According to Altimmune, the FDA has now cleared the company’s IND for a Phase 1 trial of its AdCOVID intranasal vaccine candidate, and enrollment in the trial is expected to begin within a week. Altimmune initially submitted the IND in November 2020, and the FDA placed a clinical hold on the application in December 2020 citing the need for changes to the protocols and more CMC data. The trial is expected to enroll up to 180 healthy volunteers aged 18-55 who will each receive one of three dose levels of AdCOVID.
The company is developing AsCOVID in partnership with the University of Alabama Birmingham and has signed an agreement with Lonza for manufacturing of the vaccine. Altimmune’s pipeline includes two other intranasal vaccines, NasoShield for anthrax and NasoVAX for flu.
Altimmune President and CEO Vipin K. Garg commented, “We believe deployment of intranasal vaccines like AdCOVID will be essential to a successful global response to the pandemic. FDA clearance of the IND marks an important step in developing a safe and effective vaccine designed to stimulate mucosal as well as systemic immunity following intranasal administration. Developing vaccines that can effectively prevent transmission is a growing imperative to block the spread of disease and combat the emergence of new variants. We look forward to the data from this trial in the coming weeks.”
Read the Altimmune press release.
