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COVID-19 VACCINE CANDIDATE BEGINS FIRST CLINICAL STUDY

A COVID-19 vaccine candidate that underwent extensive preclinical testing at UAB in the spring and summer was scheduled to begin clinical testing in December. Biopharmaceutical company Altimmune Inc., submitted an Investigational New Drug, or IND, application to the FDA to commence a Phase 1 clinical study of its single-dose intranasal COVID-19 vaccine candidate, AdCOVID.

The UAB preclinical study for Altimmune showed that AdCOVID stimulated a broad immune response, including both systemic immunity—as shown by neutralizing antibodies in the blood—as well as local immunity, featuring mucosal IgA and resident memory T-cells in the nasal cavity and respiratory tract.

Intranasal vaccination is an attractive strategy for COVID-19, as the nasal mucosa represents the first-line barrier to SARSCoV-2 entry before viral spread to the lung. “It’s not widely known or appreciated that nasal mucosal immunity may be essential in preventing the spread of the SARS-CoV-2 virus to other individuals by stopping replication and transmission of the virus at the site of infection — the nose and respiratory tract,” says Fran Lund, Ph.D., leader of the UAB preclinical work, and the Charles H. McCauley Professor and Chair for the UAB Department of Microbiology. “Several recent studies have shown that, in the absence of mucosal immunity, the nasal cavity may become a reservoir for the coronavirus, particularly in children, potentially allowing for disease transmission even after an intramuscular vaccination.”

“A vaccine that prevents transmission by children would allow them to return to school and their parents to return to work,” Lund says. “We are excited to collaborate with Altimmune on the advancement of this important next-generation vaccine and look forward to seeing data from the upcoming clinical study.”

Vipin Garg, Ph.D., president and chief executive officer of Altimmune, says, “We’ve made exceptional progress advancing AdCOVID and are on track to begin a Phase 1 clinical study this year, with a data readout anticipated in the first quarter of 2021. While the progress being reported with current vaccines is very encouraging, many in the scientific and medical communities agree that there is continued need for next-generation vaccines that offer significant enhancements.”

Last spring and summer, 24 researchers from six labs at UAB—all working under UAB COVID-19 safety protocols—and eight researchers at Altimmune tested the potential COVID-19 vaccine in a collaboration that was announced March 30. “The goal,” Lund said at the time, “is to get the data to Altimmune as rapidly as possible, so they will use the information gained from the preclinical study to design their clinical trial in people.” – Jeff Hansen

Dr. Lund on NPRScientists Race To Develop Next Generation Of COVID Vaccines

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Dr. Lund on the Octavian Report Podcast – What do Intranasal Vaccines Mean for COVID?

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Dr. Lund on NPRWhat A Nasal Spray Vaccine Against COVID-19 Might Do Even Better Than A Shot

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Dr. Lund on NPRQ&A: What’s Different About The Delta Variant

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