Intranasal COVID-19 vaccine headed to clinical trials

The trial will compare efficacy, safety of new vaccine against FDA-approved mRNA shot

2024-06-14

(Press-News.org) University of Georgia-based startup CyanVac LLC received federal funding to support a comparative Phase 2b clinical trial of CVXGA, the company’s intranasal vaccine candidates designed to protect against COVID-19.

As part of the award from Project NextGen, a federal initiative based in the U.S. Department of Health and Human Services (HHS), CyanVac will sponsor a randomized, double-blind Phase 2b study with 10,000 participants to compare the efficacy and safety of the intranasal vaccine against an FDA-approved mRNA-based COVID-19 vaccine.

The new vaccine is based on a viral delivery platform developed by He containing modified strains of parainfluenza virus 5, which causes kennel cough in dogs but is harmless to humans.

CyanVac was founded by Biao He, Regents’ Entrepreneur, Fred C. Davison Distinguished University Chair in Veterinary Medicine and a faculty member in UGA’s College of Veterinary Medicine (CVM). He served on a White House panel to advise on the future of COVID-19 vaccines and was named both UGA Inventor and Entrepreneur of the Year.

“We are very excited about this opportunity to test a novel intranasal COVID vaccine whose technology platform has been developed at UGA,” said He, who is based in UGA’s Department of Infectious Diseases. “The name of our vaccine—CVXGA—is a tribute to UGA and CVM whose support over the years made this possible.”

Project NextGen’s goal is to advance new, innovative vaccines and therapeutics that provide longer lasting and more durable protection against COVID-19. The award is one of the first made through the Rapid Response Partnership Vehicle, a consortium funded by the HHS Biomedical Advanced Research and Development Authority (BARDA) to accelerate product and technology development.

The Phase 2b study, which will begin this fall, will be carried out by BARDA’s Clinical Studies Network, focusing on evaluating the vaccine in a subset of participants who are at a higher risk of severe disease.

END

[Attachments] See images for this press release:

Intranasal COVID-19 vaccine headed to clinical trials 2

ELSE PRESS RELEASES FROM THIS DATE:

High out-of-pocket costs may be barrier to filling naloxone prescriptions, study shows

2024-06-14

Patients are less likely to fill prescriptions for naloxone when they face increases in out-of-pocket costs, according to U-M researchers. Patients are less likely to fill prescriptions for naloxone when they face increases in out-of-pocket costs, according to research by the University of Michigan. Published in the Journal of the American Medical Association, the study utilized data from a national pharmacy transactions database from November 2020 to March 2021. Researchers found that about 1 in 3 naloxone ...

Sharks have depleted functional diversity compared to the last 66 million years

2024-06-14

New research by Swansea University and the University of Zurich has found that sharks retained high levels of functional diversity for most of the last 66 million years, before steadily declining over the last 10 million years to its lowest value in the present day. Modern sharks are among the ocean’s most threatened species; yet have notably survived numerous environmental changes in their 250-million-year history. Today, their more than 500 species play many different ecological roles, from apex predators to nutrient transporters. Ecological roles are determined by species’ traits such as body size, ...

Fasting primes the immune system’s natural killer cells to better fight cancer, new study in mice finds

2024-06-14

Periods of fasting reprogram the immune system’s natural killer cells to better fight cancer, according to a new study in mice from researchers at Memorial Sloan Kettering Cancer Center (MSK). Fasting and other dietary regimens are increasingly being explored as ways to starve cancer cells of the nutrients they need to grow and to make cancer treatments more effective. Now a team of researchers from MSK’s Sloan Kettering Institute and their collaborators have shown for the ...

Are patient partners a necessity in research?

2024-06-14

Sjögren’s disease is a systemic autoimmune disorder that often causes sicca symptoms – or dryness of the eyes and mouth, alongside many other complications such as fatigue, pain, and neurological manifestations. There are treatments that help with symptoms, but none that address the underlying disease processes.3 One key issue in developing new treatments is that Sjögren’s can differ from person to person – and that makes it hard to measure and compare outcomes in a clinical trial. NECESSITY is an interventional trial looking at new clinical endpoints in Sjögren’s disease. ...

Encouraging cooperation in inflammatory arthritis

2024-06-14

Inflammatory arthritis describes a group of diseases caused by an overactive immune system. The different types of inflammatory arthritis include rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, and ankylosing spondylitis. The most common symptoms are joint pain and stiffness. Pain is the predominant symptom in the majority of people with inflammatory arthritis, which contributes to the global burden of rheumatic and musculoskeletal conditions.1 Knowledgeable support can reduce ...

Protection against disease and treatment toxicity

2024-06-14

Autologous hematopoietic stem cell transplantation (aHSCT) for SSc has been proven the most effective treatment strategy with regard to overall and event free survival in selected patients.2 But a key limitation is its toxicity, and new treatment options are needed. Two abstracts presented at the 2024 EULAR congress in Vienna focused on novel approaches. Jörg Henes presented on behalf of the AST MOMA investigators. This prospective, open-label, study evaluated the feasibility of aHSCT in patients with impaired lung or heart function, and also ...

Does BMO induced by mechanical stress progress to structural lesions?

2024-06-14

BMO in the sacroiliac joint on MRI is present in up to 84% of people with non-radiographic axSpA – but it is also often seen in a non-inflammatory setting, such as in women after childbirth.1,2 As back pain is common after childbirth, differential diagnosis with axSpA is an important issue in clinical practice.1 In axSpA, active inflammatory lesions are likely to progress to structural lesions over time – particularly fat lesions and erosions. But it is not known whether the same is true for BMO induced by mechanical stress. In June 2024, EULAR – The European Alliance of Associations for Rheumatology – held its annual congress ...

Is fish intake linked to JIA?

2024-06-14

In 2019, a Swedish prospective birth cohort study of over 15,000 children showed that consuming fish at least once a week during pregnancy and during the first year of life was associated with up to a 5-fold increased risk of JIA, compared to those with fish consumption less than once a week. This increased risk was primarily attributed to elevated exposure to heavy metals.1 Now, new research shared at the 2024 congress of EULAR – The European Alliance of Associations for Rheumatology – is investigating ...

Unpicking the complexity of systemic sclerosis

2024-06-14

SSc is a connective tissue disease with variable clinical presentation. It may affect the skin, blood vessels, heart, lungs, kidneys, gastrointestinal tract, and musculoskeletal system – and this complexity and diversity makes it challenging to treat.2 This clinical heterogeneity in SSc may be partially explained by SSc-specific antibodies, but a better understanding of additional risk factors and patient stratification is still needed. Three abstracts shared at the 2024 EULAR congress present a selection of new clinical research to enrich knowledge ...

Group tests novel therapeutic strategy to minimize progression of Duchenne muscular dystrophy

2024-06-14

In an animal model of Duchenne muscular dystrophy, Brazilian researchers tested a therapy that combines photobiomodulation using laser light or light-emitting diodes (LEDs) with idebenone, an antioxidant compound investigated for application in neurodegenerative diseases. As reported in an article published in the journal PLOS ONE, the strategy prevented muscle degeneration and improved regenerative capacity in the muscle fibers affected by the disease. Duchenne muscular dystrophy is the most common and most severe form of childhood muscular dystrophy and most often ...

Intranasal COVID-19 vaccine headed to clinical trials

ELSE PRESS RELEASES FROM THIS DATE:

LAST 30 PRESS RELEASES: