Clinical trials for a nasal COVID-19 vaccine have commenced.

The Food and Drug Administration (FDA) has approved a research application for a new drug from Ocugen, Inc., an American biotechnology company that has registered a license for innovative technology at the University of Washington.

The trials will be conducted by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The FDA's decision marks a significant first step towards initiating human trials scheduled for this spring.

Although the number of COVID-19 cases has significantly decreased compared to the early years of the pandemic, the virus continues to circulate and still causes a considerable number of illnesses and deaths. The nasal vaccine technology is designed to stimulate a robust immune response in the nose and upper respiratory tract, which is precisely where the virus enters the body, potentially halting virus transmission and reducing the incidence of severe illness and death.

Most COVID-19 vaccines are administered in the arm or leg, and while they effectively reduce morbidity and mortality, they do not stop the transmission of the infection. The new trial will assess the safety and efficacy of the vaccine administered in two ways: inhalation into the lungs and nasal spray.

“I am excited to see the nasal vaccination technology developed by scientists at the University of Washington Medicine advancing to clinical trials,” said Doug E. Frantz, PhD, Vice Provost for Innovation and Commercialization at the University of Washington. “This powerful technology has the potential not only to aid in the fight against COVID-19 but also to 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 significant number of illnesses and deaths.

The trial will involve 80 adult participants aged 18 to 64. Participants will be randomly assigned to one of four groups: low-dose intranasal drug, high-dose intranasal drug, low-dose inhalation drug, and high-dose inhalation drug. The primary aim of the study is to determine safety, but researchers will also evaluate immunogenicity by measuring antibody production and efficacy by assessing the number of COVID-19 cases.

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

The adenovirus carries the SARS-CoV-2 protein to the nose, allowing individuals to develop immune protection against the SARS-CoV-2 virus and prevent illness.

Initial studies by researchers at the University of Washington Medicine demonstrated that the nasal delivery of this vaccine elicits a strong immune response throughout the body, particularly 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 individuals could resist the virus before it has a chance to replicate and cause infection.

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

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

This capability is crucial for slowing the spread of respiratory infections like COVID-19 among the population, and this same vaccine technology could be developed to combat other COVID-19 strains, as well as influenza and other respiratory viruses.