The new nasal vaccine for Covid-19 continues a clinical trial in the USA

The new nasal vaccine for Covid-19 continues a clinical trial in the USA

A nasal vaccine against Covid-19 - based on technology developed at Washington University in St. Louis - is ready to complete a Phase 1 clinical trial in the US after a new drug application from Ocugen, Inc. was approved by the Food and Drug Administration (FDA). Ocugen, a US-based biotechnology company, licensed Washu's innovative technology in 2022.

The trial is sponsored and conducted by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH). The FDA's action is a critical first step toward initiating the Phase 1 trial scheduled 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 illness and death. Nasal vaccine technology is designed to induce strong immunity in the nose and upper respiratory tract, exactly where the virus enters the body, thereby potentially stopping transmission of the virus and reducing serious illness and death. Most Covid-19 vaccines are injected into the arm or leg, and although they reduce illness and death, they do not stop transmission. The new study will evaluate the safety and effectiveness of the vaccine, which is administered via two routes: inhaled into the lungs and sprayed into the nose.

I am very excited to see this nasal vaccination technology created by scientists here at Washu Medicine advance to clinical trials. This powerful technology has the potential to not only control Covid-19 but also reduce the burden of respiratory infections worldwide. The technology could be adapted for other common respiratory viruses such as seasonal influenza, bird flu and respiratory syncytial virus (RSV), which cause enormous illness and death. “

Doug E. Frantz, PhD, vice chancellor for innovation and commercialization at Washu

A version of the vaccine has been available in India since 2022 through a licensing agreement between Washu and Indian biotechnology company Bharat Biotech.

The Phase 1 study is funded by Project NextGen, a U.S. government agency initiative to develop next-generation COVID-19 vaccines and therapeutics through public-private partnerships.

The study will enroll 80 adults ages 18 to 64. Participants will be randomly assigned to one of four groups: low-dose intranasal, high-dose intranasal, low-dose inhaled, and high-dose inhaled. The main aim of the study is to determine safety, but researchers will also assess immunogenicity by measuring antibody production and effectiveness by determining the number of breakthrough cases of Covid-19.

The Investigational Nasal Vaccine was co-developed by Washu Medicine scientists, MD, MD, PhD, Herbert S. Gasser Professor of Medicine and co-director of the Center for Vaccines and Immunity to Microbial Pathogens, and David T. Curiel, MD, PhD, The Distinguished Professor of Radiation, along with members of the laboratories.

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, allowing people to mount immune defenses against the SARS-CoV-2 virus without getting sick.

“It is gratifying to see the vaccine that we conceived, designed and implemented to be brought closer to home here in the United States,” said Diamond, also a professor of molecular microbiology and pathology and immunology.

Diamond and Curiel's early studies in Washu medicine showed that nasal delivery of this vaccine creates a strong immune response throughout the body, particularly in the nasal and respiratory tract. In animal studies conducted in 2020 and 2021, the nasal vaccine completely prevented infection in the nose and lungs, suggesting vaccinated people could shed the virus before it could multiply and cause an infection. Last year, Jacco Boon, PhD, professor of medicine, molecular microbiology and pathology and immunology in Washu Medicine, showed that hamsters vaccinated with the nasal Covid-19 vaccine and subsequently infected the virus passed on to others, breaking the cycle of transmission.

“All effective vaccines reduce illness and death, but Covid-19 vaccination through the nose and mouth also appears to reduce transmission,” said Curiel, also a professor of medicine and obstetrics and gynecology. “This ability is critical to slowing the spread of respiratory infections such as Covid-19 through a population, and the same vaccine technology can be designed to target other CoVID-19 strains as well as influenza and other respiratory viruses.”

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