Following positive results from preclinical testing at the University of Alabama at Birmingham last year, the Altimmune Inc. COVID-19 vaccine candidate AdCOVID is set to start a phase one clinical trial this week.
Efforts will begin with patient enrollment, now that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug application. Up to 180 healthy volunteers between the ages of 18 and 55 will be selected to test the safety and immunogenicity of AdCOVID. It will be administered to them via nasal spray at one of three dose levels, after which researchers will assess safety, tolerability, and immunogenicity.
“We believe deployment of intranasal vaccines like AdCOVID will be essential to a successful global response to the pandemic,” Altimmune President and CEO Vipin Garg said. “Developing vaccines that can effectively prevent transmission is a growing imperative to block the spread of disease and combat the emergence of new variants.”
If successful, the vaccine offers some major potential advantages: no refrigeration necessary, protection potential against both infection and transmission, and simple dispersal. In fact, it would be the only intramuscular COVID-19 vaccine to create such multi-level immunity thus far.
In preclinical testing last year, AdCOVID promoted immune responses to SARS-CoV-2 in the nose and lungs of animals after a single dose. It stirred antibody responses, T cell responses, and prominent mucosal immunity mice. The leading researcher of those tests, Dr. Fran Lund, noted that if the vaccine works similarly in humans, it could protect the vaccinated and help minimize transmission among the rest of the population.