BIRMINGHAM, Ala. (WBRC) - A big update in the COVID-19 vaccine testing at the University of Alabama at Birmingham. The Altimmune Inc. vaccine candidate that was tested at UAB in 2020 is expected to start patient enrollment for its Phase 1 clinical trial next week.
Altimmune announced the United States Food and Drug Administration has cleared the company’s Investigational New Drug application for its Phase 1 clinical trial of AdCOVID.
That vaccine is a novel, single-dose, intranasal COVID-19 vaccine candidate.
The UAB preclinical testing of AdCOVID last spring and summer was led by Fran Lund, Ph.D., chair of the UAB Department of Microbiology, and it included 23 other researchers from six UAB labs in the UAB School of Medicine.
Researchers said they had several positive findings after giving the doses to mice.
Besides being intranasal, the vaccine does not have to be refrigerated. It’s a simple one-dose administration by a spray into the nose.
Altimmune says it expects that these simple and convenient handling requirements, together with the potential ability to block SARS-CoV-2 transmission, could position AdCOVID as a leading intranasal COVID-19 vaccine.
“We believe deployment of intranasal vaccines like AdCOVID will be essential to a successful global response to the pandemic,” said Vipin K. Garg, Ph.D., president and chief executive officer of Altimmune. “Developing vaccines that can effectively prevent transmission is a growing imperative to block the spread of disease and combat the emergence of new variants.”
Fran Lund, Ph.D. said Altimmune’s Phase 1 clinical trial will evaluate AdCOVID in up to 180 healthy volunteers between the ages of 18 and 55. AdCOVID will be administered as a nasal spray at one of three dose levels. Altimmune will look primarily for safety and tolerability.
Lund said of last year’s preclinical testing, “In animals, intranasal vaccination initiated immune responses to the SARS-CoV-2 virus in the nose and lungs, which are the sites that are first infected by the virus.
“If the vaccine works similarly in humans, then we hope that vaccination via the intranasal route might not only protect the vaccinated person from serious illness but also help minimize virus transmission within the community. We look forward to seeing the first data from the human studies.”