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

Oxford uni

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.

 

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

 

Could I be eligible to take part?

✔ You must

✖ You must not

Be aged 18-45 years old

Have any significant medical conditions

Be in good health

Be a current smoker, including vaping

Be willing to travel to our research facility in Oxford for a screening visit, and six study visits over 30 days

 

 

If you decide to join our study:

  1. You will be given injections of keyhole limpet haemocyanin (KLH; trade name: Immucothel) into the muscle or skin, on up to two occasions, 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.                           
  2. You will have to attend a screening visit, where 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).               
  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 on your forearm, using local anaesthetic.                                                                                                                                                                                     
  5. You will be free to withdraw from the study at any time you wish.  

 

“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.