November 25, 2020 -- Altimmune has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to begin a phase I clinical trial of its single-dose intranasal COVID-19 vaccine, AdCOVID.
AdCOVID is designed to stimulate broad immune responses including neutralizing antibodies and T-cell responses in the nasal cavity and respiratory tract. Preclinical studies of the vaccine were conducted at the University of Alabama at Birmingham. The phase I safety and immunogenicity study is planned to begin by the end of the year and interim data is expected in the first quarter of 2021.
AdCOVID is expected to have extended stability at room temperature allowing for cold chain-free shipment of the vaccine, where it can then be stored in common refrigerators. Due to the nature of intranasal administration, the vaccine is particularly well-suited for use in children, according to the company. The phase I study will include evaluation of the vaccine in children as young as 2 years of age.