24
Participants
Start Date
February 22, 2013
Primary Completion Date
November 26, 2013
Study Completion Date
November 26, 2013
KLH 0.1 mg
KLH will be administered as single ID injection of 0.1 mg as 0.1mL of KLH (1 mg/mL)
KLH 5 mg
KLH will be administered as single SC injection of 5 mg
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
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.
GSK Investigational Site, Cambridge
Lead Sponsor
GlaxoSmithKline
INDUSTRY