Phase 1 Trial for Intranasal, Single-Dose COVID-19 Vaccine Candidate Begins Enrollment

Altimmune, Inc. has begun enrollment for its phase 1 clinical trial of a single-dose, intranasal COVID-19 vaccine candidate (AdCOVID), which could reduce logistical challenges for COVID-19 vaccine administration.

The vaccine candidate is an adenovirus-vector vaccine designed to stimulate a broad immune response including both systemic immunity and local immunity in the nasal cavity and respiratory tract. The trial will evaluate the safety and immunogenicity of the vaccine candidate in up to 180 healthy adult volunteers between the ages of 18 and 55 years.

“While the roll out of currently available vaccines is an important first step in our efforts to slow the pandemic, there remains a critical need for vaccines that provide mucosal immunity,” said Scot Roberts, PhD, Chief Scientific Officer of Altimmune, in a prepared statement. “As pioneers in intranasal vaccine development, we believe AdCOVID has the potential for many advantages over currently available vaccines, including, intranasal dosing and ease of distribution and storage, if the product is shown to have extended stability at room temperature, in addition to the potential ability to block transmission of the virus.”

According to Altimmune, the trial participants will receive AdCOVID at 1 of 3 dose levels administered as a nasal spray. In addition to the primary study endpoint of safety and tolerability, the immunogenicity will be evaluated by serum IgG binding and neutralizing antibody titers, mucosal IgA antibody from nasal samples, and T cell responses.

The company anticipates having a full data readout from the phase 1 study in the second quarter of 2021.

According to Altimmune, vaccines delivered via intramuscular injection have not been shown to induce mucosal immunity in the nasal cavity, which may be effective in blocking transmission of SARS-CoV-2. AdCOVID is designed to deliver the vaccine directly to the site of viral entry and replication in order to stimulate mucosal and cellular immunity in the nasal cavity and respiratory tract, which could potentially be a first line of defense against the virus.

Dr. Scott Harris, chief medical officer, Altimmune, said that the commencement of the phase 1 clinical trial for AdCOVID is an important milestone for the global health care community in the fight against the SARS-CoV-2 virus that causes COVID-19.

“As the rise of new variants of the SARS-CoV-2 virus is particularly troubling, to stop mutations of the virus we must stop replication and transmission, and we believe AdCOVID could play an essential role in this endeavor,” said Harris, in a prepared statement.

REFERENCE

Altimmune Commences Enrollment in Phase 1 Clinical Trial of AdCOVID—a Needle-Free, Single-Dose Intranasal COVID-19 Vaccine Candidate [news release]. Gaithersburg, MD; February 25, 2021: Altimmune. Accessed February 25, 2021. https://www.globenewswire.com/news-release/2021/02/25/2182311/0/en/Altimmune-Commences-Enrollment-in-Phase-1-Clinical-Trial-of-AdCOVID-a-Needle-Free-Single-Dose-Intranasal-COVID-19-Vaccine-Candidate.html