COVID-19 Vaccine Candidate Shows Promise in First Peer-Reviewed Research

COVID-19 Vaccine Candidate Shows Promise from University of Pittsburgh on Vimeo. https://vimeo.com/403428170
The system is also highly scalable. The protein pieces are manufactured by a “cell factory”—layers upon layers of cultured cells engineered to express the SARS-CoV-2 spike protein—that can be stacked further to multiply yield. Purifying the protein can also be done at industrial scale. Mass-producing the microneedle array involves spinning down the protein-sugar mixture into a mold using a centrifuge. Once manufactured, the vaccine can sit at room temperature until it’s needed, eliminating the need for refrigeration during transport or storage.

“For most vaccines, you don’t need to address scalability to begin with,” Gambotto said. “But when you try to develop a vaccine quickly against a pandemic that’s the first requirement.”

Credit: Felipe Esquivel Reed / Wikimedia Commons

When tested in mice, PittCoVacc generated a surge of antibodies against SARS-CoV-2 within two weeks of the microneedle prick.

Those animals haven’t been tracked long term yet, but the researchers point out that mice who got their MERS-CoV vaccine produced a sufficient level of antibodies to neutralize the virus for at least a year, and so far the antibody levels of the SARS-CoV-2 vaccinated animals seem to be following the same trend.

Importantly, the SARS-CoV-2 microneedle vaccine maintains its potency even after being thoroughly sterilized with gamma radiation—a key step toward making a product that’s suitable for use in humans.

The authors are now in the process of applying for an investigational new drug (IND) approval from the Food and Drug Administration in anticipation of starting a phase I human clinical trial in the next few months.

“Testing in patients would typically require at least a year and probably longer,” Falo said. “This particular situation is different from anything we’ve ever seen, so we don’t know how long the clinical development process will take. Recently announced revisions to the normal processes suggest we may be able to advance this faster.”

Additional authors on the study are Eun Kim, Geza Erdos, Shaohua Huang, Thomas Kenniston, Stephen Balmert, Cara Donahue Carey, Michael Epperly, William Klimstra and Emrullah Korkmaz, all of Pitt; and Bart Haagmans, of Erasmus Medical Center.

Funding for this study was provided by National Institute of Allergy and Infectious Diseases grant R21-AI114264, National Institute of Arthritis and Musculoskeletal and Skin Diseases grants R01-AR074285, R01-AR071277 and R01-AR068249, and National Cancer Institute grant T32-CA175294.