Breaking News
August 18, 2018 - Immigrants Not a Burden on U.S. Health Care: Study
August 18, 2018 - Women who eat fast food take longer to become pregnant
August 18, 2018 - Most YouTube videos on plastic surgery are misleading marketing campaigns
August 18, 2018 - The essential guide to make your laboratory more sustainable
August 18, 2018 - Researchers describe promising strategy to remove melanoma’s most powerful defenses
August 18, 2018 - Women with polycystic ovary syndrome dissatisfied with medical care
August 18, 2018 - Research discoveries reveal insights behind neurological degeneration
August 18, 2018 - Researchers win multi-million Euro award to conduct research into liver disease
August 18, 2018 - Survey highlights variations in practice of airway management in pediatric intensive care units
August 18, 2018 - UK students win sponsorship from Promega Corporation
August 18, 2018 - Janssen Reports Positive Topline Results for ATLAS Phase III Study of a Novel, Long Acting Injectable Two-Drug Regimen for the treatment of HIV-1
August 18, 2018 - PSD as a molecular platform for understanding synapse formation and plasticity
August 18, 2018 - Improved visual communication could help patients to make informed health-care decisions
August 18, 2018 - New algorithm helps identify and manage diabetic patients at increased fracture risk
August 18, 2018 - Microscopic insect odour detecting mechanisms discovered
August 18, 2018 - Researchers develop new approach to study how tuberculosis infects people
August 18, 2018 - FDA Approves Kalydeco (ivacaftor) for Cystic Fibrosis in Children Ages 12 to
August 18, 2018 - An ion channel differentiates newborn and mature neurons in the adult brain
August 18, 2018 - Socio-economic position associated with pregnant women’s exposure to environmental hazards
August 18, 2018 - Voters to settle dispute over ambulance employee break times
August 18, 2018 - AGA urges policymakers and stakeholders to improve affordability of drugs
August 18, 2018 - Increasing dietary protein may lower risk of diabetes in people with NAFLD
August 18, 2018 - New HIV therapy suppresses viral replication and increases immune cells in drug-resistant patients
August 18, 2018 - Broad Genetic Testing for NSCLC May Not Improve Survival
August 18, 2018 - Discovery opens door for synthetic opioids with less addictive qualities
August 18, 2018 - Transgenic rice plant extracts could help stop the spread of HIV
August 18, 2018 - Hologic’s Cynosure division partners with Porter Instrument to distribute nitrous oxide and oxygen system
August 18, 2018 - Two thyroid medications recalled by FDA
August 18, 2018 - Forecast Sees Abnormal Heat Worldwide Through 2022
August 18, 2018 - Childhood absence epilepsy – Genetics Home Reference
August 18, 2018 - Fearing hard Brexit, UK drugmakers stockpile to protect lives
August 18, 2018 - Discovery may help broaden the scope of defenses against HPV
August 18, 2018 - When they start thinking green, they see green
August 18, 2018 - Scientists introduce microfluidics-based chip for manipulation and analysis of single cells
August 18, 2018 - Researchers design new way to grow nose cells for treating spinal cord injuries
August 18, 2018 - New light shed on relationship between calorie-burning fat and muscle function
August 18, 2018 - Surgery Saturday Instagram series takes you inside Stanford’s OR
August 18, 2018 - Researchers uncover surprising new role for inhibition in the cerebellum
August 18, 2018 - Children have better nutrition when they live near forests, global study shows
August 18, 2018 - OHSU professor conducts clinical trial with artificial pancreas using Xeris’ liquid glucagon
August 18, 2018 - HSS takes young patients with physical challenges on a surfing trip
