University of Pittsburgh School of Medicine researcher scientists have a potential vaccine targeting SARS-CoV-2. Pre-clinical research on mice reveal that the fingerprint-sized patch produces antibodies specific to the novel coronavirus at quantities thought to be sufficient for neutralizing the virus. Recently, when tested in mice, the experimental product known as PittCoVacc generated a surge of antibodies against SARS-CoV-2 within two weeks of the microneedle pick.
The University of Pittsburgh team was previously involved in vaccine research for SARS-CoV in 2003 and MERS-CoV 2014. Both closely related to SARS-CoV-2, involve the spike protein which researchers have learned is important when considering inducement of immunity against the virus.
Published recently in eBioMedicine (The Lancet), the University of Pittsburgh based researchers subjected the underlying product to significant external peer review, they highlight to the experimental mRNA vaccine candidate now in clinical trials (mRNA-1273 from Moderna) noting that PittCoVacc (short for Pittsburgh Coronavirus Vaccine) follows a more established approach—for example, using lab-made pieces of viral protein to construct immunity. Much like the current flu short works.
The team designed the vaccine to build on the original scratch method used to deliver the smallpox vaccine to the skin but in a more high-tech way that is more efficient and reproducible patient to patient. The researchers also used a novel approach to deliver the drug, called a microneedle array, to increase potency. This array is a fingertip-sized patch of 400 tiny needles that delivers the spike protein pieces into the skin, where the immune reaction is strongest. The patch goes on like a Band-Aid and then the needles—which are made entirely of sugar and the protein pieces—simply dissolve into the skin.
As reported, the experimental vaccine has worked on mice. However, the animals haven’t been monitored long term as of yet but the investigators can show presently that those mice who received the MERS-CoV vaccine produced a sufficient level of antibodies to neutralize the virus for at least a year and thus far the antibody levels of the SARS-CoV-2 vaccinated animals are following a similar positive trend. The researchers noted in their press release that the SARS-CoV-2 microneedle vaccine maintains its potency despite sterilization with gamma radiation—a key step toward producing a suitable product for human intervention.
The team reports the vaccine system is scalable—the protein pieces are manufactured by a “cell factory”—that is layers upon layers of cultured cells engineered to express the SARS-CoV-2 spike protein—that can be stacked further to multiply yield. Moreover, they report that the protein can be purified at industrial scale. Mass producing the microneedle array involves spinning down the protein-sugar mixture into a mold using a centrifuge. Once produced, the vaccine can then sit at room temperature until its needed. This removes the need for refrigeration during transport or storage.
How have the Pulled it off Thus Far
First and foremost, co-senior author Andrea Gambotto can’t convey enough the importance of funding, noting, “That’s why it’s important to fund vaccine research. You never know where the next pandemic will come from.” She continued, “Our ability to rapidly develop this vaccine was a result of scientists with expertise in diverse areas of research working together with a common goal,” reported Louis Falo, professor and chair of dermatology at Pitt’s School of Medicine and UPMC.
This study was publicly funded via the National Institute of Allergy and Infectious Diseases; National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Cancer Institute.
Andrea Gambotto, associate professor of surgery, Pitt School of Medicine
Louis Falo, professor and chair of dermatology, Pitt School of Medicine and UPMC
Note, an entire team was involved as well and the source University of Pittsburgh news lists all members.
Call to Action: The University of Pittsburgh investigators are now in the process of applying for an investigational new drug (IND) approval from the U.S. Food and Drug Administration (FDA) in anticipation of starting a Phase I human clinical trial within a few months. TrialSite News monitors this research group and will update the readers via the daily newsletter.