A nasal vaccine for covid-19-Based on Technology developed at washington university in st. Louis – is poised to enter a phase 1 clinical trial in the US after an investigational new drug application from Ocugen, Inc. was approved by the food and Drug Administration (FDA). Ocugen, a US-based biotechnology company, licensed the innovative technology from washu in 2022.

The trial will be conducted by the National Institute of Allergy and Infety Diseases (Niaid), of the National Institutes of Health (NIH). The FDA’s Action is a Critical Step Toward Initiation of the phase 1 trial, planned for this spring.

While cases of covid-19 have fallen dramatically since the early years of the pandemic, the virus continues to circulate and still causes significant illnesses and deaths. The nasal vaccine technology is designed to induce strong immunity in the nose and upper respiratory tract, right where the virus enters the body, thereby potentially stopping train IIUS Illness and Death.

Most Covid-19 vaccines are injected into the arm or leg, and while they are effective at Reducing Illness and Death, they do not halt transmission. The new trial will evaluate the safety and efficacy of the vaccine administerred via two routes: inhaled into the lungs and sprayed into the nose.

“I am delighted to see this nasal vaccination technology, Created by scientists right here at washu medicine, Advance Toward Clinical Trials,” Said Doug, Ph.D.D. Ization at washu.

“This powerful technology has the potential not only to help control covid-19 but Reduce the burden of Respiratory Infections Worldwide. The Technology COUDELOGY COUD ADAPTED FORS Asonal influenza, avian flu and respiratory syncytial virus (rsv) that Cause enormous Sickness and Death. “

A version of the vaccine has been available in India Since 2022 Through a licensing agreement between washuen washu and the Indian biotechnology company Bharat Biotech.

The trial will enroll 80 adults ages 18 to 64 years. Participants will be randomly assigned to one of four groups: low-dose intranasal, high-dose intranasal, low-dose inhaled and high-dose inhaled. The primary aim of the trial is to determine safety, but researchers will also also assess immunogenicity by measuring antibody production and efficacy by determining the number of breakthroups.

The Investigator Nasal Vaccine was co-Developed by washu medicine scientists Michael Ial Pathogens, and David T. Curiel, MD, Ph.D., The Distinguished Professor of Radiation Oncology, Along with members of their laborators.

Diamond and Curiel Inserted A Gene from Sars-Cov-2, The Virus That Causes Covid-19, Into a Harmless Virus Known as an adenovirus. The adenovirus carries the sars-cov-2 protein into the nose, enabling people to mount an immune defense against the sars-cov-2 virus with out being.

“It is gratifying to see the vaccine that we conceived, designed and condied initiative testing on move closer to becoming available here in the US,” said diamond, also a professor of molecular microobiology and path Immunology.

Diamond and Curiel’s early Studies at washu medicine showed that nasal delivery of this vaccine creates a strong immune response through the body, especially in the establishment. In Animal Studies Conducted In 2020 and 2021, The Nasal Vaccine Entrely Prevented Infection from Taking Hold in the Nose and Lungs – Suggesting that Vacinated Individuals Wouled Be Affele to FEND OF The Virus Before And cause an infection.

Last Year, JacCo Boon, Ph.D., A Professor of Medicine, of Molecular Microbiology and of Pathology & Immunology at washu medicine, showed that hamsters vaccine ly infected did not pass the virus on to others , Breaking the cycle of transmission.

“All Effective Vaccines Reduce Sickness and Death, But Covid-19 Vaccination through the nose and mouth also be also seems to reduce transmission,” Said curiel, also a professor of medicine and of the medicine and obster.

“This capability is critical in Spread of Respiratory Infections Spiratory viruses. “