Hepatitis C Inoculum Trial (HIT): Blood collection from hepatitis C positive donors for use in a controlled human challenge model
This important study aims to collect blood from individuals living with Hepatitis C virus (HCV) infection. The goal is to gather samples that contain the virus, which will be safely stored and used in future research. These future studies will involve healthy volunteers being purposely exposed to the virus in a controlled way, after which they will receive immediate treatment and be cured. This entire process is crucial for developing new and more effective vaccines and preventative treatments for Hepatitis C, a disease that affects millions worldwide and can lead to serious liver problems. While there are no direct personal benefits, participating can greatly advance research that could one day save many lives.
At a glance
What is this study about?
Hepatitis C is a virus that affects the liver and can cause serious health problems like liver cancer and liver failure. Currently, over 50 million people around the world are living with this infection. While there are treatments available, scientists are always looking for better ways to prevent the virus from spreading in the first place, especially through new vaccines.
This study is a vital first step towards creating a 'human challenge model' for Hepatitis C. This means that, in future studies, scientists will be able to safely expose healthy volunteers to a small amount of the virus and then treat them immediately. This method helps researchers understand how the virus affects the body and allows them to quickly test if new vaccines or treatments work. To do this, they first need to collect samples of the virus itself.
The main purpose of *this particular study* is to collect blood from people who are already infected with Hepatitis C. The blood samples will be carefully processed to separate the virus, which will then be measured and stored. This stored virus will be used in the future challenge studies, where the aim is to develop new vaccines and prevention methods to protect millions from Hepatitis C infection.
Key takeaways
- The study collects blood from people with Hepatitis C.
- The donated blood helps develop Hepatitis C vaccines.
- Participation involves one main blood donation and a few follow-up visits.
- There are no direct personal benefits, but you help future medical advances.
- Your usual medical care for Hepatitis C will continue as normal.
- You can stop participating at any time.
Who may be eligible?
You might be able to take part if you are an adult, aged 18 or over, and currently have a Hepatitis C infection, whether you've had it for a long time or recently. Before you can join, you'll have a health check-up, including a physical exam, a review of your health history, and some blood and urine tests, to make sure it's safe and appropriate for you to participate.
There are certain reasons why you might not be able to join. For example, if you have HIV, syphilis, or Hepatitis B, or if you've had certain serious illnesses like cancer in the last year or an organ transplant. You also can't take part if you are pregnant, have recently given birth, or have travelled to areas with certain mosquito-borne diseases recently. The study team will review all your information carefully to see if you meet the requirements.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you currently have Hepatitis C (either recent or long-term)?
- Are you willing for your donated blood to be used for future Hepatitis C research?
- Do you not have HIV, syphilis, or Hepatitis B?
- Are you not pregnant or haven't had a baby in the last 6 months?
- Do you not have a serious medical condition like certain cancers or organ transplants?
What does participation involve?
If you decide to take part and are found eligible after your health check, you'll be asked to donate a moderate amount of blood – about 470 millilitres, which is similar to a standard blood donation. After this donation, you'll continue to receive your usual medical care for Hepatitis C through your existing healthcare team.
Over the next six months, you will have two more in-person visits where a small amount of blood (about 4 teaspoons) will be taken. There will also be one additional phone call check-in. The total time you'll be involved in the study is expected to be no longer than six months. Remember, taking part is completely your choice, and you can stop at any time.
Potential risks and benefits
Locations (3)
- Experimental Medicine Clinical Research Facility (LEAD)City onlyOxford, England
- 56 Dean StreetApproximateLondon, England
- Mortimer Market CentreApproximateLondon, England
Common questions
What is Hepatitis C?
Hepatitis C is a virus that can cause serious liver damage. This study aims to help find better ways to prevent it.
Will I get paid for participating?
The information provided does not mention payment for participation.
What happens to the blood I donate?
The virus will be separated from your blood, measured, and stored for future studies that aim to develop new vaccines.
Will my usual Hepatitis C treatment be affected?
No, you will continue to receive your standard Hepatitis C treatment from your usual healthcare team.
Who is funding this research?
The study is supported by donations from Coefficient Giving Action Fund and Founder’s Pledge.
How to find out more
Oliver Sampson
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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