vaccine Treats: 
Tuberculosis
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Image Caption: 
US CDC TB program 2023
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Geneva
Vaccine: 
Bacille Calmette-Guerin (BCG) Tuberculosis Vaccine
Dengue outbreaks 2023

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BioArctic AB and Eisai announced today that LEQEMBI® Intravenous Infusion had been approved in Japan as a treatment for slowing the progression of mild cognitive impairment and mild dementia due to Alzheimer's disease (AD).

LEQEMBI is a humanized immunoglobulin gamma 1 monoclonal antibody (mAbs) directed against aggregated soluble and insoluble forms of Aβ.

LEQEMBI is the first and only approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline by selectively binding to and eliminating the most toxic Aβ aggregates that contribute to neurotoxicity in AD.

Japan is the second country to approve LEQEMBI, following the Food and Drug Administration (FDA) approval in the U.S. in July 2023.

"The approval of LEQEMBI in Japan is another important step in the fight against Alzheimer's disease," said Gunilla Osswald, CEO of BioArctic, in a press release on September 25, 2023.

Eisai serves as the lead of LEQEMBI development and regulatory submissions globally, with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

BioArctic has the right to commercialize lecanemab in the Nordic region, and currently, Eisai and BioArctic are preparing for joint commercialization in the region.

According to the Alzheimer's Association, AD is a degenerative brain disease caused by complex brain changes following cell damage, leading to dementia.

As of September 2023, The U.S. FDA, the European Medicines Agency, and the United Kingdom's NHS have not authorized preventive AD vaccines.

Vaccine Treats: 
Alzheimer’s Disease
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Image Caption: 
by Deyson Ortiz
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Stockholm
Vaccine: 
LEQEMBI Alzheimer's Disease Treatment
0 min read

Since August 2023, the Indian state of Kerala has been experiencing its fourth Nipah virus outbreak.

Over the past two decades, the Nipah virus has spilled into humans in Bangladesh, India, Malaysia, the Philippines, and Singapore.

While no approved Nipah virus vaccines exist, several candidates are conducting clinical trials.

“The Nipah virus outbreak is a reminder of the increased risk of zoonotic diseases as the world population expands and encroaches into wild habitats. We have the technology to rapidly develop next-generation mRNA vaccines that will effectively fight against these new viruses”, commented Pascal Brandys, co-founder and CEO of Phylex BioSciences, in a press release on September 22, 2023.

“Our mRNA vaccine encoding for a highly immunogenic nanoparticle provides a flexible platform for rapid development of a new Nipah virus vaccine and will be of great value in combatting Nipah virus and other similar viruses.”

Phylex BioSciences published last year the proof-of-principle of its second-generation nanoparticle mRNA vaccine. The same technology is directly applicable to the development of a Nipah virus vaccine.

The second generation mRNA vaccine candidate encodes for a nanoparticle displaying 60 copies of the antigen-based upon the head domain of the G protein of the Nipah virus.

The anticipated advantages of the nanoparticle vaccine are superior immune response, long-term protection from cell-mediated immunity, and protection against virus dissemination in the brain.

Globally, an estimated two billion people worldwide are at risk for bat-borne Nipah virus outbreaks. The Nipah virus has a fatality rate exceeding 40%.

Vaccine Treats: 
Nipah virus
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The Jenner Institute 2023
Live Blog Update Author: 
Karen McClorey Hackett
Location Tags: 
Los Angeles
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Vaccine Clinical Trials 2023

Vaccine Clinical Trials 2023

The development process for new vaccines includes clinical research that involves people like you, says the U.S. National Institutes of Health. When you volunteer to participate in clinical research, you help doctors and researchers learn more about a disease and improve the care for millions of people in the future.

Vaccine Clinical Trial Availability

When developing a new vaccine, the candidate will conduct research studies called phase 1, phase 2, phase 3, and phase 4. Each phase of the development is essential, and all need active participants. TrialReach.com offers information about each clinical trial's purpose, who may participate, locations, and more details.

This clinical information should be used in conjunction with advice from healthcare professionals. Top doctors may see you in each category to discuss advanced treatment at no cost to you. Furthermore, financial compensation for participants varies by the type of clinical study. And you can earn compensation for your time and travel. Start your no-cost search today at this sponsored TrialReach link.

Vaccine Clinical Trials and Artificial Intelligence - Machine Learning

In 2023, the U.S. Food and Drug Administration (FDA) recognized the increased use of Artificial Intelligence (AI) and Machine Learning (ML) algorithms throughout the drug development life cycle, including vaccine clinical trials. With more than 100 submissions reported in 2021, these AI/ML submissions traverse the drug development landscape.

As part of this effort, the FDA's Center for Drug Evaluation and Research, in collaboration with the Center for Biologics Evaluation and Research and the Center for Devices and Radiological Health, issued a discussion paper to communicate the use of AI/ML in developing drugs and vaccines.

 

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Saturday, September 23, 2023 - 16:25
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Alzheimers, Herpes, HIV, dengue, Lyme disease, cancer, yellow fever, and Zika vaccine candidates are conducting clinical trials in 2023
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Herpesvirus
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A contagious disease known for causing outbreaks on land and at sea may soon have an approved preventive vaccine. Noroviruses have emerged as the single most significant cause of gastroenteritis worldwide. 

According to the U.S. Centers for Disease Control and Prevention, most norovirus outbreaks in the United States happen from November to April. In years when there is a new strain of the virus, there can be 50% more norovirus illness.

While no vaccines are available today in the U.S., U.K., or Europe, a new funding event may accelerate an approval.

HilleVax, Inc. today announced the gross proceeds from an offering, before deducting discounts, commissions, and other expenses, are expected to be $100.0 million.

HilleVax stated in a press release on September 20, 2023, that it intends to use the net proceeds from the offering to fund the clinical development of HIL-214, including certain manufacturing activities, and for working capital and general corporate purposes.

HIL-214 is an investigational virus-like particle bivalent vaccine candidate for preventing moderate-to-severe acute gastroenteritis caused by norovirus in infants. 

The HIL-214 vaccine includes antigens from genotypes GI.1 and GII.4 to represent genogroups that cause most human illnesses.

HIL-214 has been studied in various clinical trials, collectively generating data from more than 4,500 subjects, including children. The ongoing phase 2/3 study was last updated in May 2023.

“HilleVax has continued to make excellent progress on our HIL-214 program, including the recent completion of enrollment of over 3,000 subjects in our NEST-IN1 clinical trial,” said Rob Hershberg, MD, PhD, Chairman and Chief Executive Officer of HilleVax, in a press release on May 12, 2023.

“We look forward to continuing to execute on our HIL-214 program and announcing top-line safety and clinical efficacy data in the first quarter of 2024 for our NEST-IN1 clinical trial.”

While other norovirus vaccine candidates are conducting clinical research, the HIL-214 vaccine appears to Precision Vaccinations to be the most advanced candidate.

Vaccine Treats: 
Norovirus
Image: 
Image Caption: 
US CDC norovirus case map September 2023
Live Blog Update Author: 
Don Hackett
Location Tags: 
Boston
Vaccine: 
HIL-214 Norovirus Vaccine