STELLAR
Research type
Research Study
Full title
In-depth analysis of the nasal mucosal and systemic immune response in children given a live-attenuated intra-nasal influenza vaccine
IRAS ID
340764
Contact name
Dominic Kelly
Contact email
Sponsor organisation
Research Governance, Ethics & Assurance Team (RGEA), University of Oxford
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
This research study aims to understand how the body’s defence system within the nose responds to the nasal flu vaccine in children. Nasal vaccines can induce a protective response (also called an immune response) within the nose that is highly protective against infections. The ways by which an immune response in the nose is produced after nasal vaccination are not fully understood. A better understanding of how this works will allow the development of better tests, treatments, and vaccines for children in the future.
To understand how these protective responses are generated, we will vaccinate up to 40 children, aged 2-5 years old, with a live-attenuated influenza vaccine (LAIV). ‘Live-attenuated’ means that the vaccine contains a living virus that has been weakened so it cannot cause healthy people to become unwell. This vaccine is routinely used in the UK to vaccinate children against influenza. We will be providing the children with the same vaccine that they are due to receive. We will collect cells and fluid from the nose and saliva. These samples will be analysed to understand how the cells change and communicate over time, in response to the virus in the vaccine. We will compare the results from the nose and saliva samples with blood samples. This may lead to us identifying blood indicators (“biomarkers”) that could provide reliable information about the immune response within the nose. We may also discover “biomarkers” in the nose that tells us a protective immune response is occurring there. This may lead researchers to know what to look for and how to look for it, leading to the development of better vaccines. We will compare our results with other related projects and learn even more about how children's immunity compares to adults. This is a very low risk study as the children are being given a safe, licenced vaccine that they should be getting every year anyway. The methods we use to take our samples are also very safe and minimally invasive and standard blood taking procedures by well-trained medical staff.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0251
Date of REC Opinion
12 Aug 2024
REC opinion
Further Information Favourable Opinion