ECLIPSE
Research type
Research Study
Full title
Human co-Infection challenge study of S. pneumoniae (Spn) and Live Attenuated Influenza Vaccine (LAIV) in older healthy adults
IRAS ID
343692
Contact name
Katrina Pollock
Contact email
Sponsor organisation
Research Governance, Ethics & Assurance Team (RGEA), University of Oxford
Duration of Study in the UK
3 years, 4 months, 31 days
Research summary
In our study, we aim to explore how the body reacts to a combination of the flu virus and pneumococcal bacteria, focusing on respiratory infections and nasal immune responses. Pneumococcal bacteria can cause chest infections such as pneumonia, more often in young children and older adults. We want to study co-infection, which could help us develop new treatments and vaccines.
We would be using an approved nasal vaccine for the flu called the Live Attenuated Influenza Virus (LAIV) to mimic the way the immune system responds to the flu virus. Some participants will also have the pneumococcal bacteria into their nose.
This co-infection model has been well tested in younger adults, and we want to compare these results a group of older adults. The primary goal of this study is to understand if this would be safe and easy to study in this age group.We want to study two groups, A and B. Participants who take part in the co-infection study Group A will be adults between the ages of 60 and 80. They will receive the pneumococcal bacteria on Day 0, and LAIV either on Day –3 (before the pneumococcal bacteria) or Day 3 (after the pneumococcal bacteria). Participants in both groups will either get saltwater or the flu virus, and they will not know which.
Group B will receive the LAIV only on Day 0. This group will be open to older (60-80 years) and younger (18-49 years) adults. There will not receive the pneumococcal bacteria.
Throughout the study we will take samples from the nose, throat, saliva and blood to look at how the immune system responds. Participants will be asked to complete a diary to follow symptoms. Participants will collect saliva and nasal samples at home.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
24/EM/0200
Date of REC Opinion
31 Oct 2024
REC opinion
Further Information Favourable Opinion