Varying Keyhole Limpet Haemocyanin-adjuvant dose combinations to explore the immune response: a human challenge study

Varying Keyhole Limpet Haemocyanin-adjuvant dose combinations to explore the immune response: a human challenge study

Chief Investigator: Dr James Fullerton, james.fullerton@ndorms.ox.ac.uk

Co-investigator: Dr Philip Drennan, philip.drennan@ndorms.ox.ac.uk

We'd like to invite you to take part in our research study.

Before you decide, it is important that you understand why the research is being done and what it would involve for you. Please take time to read this information, and discuss it with others if you wish. If there is anything that is not clear, or if you would like more information, please ask us.

First, we want to introduce you to the study and key facts. Then we will go through the study in more detail. There will be time for you to ask us any questions, and to discuss your participation with friends, relatives, and you General Practitioner (GP), if you wish. Taking part in this study is entirely your choice. 

Overview of the study

The purpose of this research is to better understand the immune system. We will do this through a ‘challenge’ study, in which healthy volunteers are given small amounts of substances which are foreign to their immune system (the ‘challenge’) to see how their body reacts to it. Such models give us important information to improve the process of developing better medicines.

If you decide to join our study:

1. You will have to attend a screening visit at our Experimental Medicine Clinical Research Facility (EMCRF), based at the Churchill Hospital site. We will ask questions about your health, perform a physical examination, and take a blood sample. If you are eligible based on the screening assessment and decide to take part, you will have to attend the research facility on a further 6 occasions over 30 days, for about an hour per visit (about 2 hours for the final visit).               

2. You will be given injections of keyhole limpet haemocyanin (KLH; trade name: Immucothel) into the muscle or skin, on up to two of the visits, with or without a medicine ('adjuvant’) which helps the immune response (either aluminium hydroxide or Montanide ISA-51). All these products are used clinically and are manufactured to the standard of medicines.                           
3. You will be closely monitored by the study team with a range of tests and procedures, including questionnaires, physical examinations, blood tests, skin imaging using Laser Doppler Imagers, and ultrasound of the lymph nodes in your armpit.              
4. On the final visit we will take a tiny sample of skin (punch skin biopsy) from up to three areas.

FAQs

Is there any reimbursement for the trial?          

You will be compensated up to £400 for your time, travel, and inconvenience.

Are there any advantages to taking part?

You will not gain any direct benefit from the study. We hope that the information we gather from this and future studies will help us to develop new treatments for diseases caused by, or affecting the immune system.

Do I have to take part?

• No, taking part is entirely your choice.
• You can withdraw at any time without giving a reason.

What are the risks of taking part?

Expected common adverse effects related to the challenge agents used in the study are limited to mild responses at the injection and other potential foreseeable risks would be similar to those seen with standard vaccinations. Full details around the potential risks are in the participant information sheet.      

If you are interested in participating in this study please email philip.drennan@ndorms.ox.ac.uk for further information.

For more information, please see the Participant information sheet here.