Participants in the trial will be grouped into three cohorts to receive one dose of the nasal spray vaccine at varying dosages. Credit: The NIAID Integrated Research Facility (IRF) in Fort Detrick, Maryland / National Institutes of Health.

The US National Institutes of Health (NIH) has announced the start of subject enrolment for a Phase I clinical trial of MPV/S-2P, an investigational nasal vaccine designed to provide broader protection against evolving variants of SARS-CoV-2.

A total of 60 subjects aged between 18 and 64 years will be enrolled at Baylor College of Medicine in Texas, the Hope Clinic of Emory University in Georgia and New York University in New York.

Each of these subjects will have received three or more doses of mRNA Covid-19 vaccines that have been approved or authorised by the US Food and Drug Administration (FDA).

The participants will be grouped into three cohorts to receive one dose of the nasal spray vaccine at varying dosages.

Researchers will conduct seven follow-up visits over 12 months to evaluate the vaccine’s tolerability and its ability to elicit immune responses in both the blood and the nasal passage.

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NIH National Institute of Allergy and Infectious Diseases director Jeanne Marrazzo said: “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.

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“While first-generation Covid-19 vaccines continue to be effective at preventing severe illness, hospitalisations, 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.”

MPV/S-2P makes use of the murine pneumonia virus (MPV) to offer a stabilised form of the SARS-CoV-2 spike protein (S-2P) to the respiratory tract’s epithelial cells.

Pre-clinical studies on non-human primates demonstrated that MPV/S-2P was safe, well-tolerated and induced strong systemic immune responses, including SARS-CoV-2-specific antibodies, as well as localised mucosal immunity.