The trial will evaluate safety, the effectiveness of the new generation vaccine given by nasal spray, inhalation
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A nasal vaccine for COVVI -19 – based on technology developed at Washington University in St. Louis – is about to enter a phase 1 clinical trial in the United States
A nasal vaccine for COVVI -19 – based on technology developed at Washington University in St. Louis – is about to enter a phase 1 clinical trial in the United States after a new request for medication survey ‘Orugen, Inc. was approved by food and administration medication (FDA). Orugen, a biotechnology company based in the United States, conceded Washu’s innovative technology in 2022.
The trial will be sponsored and directed by the National Institute of Diseases of Allergies and Infectious (NIAID), National Institutes of Health (NIH). The action of the FDA is a first critical step towards the initiation of phase 1 test, provided for this spring.
While the cases of COVID-19 have decreased spectacularly since the first years of the pandemic, the virus continues to circulate and always causes significant diseases and deaths. Nasal vaccine technology is designed to induce strong immunity in the nose and upper respiratory tract, where the virus enters the body, which has potentially stopped virus transmission in addition to reducing serious illnesses and death . Most COVVI-19 vaccines are injected into the arm or leg, and although they are effective in reducing disease and death, they do not stop transmission. The new test will assess the safety and effectiveness of the vaccine administered by two routes: inhaled in the lungs and pulverized in the nose.
“I am delighted to see this nasal vaccination technology, created by scientists here in Washu Medicine, advance to clinical trials,” said Doug E. Frantz, PhdThe vice-chancellor of innovation and marketing at Washu. “This powerful technology has the potential not only to help control COVID-19, but also to reduce the load of respiratory infections in the world. The technology could be adapted to other current respiratory viruses such as seasonal flu, avian flu and syncytial respiratory virus (RSV) which cause enormous disease and death. »»
A version of the vaccine was Available in India since 2022 Thanks to a license agreement between Washu and the Indian Biotechnology Biotechnology Biotech.
Phase 1 test is funded by Nextgen projectAn initiative of American government agencies to develop COVVI-19 vaccines and therapeutics of the new generation through public-private partnerships.
The trial will record 80 adults aged 18 to 64. Participants will be randomly assigned to one of the four groups: low -dose intranasal, high -dose intranasal, low -dose inhaled and high dose inhaled. The main objective of the trial is to determine security, but researchers will also assess immunogenicity by measuring the production and efficiency of antibodies by determining the number of COVVI-19 pierced cases.
The nasal vaccine sought was co-developed by scientists from Washu Medicine Michael S. Diamond, MD, PHDMedicine professor Herbert S. Gasser and co -director of the Center for Vaccines & Immunity to Microbial Pathogenic, and David T. Curiel, MD, PHDThe eminent teacher of radiotherapy, as well as members of their laboratories.
Diamond and Curiel inserted a SARS-COV-2 gene, the virus that causes COVID-19, in a harmless virus known as adenovirus. Adenovirus bears the Sars-Cov-2 protein in the nose, allowing people to set up an immune defense against the Sars-Cov-2 virus without becoming sick.
“It is rewarding to see the vaccine that we have designed, designed and carried out initial tests on getting closer to becoming available here in the United States,” said Diamond, also a teacher of molecular microbiology and pathology and immunology.
The first studies of Diamond and Curiel in Washu Medicine have shown that the nasal delivery of this vaccine creates a strong immune response throughout the body, especially in the nose and the respiratory tract. In animal studies carried out in 2020 and 2021, the nasal vaccine completely prevented the infection from settling in the nose and the lungs – suggesting that vaccinated individuals could repel the virus before it can multiply and cause a infection. Last year, Jacco Boon, PHDProfessor of medicine, molecular microbiology and pathology and immunology in Washu Medicine, showed that hamsters vaccinated with the COVVI-19 nasal vaccine and infected thereafter did not transmit the virus to othersBreaking the transmission cycle.
“All effective vaccines reduce disease and death, but COVVI-19 vaccination by nose and mouth also seems to reduce transmission,” said Curiel, also a professor of medicine and obstetrics and gynecology. “This capacity is essential to slow down the spread of respiratory infections such as COVVI-19 through a population, and the same vaccination technology can be designed to target other COVID-19 strains as well as flu and other respiratory viruses . “