Clinical trials of a nasal vaccine for COVID-19 have begun

A nasal vaccine against COVID-19, based on technology developed at Washington University in St. Louis, is ready for Phase 1 clinical trials in the United States. The Food and Drug Administration (FDA) has approved a study application for the new drug from Ocugen, Inc. a US biotechnology company that has registered a license for the innovative technology at Washington University.

The trial will be conducted by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The FDA’s decision is an important first step toward the start of human trials scheduled for this spring.

Although the number of COVID-19 cases has decreased significantly from the first few years of the pandemic, the virus continues to circulate and still causes a significant number of illnesses and deaths. Nasal vaccine technology is designed to stimulate expressed immunity in the nose and upper respiratory tract, exactly where the virus enters the body, thereby potentially stopping transmission of the virus as well as reducing serious illness and death.

Most COVID-19 vaccines are injected into the arm or leg, and while they are effective in reducing morbidity and mortality, they do not stop transmission. The new trial will evaluate the safety and efficacy of the vaccine administered by two routes: inhalation into the lungs and spraying into the nose.

“I am pleased to see the nasal vaccination technology created by scientists at the University of Washington School of Medicine move toward clinical trials,” said Doug E. Frantz, PhD, vice chancellor for innovation and commercialization at the University of Washington. – “This powerful technology has the potential to not only help fight COVID-19, but also reduce the burden of respiratory infections worldwide.

The technology can be adapted to combat other common respiratory viruses such as seasonal influenza, avian influenza and respiratory syncytial virus (RSV), which cause a tremendous amount of illness and death.

The trial will enroll 80 adults between the ages of 18 and 64. Participants will be randomly assigned to one of four groups: a low-dose intranasal preparation, a high-dose intranasal preparation, a low-dose inhalation preparation, and a high-dose inhalation preparation. The primary goal of the study is to determine safety, but researchers will also evaluate immunogenicity by measuring antibody production and efficacy by determining the number of cases of COVID-19 infection.

The nasal vaccine under study was developed by scientists at WashU Medicine who inserted the gene from the SARS-CoV-2 virus that causes COVID-19 into a harmless adenovirus.

The adenovirus carries the SARS-CoV-2 protein into the nose, which helps create immune protection against the SARS-CoV-2 virus in people and prevent disease.

Initial studies by scientists at the Medical University of Washington have shown that nasal delivery of this vaccine induces a strong immune response throughout the body, especially in the nose and respiratory tract. In animal studies, the nasal vaccine completely prevented the infection from entering the nose and lungs, suggesting that vaccinated people will be able to resist the virus before it has a chance to multiply and cause infection.

Last year, scientists in preclinical studies found that hamsters vaccinated with the nasal COVID-19 vaccine and subsequently infected with the virus did not transmit the virus to other animals, breaking the transmission cycle.

All effective vaccines reduce morbidity and mortality, but vaccinating COVID-19 through the nose and mouth also appears to reduce transmission.

This ability is critical to slowing the spread of respiratory infections such as COVID-19 in the population, and this same vaccine technology could be developed to combat other strains of COVID-19 as well as influenza and other respiratory viruses.

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Published: 06.02.2025

Updated: 06.02.2025

Medical author, Medical editor:

Stepan Yuk

Medical expert:

PhD. Olexandr Voznyak