Phase 1 Clinical Trial for Intranasal COVID-19 Vaccine Against Emerging SARS-CoV-2 Variants
Author: NIH/National Institute of Allergy and Infectious Diseases
Published: 01/07/2024
Type of publication: Advertisement
Content: Summary – Introduction – Major – Related
Synopsis: A new nasal vaccine candidate could provide increased protection against emerging SARS-CoV-2 variants. 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. While first-generation COVID-19 vaccines remain effective at preventing severe illness, hospitalization, and death, they are less successful at preventing infections and milder forms of the disease. With the continued emergence of new variants of the virus, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce SARS-CoV-2 infections and transmission.
Introduction
Healthy adults are being enrolled at three U.S. sites in a Phase 1 trial testing the safety of an investigational nasal vaccine that may provide increased protection against emerging variants of SARS-CoV-2, the virus that causes COVID-19. The National Institutes of Health (NIH) is sponsoring the first-in-human trial of the investigational vaccine, which was designed and tested in preclinical studies by scientists in the Infectious Diseases Laboratory at NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
Main Summary
“The rapid development of safe and effective COVID-19 vaccines was a triumph of science, and their use greatly mitigated the effects of the pandemic,” said NIAID Director Jeanne M. Marrazzo, MD, MPH.
“While first-generation COVID-19 vaccines remain effective at preventing severe disease, hospitalization, and death, they are less successful at preventing infections and milder forms of the disease. With the continued emergence of new variants of the virus, there is a critical need to develop next-generation COVID-19 vaccines, including nasal vaccines, that could reduce infections and transmission of SARS-CoV-2.”
The study aims to enroll 60 adult participants, ages 18-64, who have previously received at least three prior doses of an FDA-approved or authorized mRNA COVID-19 vaccine.
Testing sites are:
- Baylor College of Medicine, Houston
- Emory University Hope Clinic, Decatur, Georgia
- New York University, Long Island
Dr. Hana M. El Sahly of the Vaccine Research Center at Baylor College of Medicine led the study.
Study volunteers will be divided into three cohorts. Those in the first cohort will receive one dose of the candidate vaccine delivered by nasal spray at the lowest dose, and those enrolled in the next two cohorts will receive progressively higher doses. During seven follow-up visits over about a year, scientists will measure how well the candidate vaccine is tolerated and whether it generates an immune response in the blood and nose.
Continued…
The candidate 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 nonhuman primates, but has an affinity for epithelial cells lining the respiratory tract and may be effective for delivering the vaccine to sites where natural coronavirus infections begin.
In preclinical studies in nonhuman primates, MPV/S-2P was safe and well tolerated. It produced robust systemic immune responses, including antibodies directed against SARS-CoV-2, as well as local immunity in cells of 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 the replication of respiratory viruses.
This is the first NIAID clinical trial being 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 HHS’ Strategic Preparedness and Response Administration, and NIAID, Project NextGen is a coordinated effort between the federal government and the private sector to expand the pipeline of innovative new vaccines and therapeutics. Through Project NextGen, NIAID plans to facilitate the 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.
Related information of interest
Attribution/Source(s):
This quality-reviewed publication entitled Phase 1 clinical trial for intranasal COVID-19 vaccine against emerging SARS-CoV-2 variants The editors of Disabled World selected this book for publication because of its relevance to the disabled community. While the content may have been edited for style, clarity, or brevity, its original author was NIH/National Institute of Allergy and Infectious Diseases and published on 01/07/2024. For further details or clarifications, you can contact NIH/National Institute of Allergy and Infectious Diseases directly at www.niaid.nih.gov Disabled World does not offer any warranty or endorsement related to this article.
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Cite this page (APA): NIH/National Institute of Allergy and Infectious Diseases. (July 1, 2024). Phase 1 clinical trial for intranasal COVID-19 vaccine against emerging SARS-CoV-2 variants. Disabled worldRetrieved July 2, 2024 from www.disabled-world.com/medical/clinical-trials/nasal-vaccine-trial.php
Permanent link: Phase 1 clinical trial for intranasal COVID-19 vaccine against emerging SARS-CoV-2 variants: A new nasal vaccine candidate could provide greater breadth of protection against emerging SARS-CoV-2 variants.
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