Characterisation of T-cell Response to Keyhole Limpet Hemocyanin (KLH) and Tuberculin Purified Protein Derivative (PPD)

PHASE1CompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 22, 2013

Primary Completion Date

November 26, 2013

Study Completion Date

November 26, 2013

Conditions
Dermatitis
Interventions
OTHER

KLH 0.1 mg

KLH will be administered as single ID injection of 0.1 mg as 0.1mL of KLH (1 mg/mL)

OTHER

KLH 5 mg

KLH will be administered as single SC injection of 5 mg

OTHER

PBS (0.1 mL)

PBS will be administered in Part A on Day 1 as 3 ID injections and in Part C: Cohort 1 on Day 1 and Day 2 as a single ID injection

OTHER

Tuberculin PPD

Tuberculin PPD will be administered in Part B Cohort 2 on Day 1 as single ID injection of 2TU (0.04 microg/mL) in each forearm. In Part C Cohort 2 PPD will be administered on Day 1 as a single ID injection of 2TU. On day 3, if the induration is 6 mm or more; 2 ID injections of 2 TU will be administered on Day 29 in Part B Cohort 2 and 1injection of 2TU on Day 29 in Part C Cohort 2. On day 3, if the induration is less than 6 mm, subject will be re-challenged with 10 TU (0.04 microg/mL) PPD followed by 2 ID injections of 10 TU on Day 29 in Part B Cohort 2 or 1 ID injection of 10TU on Day 29 in Part C Cohort 2.

Trial Locations (1)

CB2 2GG

GSK Investigational Site, Cambridge

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY