LONDON – Trials have begun in London for the next generation of COVID-19 vaccines, with the first dose for a new nasal vaccine developed by the American company Codagenix administered in a quarantine facility in London, announced on Monday morning .
“This vaccine is one of the first of the next generation of 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 conducting the trials, said in a statement.
To reach the finish line, the vaccine must prove to be safe and effective in three step-by-step experimental ‘phases’ – a process that can take many months.
But this vaccine, called COVI-VAC, differs from the current vaccines that are commercially available. It uses an ‘attenuated form of the naturally occurring virus that will not cause disease but will generate a strong immune response’, explains Robert Coleman, CEO of Codagenix, PHD. “Historically, live attenuated vaccines have been very effective, providing long-lasting and broad immunity and usually relying on a single dose.”
Meanwhile, Coleman said: “current mRNA, VLP and adenovirus-based vaccines are targeted only at the Spike protein, which limits the variety of antibodies that can be produced.”
And as Sybil Tasker, Managing Director, MPH, Chief Medical Officer of Codagenix notes, COVI-VAC may be more effective at combating mutant strains of the virus that may occur in the future: “If a live attenuated vaccine has COVI-VAC the potential to elicit a broader immune response compared to other COVID-19 vaccines targeting only a portion of the virus, which may be critical as new variants of SARS-CoV-2 begin to appear. ”
COVI-VAC was developed using an algorithm that essentially recodes viral genes, Coleman explains, “to cause slow, inefficient translation of viral genes into the human cell in a process that Codagenix calls ‘de-optimization.’
‘We enter the sequence of the target virus into our algorithm and the software optimizes the viral gene digitally. We then synthesize the corresponding DNA and exchange or stitch it into the genome of the natural virus. In this process, the natural virus is essentially converted from enemy to friend, making it harmless but can elicit a broad immune response. ‘
The use of a live attenuated virus in a vaccine is nothing new. ‘Most of the vaccines we get as children are called live-attenuated vaccines. That is, they can cause an infection but do it so poorly that there is no danger of the infection, but immunity is generated in the same way as for the normal virus, ” said Ian Jones, professor of virology at the Reading University, said.
‘The biggest problem with this approach is that the weakening of the weakening has historically been very time consuming and demanding. This new approach makes the weakened tension in one step. ”
Because the Codagenix vaccine uses an attenuated form of live virus, there is a good chance that volunteers could transmit the virus to the community or even suffer from some disease. To reduce these potential risks, the trials are being conducted in a secure quarantine facility in East London.
“This is an extra measure of caution,” Andrew Catchpole, the chief scientific officer responsible for the trials, told ABC News, “There is no regulatory requirement that the vaccine be tested at a quarantine facility. . ‘
Catchpole is the head of the scientific officer of hVIVO and is also expected to head the team that will conduct the first human challenge trials for a COVID-19 vaccine.
“Codagenix has sought a clinic with experience with vaccines and live viruses, and a laboratory for the first human evaluation of COVI-VAC to enable thorough evaluation of product safety and real-time monitoring of volunteers,” Coleman said.
The first small group of young healthy adult volunteers get the dose by dropping it in their nose, and they will then be closely monitored and tested regularly. The trial will follow a standard dose escalation method.
“The first phase of this study is expected to provide evidence to substantiate this expectation of a short duration of virus shedding, showing that the vaccine virus is indeed strongly attenuated and does not cause disease,” Catchpole told ABC News.
Unlike the approved vaccines, Codagenix believes that the vaccine can provide long-term immunity to COVID-19, with only one or two doses needed over a lifetime, similar to the vaccine against MMR or chickenpox.
‘Most live attenuated vaccines are by design unable to fully replicate viruses. This vaccine is different. To be able to do this, it maximizes the immune response and becomes as natural as possible against immune protection as if the person was exposed to the real virus, ”Catchpole added.
But it is still early days, with the hurdles of even more phases of clinical trials ahead, ‘this study will facilitate the vaccine to then conduct clinical trials on phase 2 efficacy and immunogenicity testing’, Catchpole explains.
Nevertheless, Codagenix is full of confidence and has been working at the ‘lightning speed’ to get to this stage and has teamed up with the largest vaccine producer in the world, the Serum Institute of India.
‘Once it became clear that the SARS-CoV-2 outbreak would 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 meeting the unmet need to protect against COVID-19, especially in low-income countries around the world. ”
Coleman hopes the simplicity with which this vaccine can be given – to inject it into someone’s nose – matches the ease with which it can be manufactured and transported will make it a key player in the world’s fight against COVID-19.
But Jones warns that there is still a long way to go, “they are far behind the current vaccines, so whether it will come fast enough to make a contribution is not clear.”