A Phase 1 clinical trial has commenced to assess an experimental nasal vaccine designed to protect against emerging variants of SARS-CoV-2, the virus responsible for Covid-19. Led by scientists from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), this trial aims to evaluate the safety and efficacy of the new vaccine delivery method.
Dr. Jeanne M. Marrazzo, Director of NIAID, emphasized the critical need for next-generation vaccines amidst the evolving landscape of Covid-19 variants. She highlighted that while current vaccines have been effective in preventing severe illness and death, they have shown limitations in stopping infections and mild cases. The development of nasal vaccines, she added, could potentially reduce infections and transmission rates, particularly with the emergence of new virus variants.
The trial is currently enrolling 60 healthy adults aged 18 to 64 at three locations across the United States: Baylor College of Medicine in Houston, The Hope Clinic of Emory University in Decatur, Georgia, and New York University on Long Island. Participants must have previously received at least three doses of an FDA-approved mRNA Covid-19 vaccine.
Led by Dr. Hana M. El Sahly at Baylor College of Medicine, the trial participants will be divided into three groups, each receiving varying doses of the experimental nasal spray vaccine. Over the course of a year, researchers will closely monitor the vaccine's safety profile and its ability to elicit immune responses both in the bloodstream and within nasal tissues.
Details of the Nasal Vaccine
The investigational vaccine, known as MPV/S-2P, employs murine pneumonia virus (MPV) as a vector to deliver a stabilized version of the SARS-CoV-2 spike protein. MPV does not cause disease in humans but targets respiratory cells, potentially enhancing the delivery of the vaccine to the respiratory tract.
Prior pre-clinical studies conducted in non-human primates demonstrated that MPV/S-2P was safe and well-tolerated, inducing robust immune responses in both systemic circulation and mucosal tissues of the respiratory tract. This suggests that the vaccine could stimulate effective mucosal immunity in the nose and throat, which is crucial for combating respiratory viruses.
The initiation of this Phase 1 trial marks an important step in advancing the development of nasal Covid-19 vaccines, aiming to bolster the arsenal against the ongoing pandemic by potentially enhancing vaccine efficacy and broadening protection against emerging variants of SARS-CoV-2.
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