August 18, 2018 - Study shows electronic health records leave doctors and patients unsatisfied
August 18, 2018 - Study uncovers mechanism that affects multiplication of dengue virus lineage
August 18, 2018 - UTHealth safety expert talks about preparing for the most destructive hurricanes
August 18, 2018 - Theravance Biopharma Reports Positive Top-Line Four-Week Data from Phase 2 Trial of TD-9855 for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension
August 18, 2018 - Animations prove effective in accurately measuring pain
August 18, 2018 - Three faculty members appointed to endowed positions | News Center
August 18, 2018 - New technique detects, measures, analyzes unevenly charged biomolecules
August 18, 2018 - Brief exposures to stressors can be beneficial to cells, shows study
August 18, 2018 - UTHealth-led survey shows much work remains to increase safety of e-health records
August 18, 2018 - Researchers use super-resolution microscope to unravel secrets of deadly Nipah virus
August 18, 2018 - Scientists identify pathways that reveal insights into mechanism of lung cancer etiology
August 18, 2018 - Rush’s health care IT leaders reach White House
August 18, 2018 - FDA approves marketing of brainsway deep transcranial magnetic stimulation system for OCD
August 17, 2018 - OUHSC gets $20 million grant to advance research and patient care for Oklahomans
August 17, 2018 - Sperm morphology differs depending on qualities of male bird
August 17, 2018 - Texas A&M researchers develop clay-based platform to grow blood vessels
August 17, 2018 - FDA Approves Expanded Indication for Orkambi (lumacaftor/ivacaftor) in Children Ages 2-5 Years
August 17, 2018 - Caring for Concussions | NIH News in Health
August 17, 2018 - Team explores diabetes drug’s ability to treat RSV infection
August 17, 2018 - New imaging technique can spot tuberculosis infection in an hour | News Center
August 17, 2018 - PolyU researchers design new self-fitting scaffold to induce bone regeneration
August 17, 2018 - CartiHeal and LSU Health successfully enroll first two patients in Agili-C IDE pivotal study
August 17, 2018 - Less-invasive options are slowing disease progression in glaucoma patients
August 17, 2018 - Researchers discover new promising target point for cancer and diabetes therapies
August 17, 2018 - Podcast: KHN’s ‘What the Health?’ See you in court!
August 17, 2018 - New mobile phone application enables early detection of cerebral ictus
August 17, 2018 - AJMC addresses role of community pharmacies in boosting adult vaccination rates
August 17, 2018 - UK’s leading sight loss charity invites applications from brightest minds in ophthalmic research
August 17, 2018 - Alternative devices can help when autoinjectors are unavailable
August 17, 2018 - Researchers produce artificial placenta model that closely resembles natural organ
August 17, 2018 - Study offers possibility of squelching a focal epilepsy seizure before symptoms appear
August 17, 2018 - FDA Alert: Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers
August 17, 2018 - New statewide program in North Dakota aims to stem opioid misuse
August 17, 2018 - Researchers discover why sepsis from a staph infection causes organ failure
August 17, 2018 - Stony Brook University’s new medical students start a transformative journey
August 17, 2018 - Revealed: The molecular mechanism underlying hypertrophic cardiomyopathy | News Center
August 17, 2018 - New modeling studies highlight urgent need for effective drug policy reforms to prevent HIV
August 17, 2018 - Research explores relationship between personal history of infectious fever and cancer risk
August 17, 2018 - Study finds rise in cases of progressive massive fibrosis among U.S. coal miners
Firm advances human trials of revolutionary vaccine

