Varying Keyhole Limpet Haemocyanin-adjuvant dose combinations
Research type
Research Study
Full title
Varying Keyhole Limpet Haemocyanin-adjuvant dose combinations to explore the immune response: a human challenge study
IRAS ID
309002
Contact name
James Fullerton
Contact email
Sponsor organisation
University of Oxford / Research Governance, Ethics and Assurance
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The purpose of this research is to better understand, improve, and standardise a common method of immune challenge in healthy volunteers which uses a protein called ‘Keyhole Limpet Haemocyanin’ (KLH). KLH is available as a highly-purified formulation, and because it is not usually encountered by the human immune system (it is derived from an inedible shellfish), it allows us to study the development of immune responses right from the time it is administered. We plan to give different groups of healthy volunteers different doses of KLH with or without an ‘immune-boosting’ agent (Alhydrogel™ or Montanide ISA™51, commonly referred to as adjuvants), before measuring and comparing their response. We will then re-challenge all the volunteers a month later with different doses of KLH in the skin on their forearms, similar to an allergy test, taking images, blood samples and skin biopsies to understand the nature, time course, and variability of the immune response in each individual. The results will help us to select the best dose and preparation of KLH to model different diseases and test drugs with. In turn, this will allow earlier and better evaluation of new therapeutics.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0150
Date of REC Opinion
10 Aug 2022
REC opinion
Further Information Favourable Opinion