NIH Initiates Phase 1 Trial for Next-Generation Nasal COVID-19 Vaccine

The National Institutes of Health (NIH) has launched a Phase 1 trial for a novel nasal vaccine designed to offer broader protection against evolving variants of SARS-CoV-2, the virus responsible for COVID-19. This trial, sponsored by NIH’s National Institute of Allergy and Infectious Diseases (NIAID), is now actively recruiting healthy adults at different sites across the United States.

In a statement by NIAID Director Jeanne M. Marrazzo, the necessity of advancing beyond current COVID-19 vaccines was highlighted. While existing vaccines have been effective against severe disease outcomes, the emergence of new variants emphasizes the need for innovative solutions to combat infections and transmission.

The study seeks to enroll 60 adult participants who have received at least three previous doses of an FDA-approved or -authorized mRNA COVID-19 vaccine. The trial locations include Baylor College of Medicine in Houston, The Hope Clinic of Emory University in Decatur, Georgia, and New York University in Long Island. Dr. Hana M. El Sahly, leading the trial at Baylor College of Medicine Vaccine Research Center.

Participants will be sorted into three groups to receive varying dosages of the experimental vaccine in nasal spray form, with researchers monitoring its safety and immune response generation in blood and nasal tissues over a year-long period through multiple follow-up visits.

The investigational vaccine, called MPV/S-2P, utilizes murine pneumonia virus (MPV) as a vector to deliver a modified spike protein of SARS-CoV-2 in a prefusion conformation. MPV, harmless to humans and non-human primates, is adept at targeting respiratory tract cells where natural coronavirus infections take root.

Noteworthy is that this trial is part of the Project NextGen initiative by the U.S. Department of Health and Human Services (HHS). Project NextGen, overseen by the Biomedical Advanced Research and Development Authority and NIAID, aims to propel the development of new vaccines and therapeutics through collaborations between the government and private sector, focusing on Phase 1 and 2 trials for advanced COVID-19 solutions.

For further details on the trial and to access relevant information, interested individuals can visit the official ClinicalTrials.gov page with the specified identifier.

The National Institute of Allergy and Infectious Diseases (NIAID) functions to explore the origins and treatments of infectious and immune-related diseases through research efforts at various locations globally. More insights and resources related to NIAID can be found on their official website.