Firm advances human trials of revolutionary vaccine

image_pdfDownload PDFimage_print
Yoshihiro Kawaoka, professor of pathobiological sciences in the School of Veterinary Medicine and a co-founder of FluGen, gives a slide presentation to a group of media representatives touring the Influenza Research Institute. Credit: Jeff Miller

Amid predictions that this year’s flu vaccine will offer limited protection, medical researchers are renewing their focus on a universal flu vaccine.

A universal flu vaccine would offer more broad protection than today’s vaccines, which must be targeted at viral strains deemed dangerous many months before flu season begins.

The problem is that the flu virus can change fast enough to evade those vaccines.

No versatile influenza vaccine is on the market, but one of the most promising is being developed by FluGen, a spinoff from the University of Wisconsin–Madison. The Madison startup has announced a plan to evaluate its innovative influenza vaccine in a trial of 100 people later this spring.

For almost a decade, the company has been exploring a genetically altered virus that can reproduce only once in the human body. “Our vaccine contains a live virus that infects you but cannot make you sick,” says CEO Paul Radspinner.

Viruses reproduce by hijacking cellular machinery. The essential technology for Flugen’s project deletes a gene the virus needs to reproduce more than once. The discovery was made in 2002 by company co-founders Yoshihiro Kawaoka, an internationally known influenza researcher at the School of Veterinary Medicine, and his colleague Gabrielle Neumann.

The principle that an infection can be powerful medicine, however, is much older, Radspinner says. “Our vaccine is based on the concept that if you get the flu this year, the odds that you will get it next year go down dramatically.”

Beyond creating a real but extremely limited infection, Flugen’s invention also uses a promising delivery route. Instead of being injected into the muscle, it will be squirted into the nose, which is far more faithful to a natural infection. “If you think how you get the flu. It’s usually through the nasal passages or the throat,” Radspinner says.

Intranasal delivery triggers immunity in the mucus been shown to “activates multiple immune systems in the body, while the traditional shot in the arm affects primarily the antibody-based immune system.”

Influenza is a global disease caused by a group of viruses that change rapidly and spread easily through coughs and sneezes. Worldwide, the disease kills between 250,000 and 500,000 per year. Due to the long lead time needed to produce vaccine in eggs, public-health authorities must choose vaccine for the northern hemisphere in February.

During the nine or more months before flu season begins, the virus undergoes “genetic drift” as it evolves and reasserts its genetics. Such drift is a major reason why, even in healthy adults, influenza vaccines are only 10 to 60 percent protective.

FluGen’s vaccine is made in mammalian cells, not eggs, so faster production should allow less time for genetic drift. Unlike the current vaccine, the virus is alive, and therefore more likely to trigger immunity. Already, FluGen has shown that the vaccine triggers a much broader immune response, affecting not just the mucus tissues but also B-cells, T-cells and antibodies.

FluGen’s technology is protected by multiple patents held by both the Wisconsin Alumni Research Foundation and FluGen.

A test in healthy adults, completed in 2016, showed no warning flags related to safety, “and it told us we are hitting many sections of the immune system,” Radspinner says.

Those results helped to justify a $14.4 million grant awarded by the Department of Defense to test whether a vaccine based on a 2009 strain of flu can protect against the strains that circulated in 2014-15. “We’re aiming to prove effectiveness after six years of genetic drift,” says Radspinner. “That’s a big mismatch.”

Half of the 100-odd volunteers in the upcoming study will get a saline squirt in the nose; the others will get FluGen’s vaccine. Later, everyone will get a nasal dose of live flu virus. “They’ll be in ‘flu camp’ for 11 days in an isolation facility in Belgium,” Radspinner says. “We will measure how well our vaccine protected against the flu challenge, based on infection and symptoms, and we’ll look at a broad range of safety indicators as well.”

The goal is to have initial results by the end of the year.

Despite the dual benefits from faster vaccine production and broader immunity, regulatory approval is expected to entail safety-efficacy trials involving several thousand people. “With any vaccine, safety is the paramount issue, so the FDA [Food and Drug Administration] wants to see as many subjects as possible,” Radspinner says.

Depending on the scientific results, and regulatory approval, 2025 is a reasonable time for gaining FDA approval and reaching the market, he says.

As FluGen’s dozen employees prepare for the larger trials, the company has begun to use more outside resources, including specialized manufacturers that are not found locally. “We are a semi-virtual company,” says Radspinner. “We have half of our employees doing basic research and development in the lab, and we coordinate external clinical research and manufacturing through outside organizations.”

Influenza can be extraordinarily dangerous, and flu researchers are haunted by the 1917-18 pandemic, which killed 50 to 100 million people worldwide. Public-health authorities continue to promote the benefits of flu vaccine, but the protection is better in some years than others, Radspinner says. “It may be too early to tell, but the early surveillance, an area where Wisconsin has long been a leader, clearly indicates that this is going to be strong year for flu.”

Even though getting the flu is your best protection against another bout, “Who wants to get sick for a couple of weeks?” he asks. “Our goal is to trick the body into thinking that it’s infected, so you get protected, without getting the symptoms that are the historic price of protection.”


Explore further:
Strategy introduces stable components of flu virus for long-lasting, DNA-enhanced protection

Provided by:
University of Wisconsin-Madison

Tagged with:

About author

Related Articles