On Feb. 17, 2021, Altimmune announced that the U.S. Food and Drug Administration (FDA) had cleared the Companyls Investigational New Drug (IND) application for its Phase 1 clinical trial of AdCOVID, a novel, single-dose, intranasal COVID-19 vaccine candidate. Altimmune expected to commence patient enrollment in the Phase 1 clinical trial in the following week.

The Phase 1 clinical trial will evaluate the safety and immunogenicity of AdCOVID in up to 180 healthy adult volunteers between the ages of 18 and 55. Volunteers will receive AdCOVID at one of three dose levels administered as a nasal spray. In addition to the primary study endpoint of safety and tolerability, the immunogenicity of AdCOVID will be evaluated by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples, and T cell responses.

AdCOVID is a single-dose intranasal vaccine candidate for COVID-19. It is designed to stimulate a broad immune response including both systemic immunity (neutralizing antibody) and local immunity (mucosal IgA, resident memory T cells) in the nasal cavity and respiratory tract.