Authors: Heather Jones, Future Science Group
Researchers from the University of Pittsburgh (PA, USA) have revealed the results of a preclinical trial testing their COVID-19 vaccine candidate in mice. The study, published by The Lancet, suggests that this vaccine has the potential to sufficiently neutralize the virus, and could pave the way to human trials beginning within the next few months.
As the coronavirus continues to spread across the globe, the search for a successful vaccine intensifies. Fortunately, researchers from the University of Pittsburgh have been able to act quickly after laying the groundwork during previous coronavirus epidemics.
“We had previous experience on SARS-CoV in 2003 and MERS-CoV in 2014. These two viruses, which are closely related to SARS-CoV-2, teach us that a particular protein, called a spike protein, is important for inducing immunity against the virus. We knew exactly where to fight this new virus,” commented Andrea Gambotto (Pitt School of Medicine, PA, USA)). “You never know where the next pandemic will come from.”
This vaccine candidate, termed PittCoVacc, was developed using lab-made pieces of viral protein to build immunity, the same way the current flu shots work.
In efforts to increase potency, the researchers used a novel approach to deliver the drug termed a microneedle array. This involves a fingertip-sized patch of 400 tiny needles that dissolve to deliver the spike protein pieces into the skin, where the immune reaction is strongest.
“We developed this to build on the original scratch method used to deliver the smallpox vaccine to the skin, but as a high-tech version that is more efficient and reproducible patient to patient,” commented Louis Falo (Pitt School of Medicine).
The system is also highly scalable, as the protein pieces and microneedle can be manufactured rapidly and purified on an industrial scale. Once manufactured, the vaccine can sit at room temperature,
“For most vaccines, you don’t need to address scalability to begin with,” Gambotto noted. “But when you try to develop a vaccine quickly against a pandemic that’s the first requirement.”
When testing PittCoVacc in mice, the team observed a surge of antibodies generated against SARS-CoV-2 within 2 weeks of the microneedle prick.
While recognizing that the mice will need to be tracked long term, the researchers noted that in previous similar vaccine trials, mice produced a sufficient level of antibodies to neutralize the virus for at least a year.
The team hope to receive approval from the US Food and Drug Administration to commence a Phase I human clinical trial in the next few months.
“Testing in patients would typically require at least a year and probably longer,” commented Falo. “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.”
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