Altimmune Inc.’s AdCOVID vaccine candidate is set to begin its Phase 1 clinical trial this week, the company announced in recent days.
This vaccine candidate was tested preclinically on mice last spring and summer at the University of Alabama at Birmingham (UAB); it also potentially offers several advantages to the vaccines currently approved by the FDA for usage on humans.
First, AdCOVID is administered intranasally rather than intramuscularly; this means that instead of having to get a shot, the vaccine candidate would simply be offered through a painless nasal spray.
Additionally, it is a single-dose vaccine candidate, as opposed to the two-dose regimen of the Pfizer and AstraZeneca vaccines.
AdCOVID does not have to be stored in a refrigerator or freezer, representing a major advantage when it comes to transportation and distribution logistics.
The UAB preclinical testing of AdCOVID in 2020 was led by Fran Lund, Ph.D., chair of the UAB Department of Microbiology. The effort included 23 other researchers from six labs within the UAB School of Medicine. They found potent serum neutralizing antibody responses, T cell responses and a robust induction in mucosal immunity in mice following a single intranasal dose of AdCOVID.
The power to elicit mucosal immunity at the linings of the nose and lungs especially stands out, as this would protect not only against infection but also against transmission.
The company believes that its logistical superiorities, if clinical testing should prove it effective in humans, will position AdCOVID highly in the marketplace.
“We believe deployment of intranasal vaccines like AdCOVID will be essential to a successful global response to the pandemic,” stated Vipin K. Garg, Ph.D., president and CEO 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.”
Altimmune’s Phase 1 clinical trial will reportedly evaluate safety and immunogenicity of AdCOVID in up to 180 healthy volunteers between the ages of 18 and 55. The Company will look primarily for safety and tolerability, but it will also measure immunogenicity of AdCOVID by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples and T cell responses.
Lund commented 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,” she added. “We look forward to seeing the first data from the human studies.”
Altimmune had hoped to begin Phase 1 clinical testing in the fourth quarter of 2020, however the FDA did not immediately green light its Investigational New Drug application following a November submission.
Sean Ross is the editor of Yellowhammer News. You can follow him on Twitter @sean_yhn