A trial has begun of a new needle-free Covid-19 vaccine to protect against future variants of the virus. The jab uses a jet of air that pushes the vaccine into the skin, which could prove an alternative to those who have a fear of needles and used as a COVID-19 booster shot.
The University of Southampton said in a statement “If successful it could be scaled up and manufactured as a powder to boost global vaccination efforts, particularly in low- and middle-income countries.”
The NIHR Southampton Clinical Research Facility (CRF) is delivering the first trial of the vaccine candidate, DIOS-CoVax. The trial team are calling for healthy volunteers aged between 18 and 50 in the Southampton area. Participants must have had both doses of a COVID-19 vaccine but not their third dose booster. The first participant was given the vaccine in the CRF facility at University Hospital Southampton on Tuesday 14 December.
Saul Faust Clinical Chief Investigator and Director of the NIHR Southampton CRF and Professor of Paediatric Immunity and Infectious Diseases at the University of Southampton, said: “This isn’t simply ‘yet another’ coronavirus vaccine as it has both COVID-19 variants and future coronaviruses in its sights. This technology could give wide-ranging protection to huge numbers of people worldwide. “The people of Southampton and Hampshire have stepped up time and again to help find the vaccines that have unlocked the pandemic. We’re asking for their help again in developing this potentially game-changing vaccine.”
The vaccine has been developed by Professor Jonathan Heeney at the University of Cambridge and the spin-out company DIOSynVax, with funding from Innovate UK, part of UK Research and Innovation. Professor Heeney said: “The response of the scientific and medical communities to the development and delivery of COVID-19 vaccines has been incredible, but as new variants emerge and immunity begins to wane we need newer technologies. It’s vital that we continue to develop new generation vaccine candidates ready to help keep us safe from the next virus threats. “Our vaccine is innovative, both in terms of the way it primes the immune system to respond with a broader protective response to coronaviruses, and how it is delivered. Crucially, it is the first step towards a universal coronavirus vaccine we are developing, protecting us not just from COVID-19 variants but from future coronaviruses.” SARS-CoV-2 uses ‘spike’ proteins on its surface to gain entry to host cells. These proteins bind to ACE2, a protein receptor on the surface of cells in our airways, allowing the virus to release its genetic material into the host cell. The virus hijacks the host cell’s machinery to allow itself to replicate and spread.
Vaccines are a safe, natural way to inform our bodies about what dangerous infections look like and how to respond to them. This is much safer than becoming infected with the live virus, because it avoids the life-threatening effects the whole virus can have. Immunisation arms our immune system to look out for and block virus, or destroy cells that carry the spike protein, protecting us from COVID-19 disease. Unfortunately, SARS-CoV-2 is constantly mutating and the virus spike protein itself is changing. This raises the prospect of ‘vaccine escape’, where changes to the spike protein changes mean the immune system is no longer able to recognise it.
To get around this problem, the Cambridge team searched for new types of antigens – key regions of the virus – that are the same across coronaviruses that occur in nature, including animals that carry them such as bats.
While most COVID-19 vaccines use the sequence of the RNA for the virus Spike protein from the first isolated samples of the COVID-19 virus in January 2020, this new DIOSvax technology uses predictive methods to encode antigens like the Spike protein that mimic the wider family of coronavirus antigens, thus giving wider protection. The body’s immune cells take up the vector, decode the DIOS-vaccine antigen and present the information to the immune system. This in turn produces neutralising antibodies, which block virus infection, and T-cells, which remove virus-infected cells. This technology is well-established and the vaccine plasmid DNA does not get taken up into human genetic material.
The vaccine can be delivered pain-free without a needle into the skin, using the PharmaJet Tropis® intradermal Needle-free Injection System. This delivers the vaccine in less than a tenth of a second by spring-powered jet injection. The phase I vaccine trial in Southampton will follow up volunteers for approximately 12 months to ensure it is safe. Payment of up to £785 will be provided for time and inconvenience across 11 visits.
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As well as being useful for people with a fear of needles, the vaccine can be freeze-dried, making it easier to store. Participants began taking part in the trial at the NIHR Southampton Clinical Research Facility on Tuesday. Demonstrating the vaccine earlier this year, Dr Rebecca Kinsley from DIOSynVax said: "There's no needle or hole. It uses a high-powered jet stream, which allows the vaccine to pass through the layer of skin."