By ZOE MAGEE, ABC News
(LONDON) — Trials have begun in London for the next generation of COVID-19 vaccines with the first dose for a new nasal vaccine being developed by the U.S. company Codagenix having been administered at a quarantine facility in London, it was announced Monday morning.
“This vaccine is one of the first of the next generation COVID-19 vaccines, it is a single dose, needle free, intranasal, live attenuated COVID-19 virus vaccine.” Cathal Friel, Executive Chairman, of Open Orphan, the company running the trials said in a statement.
To make it to the finish line, the vaccine will need to prove it’s safe and effective in three stepwise experimental ‘phases’ — a process that could take many months.
But this vaccine, called COVI-VAC, is different from current commercially available vaccines. It uses a “weakened form of the naturally occurring virus that will not cause disease but will generate a strong immune response,” explains Codagenix CEO Robert Coleman, PHD. “Historically, live attenuated vaccines have been very effective, providing long-lasting and broad immunity and typically relying on a single dose.”
Meanwhile, Coleman said, “the current mRNA, VLP, and adenovirus-based vaccines target only the Spike protein, limiting the range of antibodies that can be produced.”
And as Sybil Tasker, MD, MPH, Chief Medical Officer of Codagenix notes, COVI-VAC could be more effective at fighting mutant strains of the virus that may emerge in the future, “As a live attenuated vaccine, COVI-VAC has the potential to provide a broader immune response in comparison to other COVID-19 vaccines that target only a portion of the virus, which could prove critical as new variants of SARS-CoV-2 have begun to emerge.”
COVI-VAC was developed using an algorithm which essentially recodes viral genes, Coleman explains, “to cause slow, inefficient translation of viral genes in the human cell in a process Codagenix refers to as “de-optimization.”
“We input the sequence of the target virus into our algorithm and the software digitally deoptimizes the viral gene. We then synthesize the corresponding DNA and swap or stitch it into the natural virus’s genome. This process essentially converts the natural virus from foe to friend — rendering it harmless but able to engender a broad immune response.”
Using a live attenuated virus in a vaccine is nothing new, “Most of the vaccines we get as children are so called live-attenuated vaccines. That is, they can cause an infection but do so so weakly that there is no danger from the infection, but immunity is generated in the same way as for the normal virus,” Ian Jones, Professor of Virology at Reading University said.
“The main problem with this approach is that, historically, making the weakened strain took a lot of trial and error. This new approach makes the weakened strain in one step.”
As the Codagenix vaccine uses a weakened form of live virus there is a small chance that volunteers could transmit the virus in the community or even suffer from some disease. To mitigate these potential risks, the trials are being conducted in a secure quarantine facility in East London.
“It is an added extra level of caution,” Andrew Catchpole the Chief Scientific Officer in charge of the trials told ABC News, adding that, ”There is no regulatory requirement for the vaccine to be tested at a quarantine facility.”
Catchpole is hVIVO’s Chief Scientific officer, and is also expected to head the team which will conduct the first human challenge trials for a COVID-19 vaccine.
“Codagenix sought an inpatient facility with experience with vaccines and live viruses, and an onsite laboratory for the first-in-human evaluation of COVI-VAC to allow for thorough evaluation of product safety and real-time volunteer monitoring,” Coleman said.
The first small group of young healthy adult volunteers will be given the dose by dropping it into their nose and they will then be closely monitored and regularly tested. The trial will follow a standard dose escalation methodology.
“The first phase of this study is expected to provide the evidence to back up this expectation of a short duration of virus shedding in addition to demonstrating that the vaccine virus is indeed highly weakened and does not cause disease,” Catchpole told ABC News.
Unlike the vaccines that have been authorized, Codagenix believes its vaccine could provide long-term immunity against COVID-19, with only one or two doses needed over a lifetime, similar to that of the MMR or chicken pox vaccines.
“Most live attenuated vaccines by design cannot fully replicate viruses, this vaccine is different in that it can. Being able to do this maximizes the immune response and gets as natural as possible immune protection just as if the person were exposed to the actual virus,” Catchpole added.
But it is still early days, with the hurdles of more phases of clinical trials ahead, “this study will facilitate the vaccine then moving into phase 2 efficacy and immunogenicity testing clinical studies” explains Catchpole.
Nonetheless Codagenix is confident and has worked at what it calls “lightning speed” to get to this stage and have teamed up with the world’s largest vaccine producer, the Serum Institute of India.
“As soon as it became clear that the SARS-CoV-2 outbreak was about to become a global problem, our scientists jumped into action to generate a live attenuated vaccine against COVID-19. Codagenix and our global partner, Serum Institute of India, are committed to serving the unmet need to protect against COVID-19, especially in lower income countries around the world.”
Coleman hopes that the simplicity with which this vaccine can be given — just be squirting it into someone’s nose — matched with the ease it can be produced and transported will make it a major player in the world’s fight against COVID-19.
But Jones warns that there’s a still a long way to go.
“They are far behind the current vaccines so whether they will get anywhere fast enough to make a contribution is not clear,” he said.
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