National Institutes of Health Initiates Phase I Trial to Test the Safety of an Experimental Nasal COVID-19 Vaccine

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The National Institutes of Health (NIH) has begun a Phase I clinical trial to test the safety of an experimental nasal COVID-19 vaccine designed to provide enhanced protection against emerging variants of SARS-CoV-2. The trial, which has been developed by the National Institute of Allergy and Infectious Diseases (NIAID), intends to improve upon current limitations associated with first-generation COVID vaccines regarding the prevention of infections and milder diseases.¹

“The rapid development of safe and effective COVID-19 vaccines was a triumph of science, and their use greatly mitigated the toll of the pandemic,” said Jeanne M. Marrazzo, MD., MPH, director, NIAID, in a press release. “While first-generation COVID-19 vaccines continue to be effective at preventing severe illness, hospitalizations, and death, they are less successful at preventing infection and milder forms of disease. With the continual emergence of new virus variants, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce SARS-CoV-2 infections and transmission.”

The study, which has an enrollment goal of 60 individuals between the ages of 18 and 64 years old who previously received at least three prior doses of an FDA-approved or -authorized mRNA COVID-19 vaccine, will have sites at Baylor College of Medicine, The Hope Clinic of Emory University, and New York University.1

“Study volunteers will be divided into three cohorts. Those in the first cohort will receive one dose of the investigational vaccine delivered in a nasal spray at the lowest dosage, with enrollees in the next two cohorts receiving progressively higher doses. During seven follow-up visits over about one year, scientists will measure how well the vaccine candidate is tolerated, and if it generates an immune response in the blood and in the nose,” reports NIH.

The trial will assess MPV/S-2P using murine pneumonia virus (MPV) as a vector to deliver a stabilized version of the SARS-CoV-2 spike protein. MPV/S-2P demonstrated safety and robust immune responses in pre-clinical studies, and the trial measuring its safety is part of the US Department of Health and Human Services' Project NextGen, which works to advance the development of innovative COVID-19 vaccines and therapeutics.¹

According to John Hopkins University (JHU), its engineers have created thin, threadlike strands of molecules called supramolecular filaments, designed to block viruses such as COVID from entering the lungs through being sprayed into the nose.²

“The idea is that the filaments will work like a sponge to absorb the COVID-19 virus and other viruses before they have the chance to bind to cells in our airways. Even if the therapeutic can block the virus for an hour or two, that can be helpful when people must be in a public setting," said Honggang Cui, core researcher, Institute for NanoBioTechnology, associate professor, chemical and biomolecular engineering, Johns Hopkins Whiting School of Engineering, in an interview with JHU’s Gina Wadas. “Our plan is that this would be administered as a nasal or oral spray, allowing it to be suspended in the lungs or settle on the surface of airways and lungs. When a person breathes in the COVID-19 virus, the virus will be fooled into binding to the decoy receptor and not the ACE2 receptors on cells.”

The Centers for Disease Control and Prevention (CDC) recommends that everyone over the age of 6 years old should stay up to date on COVID vaccinations.³

References

1. NIH-sponsored trial of nasal COVID-19 vaccine opens. NIH. July 1, 2024. Accessed July 2, 2024. https://www.nih.gov/news-events/news-releases/nih-sponsored-trial-nasal-covid-19-vaccine-opens

2. A SIMPLE SPRAY COULD KEEP COVID-19 AWAY. John Hopkins University. January 12, 2023. Accessed July 2, 2024. https://hub.jhu.edu/2023/01/12/nasal-spray-prevents-spread-covid-flu/

3. Vaccination Trends—Adults. CDC. June 28, 2024. Accessed July 2, 2024. https://www.cdc.gov/respiratory-viruses/data-research/dashboard/vaccination-trends-adults.html