University of Alabama at Birmingham’s Preclinical Study of COVID-19 Vaccine Candidate Helps Lead to FDA Greenlight of IND

University of Alabama at Birmingham’s Preclinical Study of COVID-19 Vaccine Candidate Helps Lead to FDA Greenlight of IND TrialsiteN

While Maryland biotech firm Altimmune Inc recently announced that its COVID-19 vaccine candidate, known as AdCOVID, was headed to Phase 1 clinical trials (FDA cleared the firm’s Investigational New Drug Application), the novel, single-dose intranasal vaccine candidate was actually tested during preclinical studies at the University of Alabama at Birmingham. Led by Fran Lund last spring through the summer, the UAB preclinical testing of AdCOVID included 23 other researchers from six UAB labs in the UAB School of Medicine. All UAB preclinical work was done under strict COVID-19 safety protocols (e.g. requiring masks and social distancing). Contributing to the ultimate FDA greenlight of the IND, the UAB research team discovered potent serum neutralizing antibody responses, T cell responses, and robust induction in mucosal immunity in mice after a single intranasal dose of the novel candidate, reports Jeff Hansen with UAB News.

Recently announcing FDA clearance to proceed in a Phase 1 clincial trial, Altimmune’s vaccine candidate reveals significant promise. With no need for cold storage and a simple, one -dose administration via a nasal spray.  Apparently this novel candidate elicits mucosal immunity at the nose but also the lungs, and serves to protect against both infection but also importantly against transmission. According to Jeff Hansen’s recent UAB News piece, existing intramuscular COVID-19 vaccines don’t elicit this kind of immunity.

Phase 1 Clinical Trial

The Phase 1 clinical trial will look into the safety and immunogenicity of the novel vaccine in up to 180 healthy volunteers ranging in age from 18 to 55. Investigating one of three dose levels, the sponsor (Altimmune) investigates mostly safety but also tolerability as well as immunogenicity of the vaccine by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody samples from the nose and actual T cell responses.

Dr. Lund

Dr. Fran Lund holds the Charles H. McCauley Chair of Microbiology  and joined UAB just over a decade ago.