Dermatitis Clinical Trial
Official title:
Characterisation of the T-cell Response in Delayed Type Hypersensitivity Reactions to Keyhole Limpet Hemocyanin (KLH) and Tuberculin Purified Protein Derivative (PPD) in Healthy Volunteers
This is an exploratory study to develop methodologies for the assessment of T-cell mediated
therapies via skin immune challenges studies in healthy volunteers. The study will
investigate what is the most appropriate; skin challenge agent, time and methodology to
sample and characterise T-cells in the delayed type hypersensitivity (DTH) skin reaction.
The skin challenge agents to be used in this study will be the neoantigen Keyhole Limpet
Hemocyanin (KLH) and recall antigen Tuberculin Purified Protein Derivative (PPD). Part A of
the study will assess an intradermal (ID) KLH challenge in three subjects to assess if the
immune response to KLH is initiated by the innate or adaptive immune system. Each subject
will receive one ID dose of 0.1 milligram (mg) KLH and will be assessed for a skin
inflammatory response. Part B of the study will assess repeat ID challenges 28 days apart;
the objective will be to characterise the T-cell response to each challenge and the kinetics
of that response.
For Cohorts 1A and 1B, 16 subjects will receive an initial subcutaneous (SC) 5 mg dose of
KLH. Fifteen days later the subjects will receive 0.1 mg ID KLH dose and the response will
then be assessed 48 and 120 hours after the initial challenge. The ID KLH challenge will
then be repeated 28 days later and the response will be assessed at 48 hours (Cohort 1A, 8
subjects) and at 120 hours (Cohort 1B, 8 subjects) post challenge. For Cohort 2, a repeat
challenge of either 2 tuberculin Unit (TU) or 10 TU ID PPD will be administered 28 days
apart, to 8 subjects. The first challenge response will be assessed 48 and 120 hours post
challenge. The second challenge will be administered 28 days after the first and will be
assessed at the same timepoints. The repeat challenge 28 days later will allow an
intra-subject analysis and will determine if a subject can be used as their own control.
Part C of the study will assess repeat ID challenges of PPD and PBS; the objective will be
to characterise the T-cell response to each challenge and the kinetics of that response. For
Cohort 1, 6 subjects will receive a 0.1ml ID dose of PBS and another dose 24 hours later.
Each challenge will be assessed 48 hours post challenge. Approximately 2 subjects will have
an assessment of their normal skin as a control. For Cohort 2, a repeat challenge of either
2TU or 10TU ID PPD will be administered 28 days apart, to 6 subjects. The first challenge
response will be assessed 48 post challenge. The second challenge will be administered 28
days after the 1st and will be assessed at the same timepoint. The repeat challenge 28 days
later will allow an intra-subject analysis and will determine if a subject can be used as
their own control.
The total duration of this study for Part A is 14-18 days plus up to 30 days screening. The
total duration of this study for Cohort 1A is 56-60 days plus up to 30 days screening. The
total duration of this study for Cohort 1B is 59-63 days plus up to 30 days screening. The
total duration of this study for Cohort 2 if 2TU is used is 45-49 days plus up to 30 day
screening. The total duration of this study for Cohort 2 if 10TU is used is 48-51 days plus
up to 30 days screening. The total duration of this study for Part C Cohort 1 is 15-19 days
plus up to 30 day screening. The total duration of this study for Cohort 2 if 2TU is used is
42-46 days plus up to 30 day screening. The total duration of this study for Cohort 2 if
10TU is used is 45-49 days plus up to 30 days screening.
n/a
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