The Phase I trial, which will enrol 30 healthy volunteers aged 18–40, will investigate the level of immune system responses generated by the vaccine using this delivery technique, as well as monitoring safety and for any adverse reactions.
All of the volunteers will receive the same vaccine that is currently being delivered by intramuscular injection as part of the national roll out of the ChAdOx1 nCoV-19 vaccine. The volunteers, who will be drawn from the local Oxford region, will be followed for a total of four months.
Dr Sandy Douglas, Clinician-Scientist and Chief Investigator of the study said:
'Some immunologists believe that delivering the vaccine to the site of infection may achieve enhanced protection, especially against transmission, and mild disease. We hope this small safety-focused study will lay the foundation for future larger studies that are needed to test whether giving the vaccine this way does protect against coronavirus infection.'
The vaccine will be delivered using an intranasal spray device, similar to many over-the-counter hay fever nasal sprays.
Dr Douglas adds:
'There are a variety of people who will find an intranasal delivery system more appealing, which may mean vaccine uptake is higher in those groups. It might also have practical advantages – nasal sprays have been used successfully for other vaccines, for example the flu vaccine used in UK schools.'
Dr Meera Madhavan, Lead Clinical Research Fellow, Jenner Institute said:
'This study will help us to understand the safety of, and side-effects associated with, giving the Oxford/ AstraZeneca COVID-19 vaccine by nasal spray. It is an important first step towards increasing our range of options for curtailing the spread and impact of COVID-19 globally.'
Professor Adrian Hill, Director the Jenner Institute and Principal Investigator of the study said:
'This is an exciting new approach to administering a leading COVID-19 vaccine that could be very effective in preventing not just disease episodes but also asymptomatic infections, and thereby help reduce transmission in the population.'
For further information on the trial, including how to participate, visit: www.jenner.ac.uk/volunteer/recruiting-trials/covid-19-vaccine-intranasal-study-cov008