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       NIH-sponsored trial of nasal COVID-19 vaccine opens
        
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       News Release
        
       Monday, July 1, 2024
        
       # NIH-sponsored trial of nasal COVID-19 vaccine opens
        
       Candidate vaccine could provide enhanced breadth of protection against
       emerging SARS-CoV-2 variants.
        
       A Phase 1 trial testing the safety of an experimental nasal vaccine
       that may provide enhanced breadth of protection against emerging
       variants of SARS-CoV-2, the virus that causes COVID-19, is now
       enrolling healthy adults at three sites in the United States. The
       National Institutes of Health (NIH) is sponsoring the first-in-human
       trial of the investigational vaccine, which was designed and tested in
       pre-clinical studies by scientists from NIH's National Institute of
       Allergy and Infectious Diseases (NIAID) Laboratory of Infectious
       Diseases.
        
       "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 NIAID Director Jeanne M. Marrazzo, M.D., M.P.H. "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 aims to enroll 60 adult participants, ages 18 to 64 years
       old, who previously received at least three prior doses of an FDA-
       approved or -authorized mRNA COVID-19 vaccine. The trial sites are
       Baylor College of Medicine, Houston; The Hope Clinic of Emory
       University, Decatur, Georgia; and New York University, Long Island.
       Hana M. El Sahly, M.D., at the Baylor College of Medicine Vaccine
       Research Center, is leading the study.
        
       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.
        
       The investigational vaccine, MPV/S-2P, uses murine pneumonia virus
       (MPV) as a vector to deliver a version of the SARS-CoV-2 spike protein
       (S-2P) stabilized in its prefusion conformation. MPV does not cause
       disease in humans or non-human primates but does have an affinity for
       epithelial cells that line the respiratory tract and may be effective
       in delivering vaccine to the places where natural coronavirus
       infections begin.
        
       In pre-clinical non-human primate studies, MPV/S-2P was safe and well
       tolerated. It produced robust systemic immune responses, including
       SARS-CoV-2-directed antibodies, as well as local immunity in cells in
       the mucosal tissues lining the nose and respiratory tract. Studies in
       humans and animals suggest that mucosal immunity is more effective
       than systemic immunity in controlling replication of respiratory
       viruses.
        
       This is the first NIAID clinical trial to be conducted as part of the
       U.S. Department of Health and Human Services (HHS) Project NextGen.
       Led by the Biomedical Advanced Research and Development Authority,
       part of the HHS Administration for Strategic Preparedness and
       Response, and NIAID, Project NextGen is a coordinated effort between
       the federal government and the private sector to broaden the pipeline
       of new, innovative vaccines and therapeutics. Through Project NextGen,
       NIAID plans to facilitate clinical development of promising next-
       generation COVID-19 vaccines in Phase 1 and 2 trials.
        
       More information about the trial is available at clinicaltrials.gov
       using the identifier NCT06441968.
        
       NIAID conducts and supports research — at NIH, throughout the United
       States, and worldwide — to study the causes of infectious and immune-
       mediated diseases, and to develop better means of preventing,
       diagnosing and treating these illnesses. News releases, fact sheets
       and other NIAID-related materials are available on the NIAID website.
        
        **About the National Institutes of Health (NIH):** NIH, the nation's
       medical research agency, includes 27 Institutes and Centers and is a
       component of the U.S. Department of Health and Human Services. NIH is
       the primary federal agency conducting and supporting basic, clinical,
       and translational medical research, and is investigating the causes,
       treatments, and cures for both common and rare diseases. For more
       information about NIH and its programs, visit www.nih.gov.
        
       _NIH…Turning Discovery Into Health ®_
        
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