About this study

The CHIRP-01 study is looking at the immune response (i.e. how your body fights infection) to Respiratory Syncytial Virus (RSV). 

RSV is a very common cold virus that can affect people mostly during winter, causing coughs, blocked/runny noses, sore throats and sometimes sore muscles and fever. Most people do not even need to visit a doctor. 

RSV can cause more severe disease in very young babies or elderly people with chest conditions, leading to hospitalisation.

There are currently two RSV vaccines licensed for use in the UK since July 2023 and there are some ongoing clinical trials of other potential RSV vaccines. The Joint Committee on Vaccination and immunisation (JCVI) have advised a vaccination programme to offer over 75 year olds the licensed RSV vaccine in the UK. However, whilst these vaccines have been shown to be efficacious in preventing severe disease, there is much less evidence on the duration of protection afforded, their impact on milder disease and the ability of these vaccines to prevent onward transmission of the virus.

Partly this is because it is not fully understood why some people are protected from infection whilst others are not only infected but develop severe disease. As there are few available vaccines and no specific treatments available, further research in this area is therefore needed and the aim of this research project is to identify how the human immune system responds to infection with RSV and how this changes with aging. As these are understood, we will be able to design new therapies and possibly create new vaccines against this virus.

Screening Phase

This study involves an initial screening visit which lasts approximately 2 hours. At the screening visit, the study doctor will discuss the study with you give you the opportunity to ask questions and then ask you to sign a consent form. During this visit, there will be a brief interview, medical examination, routine blood tests, urine tests, breathing tests and a chest X-ray to find out if you are suitable for the study. They will also request your medical history from your GP following the visit.

Quarantine Phase

If you are eligible following screening and agree to take part, you will then be invited to take part in the main study at a time convenient to you. You will be admitted one day prior (known as Day -1) to the Imperial Clinical Research Facility. The following day, Day 0, providing all admission procedures were fine, you will then be deliberately infected with RSV by drops in the nose. You will then remain in the residential unit for 8 days if you remain uninfected, or10 days if you become infected after being given RSV.

Participants must stay in the research facility after being given RSV to prevent the virus from spreading to vulnerable people in the community. They will be seen by a research doctor and/or nurse daily throughout this period, during which time they will record any symptoms experienced, collect blood samples, perform breathing tests, and collect samples from the nose and throat.  

Follow Up Phase

After the quarantine, there is a follow up visit on Day 14, Day 28 and Day 180. After the Day 180 visit, your participation in the study will be complete.

We are looking for:

• Healthy volunteers aged 65-75yrs
• Non-smokers or ex-smokers with a pack year history of 10 pack years or less (Pack years can be calculated by the number of cigarettes packs [20 cigarettes] smoked per day times by the number of years smoked for).
• People who have been fully vaccinated against COVID-19
• People who have not had a cold in the last 4 weeks
• People who have no significant health issues
• People who have NOT received an RSV vaccine before

Each participant will be in the study for approximately 6-7 months from screening to their last scheduled visit.   

Taking part will not improve anyone’s health, although they might develop some immunity to the study virus and benefit from a general health check at screening. They will be compensated for their time if they take part, up to £2,200-2,500.  

To find out more about the study, please read the Participant Information Sheet: CHIRP01 PIS V1.1 16JAN2024 

If after reading this you would like to take part, please complete the pre-screening questionnaire. Please try to answer all questions openly and honestly to the best of your ability.  All information we obtain will be used in accordance with our privacy policy.
 
For further information about this questionnaire or any aspect of the study, please contact: flu-rsv-study@imperial.ac.uk  

Ethics

The London Fulham Research Ethics Committee (REC) has reviewed and approved this study on 26 February 2024. 

Review by an ethics committee is one of a series of safeguards intended to protect people taking part in all clinical research studies. It is a thorough process and there are many principles that are considered during the review, including weighing up the benefits against the risks. Another important consideration is making sure the potential participants receive high-quality, comprehensive information about the study in a timely fashion. The information about the human infection study sent to and discussed with potential volunteers is very detailed and there are measures in place to make sure it is understood, so potential volunteers have a full picture of what the risks are and what the study entails before agreeing to take part (this is known as informed consent).

You can find out more about Research Ethics Committees (RECs) and the Health Research Authority (HRA) approvals on the HRA website: About us - Health Research Authority (hra.nhs.uk). A REC is made up of experts from different backgrounds (for example doctors, clinical trial experts, and scientists) and members of the public.